Engineering Projects Bangalore, India Job Description Engg Brown field projects -cost estimation , business case preparation , vendor coordination ,technical spec preparation , vendor technical comparison , CFT coordination with business requirements in project . Knowledge of V model of qualification Project Gantt preparation , managing and execution coordination. Preparation , review, and approval of URS, DQ, IQ,OQ , Risk assessment , documents through Evlms the Preventive maintenance for documenting the preventive maintenance checklists and Planner for Mammalian, and Inoculum Equipment's. Responsible for up keeping the Process equipment by coordinating with cross functional team. Knowledge of Utilities like HVAC, chillers , N2 plant ,EMS/BMS , water plant is essential Process equipment like Lyo, Process tanks , centrifuges, RPHPLC , LAF Autoclave etc is needed Knowledge of clean room classification and qualification Coordinating for the preparation of process equipment's Critical spare parts. Responsible for addressing and timely closure of complaints in SAP.(Maintenance ) Responsible for Ensuring Good Engineering Practices and to comply with audit compliance, safety and Productivity. Adherence to standard operating procedures, Safety, cGMP and EHS requirements. Coordinating with vendor for carrying out activities related to statutory compliance and ensuring timely completion. Energy Management in the area. LEAN ,Six signa projects and exposure Responsible for monitoring and updating daily/weekly/monthly log sheets pertaining to Process/ Adherence to production and EHS requirements. Perform PM and Breakdown maintenance activity for Process Equipment's. Responsible for addressing and timely closure of complaints in SAP. Show more Show less

1. Master Production Scheduling (MPS) & Capacity Planning Develop and maintain an optimized MPS for Biopharmaceutical production balancing supply and demand. Collaborate with Supply Network Planning (SNP), regional supply chain, procurement and manufacturing teams to ensure accurate production scheduling. Assess production capacity and identify constraints proactively addressing bottlenecks. Ensure adherence to planning parameters, budgeted capacity assumptions, lead times and regulatory requirements. 2. Drug Substance (DS) and Drug Product (DP) Alignment Coordinate DS and DP production planning to ensure uninterrupted supplies to global markets. Manage inventory levels of DS and DP as per predetermined targets avoiding shortages and excess stocks. Align production schedules with new product launch requirements m regulatory filing strategies and market specific requirements. 3. Input Material Planning Develop a robust input material plan in line with lead time, inventory and safety stock targets. Coordinate with production to maintain accurate Bills of Materials and Master Data. Implement best practices for MRP automation . 4. Cross-functional Collaboration Work Closely with manufacturing, quality, regulatory, supply network planning and regional supply chain teams to ensure smooth execution of production plans. Work closely with cross-functional teams to ensure timely dispatches as per committed timelines. Collaborate with procurement, warehouse and quality to ensure raw material availability for uninterrupted manufacturing as per schedule. Support New Product Launches, process enhancements and changes by integrating them with MPS. 5. Performance Monitoring and Continuous Improvement Define track KPIs such as schedule adherence, supply plan vs actuals, inventory targets and service levels. Analyse data to identify patterns and make informed decisions regarding inventory levels and production schedules. Prepare reports for senior management, providing insights into planning metrics and performance. Implement lean manufacturing and planning practices to improve efficiency. Drive continuous improvement initiatives in planning and supply chain processes. 6. Leadership Lead and mentor a team of planners, providing direction and support to enhance their skills and performance. Foster a collaborative environment to ensure effective communication across departments. Show more Show less

Associate Manager - Engineering Bangalore, India Job Description: •Implementation of energy conservation measures. •Implementation of cGMP regulations. •To identify the proper training needs in the department. •Recruitment of engineering and maintenance personnel. •Ensure the satisfactory running of all equipment as per the manufacturer's specifications. •Set up objectives and targets for the personnel. •Decision making on priorities. •Delegate roles and responsibilities in the department. •To initiate modifications and projects in the department and monitor the status of the same. •To ensure the smooth running of audits. •Take decisions on changing the operations and working procedures. •To ensure the compliance of all documentation completion in the department. •To ensure the QMS items are completed within the target timelines. •To take decisions on CAPA proposal. •Budgeting for the department. •To ensure the expenditure are within the stipulated budget. •To raise CAPEX for the department. •Approval of gate pass. •Approval of commercial documents. •To authorize purchase requisitions. •To authorize invoices and vouchers for different material receipts and services performed. •To ensure all the legal requirements are met. •To interact with statutory authorities with matters concerning the legal requirements. •Ensure safe working environment for the personnel. •Ensure the statutory compliance within department. •Ensure the department personnel are follows safety. •Ensure compliance related to safety. Show more Show less

Biocon Biologics is a fully integrated ‘pure play’ biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe. Job Description. 1. Handling of OOS and OOL Investigation related to Environmental excursions and ensure closure of report on time and before batch release as applicable (report preparation, report review and closure). 2. Initiation of CAPA related to OOS and OOL for Environmental excursions and ensure its closure. 3. Keeping online tracking sheet for OOS/OOL. 4. Training of manufacturing personnel on relevantSOP's.5. Ensuring audit Compliance for Fill Finish Production. 5. Ensure the microbial events related to product (Deviations, OOS/OOTs), and microbial water excursion (OOS) investigations are timely conducted, and root cause analysis is identified out and appropriate CAPAs are identified to avoid repeat occurrence. 6. Timely assess the impact due to microbial excursion on the ongoing batches and subsequent batches and propose recommendation to the site. 7. Review of Investigation reports for data furnished for correctness of statements, evidence-based review and ensure no errors in the data and conclusions derived. 8. Involve in management review meetings to present the microbial excursions and status of closures. 9. Provide inputs during trending of microbial related deviations, OOS and propose recommendations and aseptic practise review. 10. Ensure oversight on microbial related investigations, to ensure consistency of global standards, harmonization, sharing of best practice. 11. Drive continuous improvement in microbial investigations to meet and sustain compliance with internal and external regulatory requirements. Qualifications and Experience BSc/MSc Microbiology or biotechnology or equivalent experience. 13 + Years Relevant Experience. Microsoft Office (Outlook, Excel, Word, PowerPoint, etc.) Organized Strong leadership skill Show more Show less

About the Company: At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. About the Function: Global Legal team – working as strategic business and compliance partner for the organization enabling commercial, business development, alliance, PE, strategic partnering, advising on key organization initiatives, ensuring legal and contractual framework from organization perspective. Objectives: The candidate must have the ability to continually develop their niche skills and personally have the ability and the drive to meet ever-evolving challenges. The candidate must be able to handle a high pressure ever growing and challenging work environment. The candidate must have the ability to keep pace with the changing work environment by learning and developing continuously. Candidate must have a strength-based approach and build on their existing skill set and strengths and develop and train themselves in order work on their weaknesses. The Candidate should aim to align their growth objective to the organisation's wider strategy. Key responsibilities of the Role: Responsible for end-to-end handling and closures of contracts, from negotiating, vetting, reviewing, drafting, finalization and sign off of contracts including Distribution Agreement, Product Registration Agreement, Supply Agreement, License Agreement, Term Sheet, Master Services Agreement, Statement of Works, Confidentiality Agreement, Consultancy Agreement, Safety Data exchange Agreement, Quality Agreement, Letters of Authority etc. Responsible for legal research and providing legal opinions in various matters pertaining to the business. Interacting with various internal stakeholders to ensure timely closure of agreements. Strategizing and advising the business team/stakeholders on various issues. Responsible for driving various legal projects including process improvement, contract repository management etc. Experience, Education and Skills: Preferably- 5+ years of post-qualification Experience in the Pharmaceutical Industry Candidate to be from a reputed Law College- BA LLB/BSL LLB &/or LLM Ability to work independently and manage relationship with stakeholders Ability to interact with Senior Management Good business understanding. Pharma candidate preferred. Leadership skills and good interpersonal skills Good negotiation and articulation skills Understanding of pharma industry (especially Emerging Markets). Show more Show less

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. https://www.bioconbiologics.com Education Qualification B Pharma/ BE/ B-Tech degree in Operations Management with experience in Asset Supply Planning. Experience: 8 - 12 years Roles and Responsibilities Order Management Own the Servicing of orders for regional Sales Teams in the defined customer service framework for timely issue resolution Validate demand over the horizon, assigns prioritization to demand/ orders/ customers Validates the demand with POs available, LCs required, Regulatory clearances, Artwork Details, SKU codes, IL Check, Mfg License Check, Min Shelf-Life requirement, Pre shipment documents submission to customer & timelines, Regulatory Confirmation and any other Customer Specific requirement to ensure that the plan is achieved. Analyse the order status in our systems Gather information on scheduling, material receipt and dispatch schedule Highlight any potential issues which might affect defined timelines Take end to end ownership of the assigned order for the regio Driving all documentation related to shipments with CFT teams. Drives the Shipment planning with Logistics teams and mitigates risks/ delays proactively to incur no demurrage/ penalties on shipments. Attend all relevant meetings to get data and information on all open orders for the region and their status updates Identify issues (e.g. artwork approval, batch size, minimum order quantity etc.) which are to resolved/ approved/ exempt by the sales teams. Arrange cross functional meetings to resolve bottleneck related to priority orders in order to ensure OTIF is met. Gather feedback from timely resolution of issues with concerned stakeholders Identify all outstanding/ open orders for defined priority customers Analyze issues which need immediate escalations to cross functional teams for timely resolutions Prioritize orders / customers basis defined parameters Identify key stakeholders who need to be engaged to resolve outstanding issues Provide the Head of Emerging Market SCM, with detailed analysis on all outstanding orders that are to be discussed in the meetings Supply Chain Technology and Automation Identifies opportunities for implementing IT & Automation in Order Management processes improving Supply Chain visibility Drives the implementation and rollout cycle for all IT & Technology Automations within SCM jointly with IT. KPIs Computation, Analytics & S&OP Management: Own the reporting & analytics platform and publish reports/Dashboards at defined frequency on KPIs/ Order Book/ Order Aging/ Supply Availability Phasing vs Order required dates. All required analysis in time for S & OP cycle Preparation of Monthly/Fortnightly/ Weekly dashboards/ MIS/reports & presentations from Emerging Markets Perspective. Show more Show less

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. About the Role: A detail-oriented and scientifically sound Scientific-Marketing Content Creator & Proofreader responsible for developing error-free medico-marketing content in close collaboration with marketing communications, marketing, medical and regulatory teams. The ideal candidate will combine strong scientific knowledge with marketing flair to develop and refine content that is accurate, engaging, and aligned with Biocon Biologics’ global biosimilars portfolio. This role is critical in ensuring factual consistency, scientific integrity, and stylistic quality across all global marketing materials. Key Responsibilities: Content Creation: Create scientifically accurate, engaging content for marketing collaterals including brochures, slide decks, campaigns, digital assets, infographics, and websites. Translate complex scientific data into digestible and impactful messaging for healthcare professionals (HCPs), payers, partners, and internal stakeholders. Support launch and lifecycle marketing initiatives across therapy areas such as Oncology, Immunology, Diabetes, and Bone Health. Assist in developing high-quality training materials that support global branding efforts. Proofreading & Quality Control: Review and proofread global marketing content to ensure consistency in scientific language, terminology, grammar, style, and tone. Check for alignment with approved label, medical references, and brand messaging. Ensure compliance with regulatory and legal requirements for pharmaceutical communications across key markets (US, EU, etc.). Cross-functional Collaboration: Work closely with the Marketing & Corporate Communications, Regulatory, and Medical Affairs teams. Liaise with global and regional marketing teams to understand content needs and adapt messaging as per regional nuances Brand Alignment: Ensure all content upholds Biocon Biologics' tone of voice, scientific rigor, and brand identity. Adapt content across platforms (print, digital, video, events) while maintaining a high standard of scientific communication. Candidate Pre-Requisites: Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (PhD, MD, BPharm, MPharm, MSc preferred). 4–8 years of experience in medical writing, scientific content creation, or marketing communications in the biopharma or healthcare industry. Exceptional command over written English; impeccable grammar and proofreading skills. Eye for detail with a scientific mindset and marketing acumen. Strong understanding of global regulatory standards for pharma marketing (e.g., FDA, EMA guidelines, OPDP norms). Proficiency with Microsoft Office (especially PowerPoint), referencing tools (e.g., EndNote), and content management platforms. Team player with strong collaboration and project management skills. Show more Show less

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated “pure play” biosimilars organisation in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, US and Japan. Biocon Biologics has a product pipeline of 28 molecules. Biocon Biologics believes that strong partnership offers enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. Key Responsibilities Implementing and configuring SAP FICO requirements, setting up financial accounting and controlling processes, analysing and improving business processes, customizing and configuring to meet the requirement with standard SAP, testing and support along with the user training, documenting configuration and procedures. Professional Experience / Qualification CA/ CMA / MBA in Finance, including a minimum of 3 years of experience on core finance & accounts and 8 to 10 years of experience as a FICO consultant or Lead handling SAP ECC / SAP S/4HANA implementation, enhancements and support. In-dept understanding of Finance & Controlling sub-modules like General Ledger, Accounts Payable, Accounts Receivable, Asset Accounting, Cost Elements, Cost Centre Accounting, Profit Centre Accounting, Product Costing, Material Ledger and Actual Costing. Understanding on Funds Management, Business Planning & Consolidation, Inter-Company transaction and Reconciliation, Project System. Experience in working in an on-site & offshore model, coordinating with stakeholders from various geographical locations. Excellent oral / written communication skills. Self-starter, with the ability to work and execute independently with minimal guidance. SAP FI/CO certification is a good to have. Equal Opportunity Employer Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorisation and employment eligibility verification requirements of the Immigration and Nationality Act. Show more Show less

Responsibilities: Primary Responsibilities: 1. Regulatory Filings and Compliance of regulatory documents: • Coordinating for planning and execution of device regulatory submissions and all other regulatory related activities, globally • Responsible to assist in activities of authoring, review, submission of device related sections of different combination products • Responsible for preparing the response and submission for any agency queries information request on device activities. • Responsible for ISO 13485/ CE certification audit compliance pertaining to regulatory activities and contributes towards post audit management. • Responsible for device related sections in post approval variation submission of different combination products. • Responsible for preparing the technical files and getting NBOp as per article 117 of EU MDR (2017/745) • Ensuring compliance with GSPR as per Annexure I EU MDR (2017/245) • Responsible for activities associated to the devices, in the dossier preparation for biosimilar product under BLA/IND/MAA and perform review, as required. • Coordinating with partners, customers and authorities for dossier finalization, query response and submission as required. • Responsible for device regulatory related SOPs revisions/update as required within the QMS framework. • Responsible for periodic update collation conducted with the purpose of tracking revisions in device regulatory frameworks and guidelines and ensuring cross functional communication for initiating effective implementation wherever appropriate • Regulatory activities including but not limited to: contributing, executing and assisting the team with preparation of medical device CE Marking technical file, registration dossiers for emerging markets, updating device information in drug registration dossier as appropriate to reflect due to deficiency response, post approval changes, etc. • Supporting activities for ensuring GMP compliance. 2. Contribute in preparatory for liaising with – Regulatory Authorities/ Customers for International market 3. Technical Dossier Review: • Process owner and reviewer (as assigned in specific cases) of all technical documents (documents related to development, manufacturing and control of drug substance, excipients, drug product and devices). • Ensuring good documentation practice within the team. 4. Review of deviations, change control and other routine QMS governing activities: • Review and contribute to action items related to change control, deviations, CAPAs and other documents related to medical devices Show more Show less

Molecular Biology activities like plasmid and genomic DNA preparation, PCR amplification, restriction digestion, molecular cloning, sequence confirmation, involved in vector construction for stable and transient gene expression. Routine cell bank preparation of microbial and mammalian cells. Analytical skills related to protein estimation and characterization like, ELISA, SDS PAGE/Western Blot, Octet and HPLC. Standard cell culture activity such as vial thaw, subculturing, transfection, single cell cloning, fed batch, monoclonality assurance. Experience in bacterial and yeast expression systems preferred. Routine documentation in electronic notebook. Preparation of SOP/GM and development reports. Industrial experience of 4-6 years in cell line development. Show more Show less

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. About the Role: A detail-oriented and scientifically sound Content Editor & Proofreader responsible for ensuring all content produced by GMC are error-free. The ideal candidate will combine strong scientific knowledge with marketing flair to ensure that content is accurate, engaging, and aligned with Biocon Biologics’ global biosimilars portfolio. This role is critical in ensuring factual consistency, scientific integrity, and stylistic quality across all global marketing materials. This may require close cross-functional collaboration with marketing communications, marketing, medical and regulatory teams. Responsibilities: Content Editing, Proofreading & Quality Control: Review and proofread global marketing content to ensure consistency in scientific language, terminology, grammar, style, and tone. Check for alignment with approved label, medical references, and brand messaging. Ensure compliance with regulatory and legal requirements for pharmaceutical communications across key markets (US, EU, etc.). Assist in developing high-quality training materials that support global branding efforts. Support launch and lifecycle marketing initiatives across therapy areas such as Oncology, Immunology, Diabetes, Ophthalmology and Bone Health. Cross-functional Collaboration: Work closely with the Marketing & Corporate Communications, Regulatory, and Medical Affairs teams. Brand Alignment: Ensure all content upholds Biocon Biologics' tone of voice, scientific rigor, and brand identity. Adapt content across platforms (print, digital, video, events) Qualifications: Bachelor's/Master’s in English, Journalism, Communications, or Life Sciences. 4–8 years of experience in content creation, editing, proofreading, or content review, preferably in pharmaceuticals, healthcare, or life sciences Exceptional command over written English; impeccable grammar and proofreading skills. Eye for detail with a scientific mindset and marketing acumen. Strong understanding of global regulatory standards for pharma marketing (e.g., FDA, EMA guidelines, OPDP norms) is desirable. Proficiency with Microsoft Office (especially PowerPoint) Team player with strong collaboration and project management skills. Show more Show less

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. About Finance Function: We believe in creating a team that is not only best in class and sets new benchmarks but more importantly understands that a TEAM mean Together Everyone Achieves More. At Biocon Biologics, Finance is one of the major pillars and an essential ingredient to a successful business Key Responsibilities: Book close and compliance: Closing books of account on monthly basis and preparing book closure schedules Preparing Financial statements including PL, Balance Sheet and Cash Flow Statutory and Tax Audit of standalone financials Tracking actual cost v/s Budget for support functions Participate in compliance with Companies Act 2013 requirements like CSR, Related party, CARO Liaise with third party accounting, tax service providers and other consultants on local regulatory/accounting/audit compliances Strong knowledge of IndAS/IFRS Operations and accounting: Review/prepare month end accruals, intercompany reconciliation, balance sheet schedules, Income statement trend analysis; Financial reporting and analysis to various stakeholders to support decision making Participate in special finance projects, with an eye to automate processes Work with onshore and offshore finance team reporting within Biocon Biologics group, to monitor all transactions and ensure the smooth running of day-to-day accounting operatons Education, Experience and Skill: Qualification – Chartered Accountant Experience 5+ years (post qualification) Big 4 will be preferred for the role. Experience of preparation/audit on financial statements, disclosure Hands on experience with SAP will be an added advantage Excellent analytical skills Proficient in MS Excel and PowerPoint Excellent Communication Skills (Written & Oral) and Networking skills Flexibility & open mind to look at dynamic and ever-changing business environment and needs Time management & ability to prioritize work / Multitasking Show more Show less

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. Role/Job Description: Program Associate for Device development programs for Advanced and Emerging markets Manage timely delivery of device development for Insulin, MABS programs and new products in development Prepare, track, monitor and control budget for device development. Manage monthly expenses on the project Prepare and publish integrated project plans in Microsoft projects and customized excel, which comes independently from project managers and other CFTs for the program Weekly, Monthly and Quarterly reviews with teams Documenting and publishing minutes and actions from each meeting Prepare team charter for every program assigned and manage resources for the program Work with cross functional team members to constantly improve systems and process to remove redundancies and bottlenecks Work with peers in PMO office to continuously improve the project and program management function Technical / Functional Skills: Total Experience – 5+ years Project management experience (at least 3+ years) Experience in Drug delivery systems is good to have Proficiency in Microsoft projects and project management tools (at least 3 years) Behavioral / Management / Other Skills: Team player Good written and oral communication skills Team Details: Individual contributor Show more Show less

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. Responsibilities – Release standard cost in system and monitor actual product cost. Monitor operational expenses and variance analyses vs. budget. Monitor operation performance and prepare monthly MIS on operation performance. Support to prepare annual budget and forecast. Closely work with operations team, evaluate, and monitor cost optimization initiatives. Prepare statutory schedules/annexures/quantitative details. Support for cost audit, statutory audit. Independently handle the Inventory valuation ML Run and reconciliation inventory dump with financial (GL) Inventory valuation for BBL Entity and finalize the JV in system Skills Required – Proficient at working with multiple data sets. Detail oriented and analytical though process. Strong grasp on SAP FICO, CO modules and MS office tools Experience : 1-2 Years in pharma manufacturing Show more Show less

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. About the Function: Projects & Engineering function manages capital investments for expansion of DS and DP manufacturing facilities globally that are either greenfield or brownfield. With a team of about 50 and split into various verticals including Process Engineering, Automation and Instrumentation, Electrical, Mechanical, Project Management, Commercial, Civil, and Site execution. Project manager will manage the project in close coordination with all the stakeholders to ensure scope of the project is met. About the Role: Responsible for management of the project from initiation, planning, execution, monitoring, controlling and closing of the project. Keeping a track of Project cost, schedule, scope and cash flow. Provide regular project updates, reports and status information. Coordinate with other Project verticals in preparing and tracking the project Identifying project risk, constraints and assess the same periodically. Ensuring compliance with statutory requirements. Finalizing the contracts of Design consultant and Construction management firm. Ensure effective communication with team members and stakeholders Strong stakeholder management skills Adherence to safety, Health, and Environment measures Open to travel(get deployed) in any part of India/out of India based on project requirements Qualification Required: Degree: BE/B.Tech in any field Experience : 4 to 6 years in project management Course: PMP Preferred Excellent proficiency with office 365 skills (PPT, Excel, Word, MS project and other project related reporting and tracking software knowledge is required) Show more Show less

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. About the Function: Projects & Engineering function manages capital investments for expansion of DS and DP manufacturing facilities globally that are either greenfield or brownfield. With a team of about 50 and split into various verticals including Process Engineering, Automation, and Instrumentation, Electrical, Mechanical, Project Management, Commercial, Civil, and Site execution. Mechanical lead will serve as technical resource in facility and utility design meeting User Requirement Specifications. Reporting to the Design Lead, he/she will work across various organizational functions including Operations, Quality and, external consultants and vendors to help ensure design, quality and qualification timelines meet Business Objectives. About the Role: Act as a Subject Matter Expert in HVAC, Clean and black utilities, Cleanrooms, process and utility piping, fire fighting systems, warehousing, and material handling. Manage the design (lifecycle- URS to site qualification) for Utility Equipment like Air Handling Unit, Air Compressor, Cooling tower, Chilled water and glycol systems and distribution, Gas generation and distribution, Plant Steam generation and distribution, condensate recovery systems, Water pretreatment, WFI and purified water storage distribution, pure steam distribution, warehouse racking and material handling systems, Cleanroom panel and furniture including LAF’s and pass boxes. Strategic planning: Establish concept/ basic and detail engineering reports for designated projects. Manage design and execution in collaboration with external consultants, Internal stakeholders, to deliver projects in a timely manner, meeting design and quality requirements. Preparation of process flow sheet, capacity, facility and equipment layouts, utility compilation, concept/ technical documentation, scheduling, and budget proposals. Aware of Bioprocess manufacturing processes and process automation. People manager- effectively lead and coach direct reports Aware of technology process trends and benchmarks in the industry. Benchmark against global standards and in compliance with regulatory standards. Good communication and interpersonal and troubleshooting/ problem solving skills. Ability to navigate diverse organizational landscapes with dynamic blend of technical acumen and leadership capabilities. Adherence to safety, Health, and Environment measures and provide sustainable solutions. Qualification Required: Degree: BE/B.Tech/ME/M.Tech/ Course: Chemical/Mechanical Experience: 10+ years in Pharma/Biopharma/Biologics manufacturing Show more Show less

S&OE & Supply Operations: Deploying the S&OE process. Ensuring the S&OE meetings take place, gathering required inputs, preparing for the meetings, facilitating and summarizing them to drive decision making and prepare for the following weekly cycle respectively. Building a strong integration of planning with execution through the interaction of S&OE and S&OP. Keeping participants on track and moving toward managing execution priorities, balancing short-term demand and supply and dealing with S&OP plan exceptions. This is done for the defined cadence (weekly) and execution horizon (0 — 12 weeks). Validates the demand with POs available, LCs required, Regulatory clearances, Artwork Details, SKU codes, IL Check, Mfg License Check, Min Shelf Life requirement, Pre shipment documents submission to customer & timelines, Regulatory Confirmation and any other Customer Specific requirement to ensure that the plan is achieved. Drives batch release and prioritization with QA and QC for meeting the plan and revenue targets. Drive weekly demand – supply meetings with Regional Commercial teams. Order management and driving all documentations related to shipments with CFT teams. Drives the Shipment planning with Logistics teams and mitigates risks/ delays proactively to incur no demurrage/ penalties on shipments. Shares the Supply plan with dates of Release and Shipment with the larger CFT teams and S&OP stakeholders Lead the effort to implement and advocate S&OE: Spearhead the S&OE initiative and champion it across the organization by being the main point of contact for S&OE related queries or discussions. Prepare for the S&OE meeting: Prepare and share a pre-read for the meeting which contains a list of agenda items and data that can inform decision making. Maintain a comprehensive view of demand, supply and financial aspects of supply chain operations and use it to identify short-term executional issues. Highlight ways that link tactical planning with granular execution (in case of significant deviations) to control operational costs. Additionally, identify and highlight risks and opportunities to inform decision making in the S&OE meeting. Facilitate the S&OE meeting: Facilitate the S&OE meeting in the form of a live working session, ensuring that all information is presented and discussed, all stakeholders are engaged, decisions are made and agreed upon, and execution plans are documented with owners and completion dates. Lead the effort to implement and advocate S&OE: Spearhead the S&OE initiative and champion it across the organization by being the main point of contact for S&OE related queries or discussions. Prepare for the S&OE meeting: Prepare and share a pre-read for the meeting which contains a list of agenda items and data that can inform decision making. Maintain a comprehensive view of demand, supply and financial aspects of supply chain operations and use it to identify short-term executional issues. Highlight ways that link tactical planning with granular execution (in case of significant deviations) to control operational costs. Additionally, identify and highlight risks and opportunities to inform decision making in the S&OE meeting. Facilitate the S&OE meeting: Facilitate the S&OE meeting in the form of a live working session, ensuring that all information is presented and discussed, all stakeholders are engaged, decisions are made and agreed upon, and execution plans are documented with owners and completion dates. Follow-up post S&OE meeting: Ensure that decisions from the meeting are communicated to each function/department/team to ensure that execution is taking place. Support S&OP: Take the output of S&OE to S&OP as key issues need to be escalated for decisions. Present the impact of cost, inventory or service identified from demand and supply reconciliation from S&OE in S&OP. Highlight the impact of change made in the production and purchasing plans during the S&OE process. Ensure timely decisions and executions via a closed loop between S&OP and S&OE. Sustain the S&OE process : Ensure that the S&OE process is sustained to the intended level of maturity. Onboard newcomers from different functions on the process and engage them on the key expectations. Support in hiring and training demand and supply planners. Share and reapply best practices with other business units/geographies. Improve the S&OE process: Report metrics back to the S&OE decision maker (usually commercial in high maturity organizations) and the team to identify progress and root causes. Use analytical tools to understand areas for opportunity and change. Document current process and work with the S&OE decision maker on continuous improvement, challenges with the process and options to improve the process. Continuously seek feedback from stakeholders on the process, meeting effectiveness, metrics and subsequent activities to identify issues to resolve. Periodically conduct health checks on the process and outcome. Show more Show less

Job Description: Pending PR review/Analysis (Qty, Material code, Brand, MOQ, Others) Floating inquiries to multiple vendors (RFQ) Upon receipt of quotes, prepare price comparison sheet Suggest alternate wherever applicable to user department & share COAs Track AVD status from user department Submit necessary documents with approval to Buyers team to create POs Follow-up with buyers' team for timely completion of POs Coordinate with vendor for documents in order to create new vendor code in MDG Sharing open orders details to user and follow up for Spot and Phase order from suppliers. Follow-up with vendors for import shipments Follow up for Shipping documents with vendor and forwarding to logistics for clearance. Review shipping documents & nominate FF with logistics Organise technical writeup/Import License from user department & share to logistics for import shipment clearances Follow-up with logistics for shipment delivery at site Co-ordinate for Bond-to-Bond shipments with Vendors, Buyers, & IDT team to generate Bill of Entry Supporting documents from vendor to apply impot license /NOC Monthly Meetings with critical vendors PO amendment clearance & invoice queries with vendors Vendor payments follow with finance for a clear understanding and update status to vendor, also follow for advance payments. Communication with vendors through regular meetings and discussions to understand their challenges and support (monthly) Addressing the issues with WH team to timely submitting the invoices to finance Follow up for RWC and DTA endorsement documents from IDT and sharing the same to vendors Conduct due diligence by verifying documents such as SOW/MSA Coordinate with users to obtain necessary approvals from the HOD and finance to comply audit. Group Negotiations for common vendors (Weekly connect) Share pending POs to vendors on monthly & get the updates Share delivery schedule to user department on timely Arrange vendor meetings to discuss on pending orders, new product qualification, negotiations.... Follow up with finance for pending payments Address quality issues raised by users and taking care of material rejection activities Identify AVD for existing brands & share COAs to end user team Arrange AVD samples from vendors for evaluation Follow-up with user team for AVD qualification and implement for cost savings Update Savings file on regularly & submit to HOD (Monthly) Generate spend report on Monthly to present on department review meetings (Monthly) Share high ageing POs to users to short close (Monthly) Follow up with user to get update on POs to be short closed Support finance on any invoice queries for accounting purposes (Monthly) Verifying and provide clearance to BRM to create new material codes Weekly Meetings with CFT (R&D) Show more Show less

Position: Competitive Intelligence Analyst – Pharma/Biotech. Experience Level: 2–4 years Educational Background: Postgraduate degree in Pharmacy/Biotechnology is preferred; MBA is a strong advantage. Job Description: We are looking for a motivated and detail-oriented Competitive Intelligence (CI) Analyst with 2–3 years of relevant experience in the pharmaceutical and biotechnology industry. The ideal candidate will support strategic decision-making by generating insights into the competitive landscape, product pipelines, clinical development, and market dynamics. Key Responsibilities: • Identify and monitor key competitors across relevant therapeutic areas within the pharma/biotech sector. • Collect, curate, and analyze data on competitor activities, including: o Product pipelines and R&D investments o Clinical trial updates and outcomes o Regulatory milestones (approvals, submissions, designations) o Patent landscapes and exclusivity timelines o Strategic alliances, M&A activity, licensing, and collaborations o Financial performance and market share analysis • Track and summarize global regulatory and policy developments impacting the industry (e.g., drug pricing, reimbursement, IP law changes). • Provide regular updates and deep-dive reports to internal stakeholders to support portfolio strategy and forecasting. • Proactively monitor emerging trends, disruptive technologies, and scientific innovations relevant to our business. • Contribute to the preparation of dashboards, trackers, and presentation materials for leadership and cross-functional teams. Candidate Requirements: • 2–4 years of hands-on experience in Competitive Intelligence, Market Research, or Strategy roles within the Pharmaceutical or Biotech industry. • Strong analytical and research skills with the ability to synthesize complex information from diverse sources. • Proficiency in MS Office tools (Excel, PowerPoint, Word) is a must; experience with competitive intelligence databases (e.g., GlobalData, EvaluatePharma, Cortellis) is a plus. • Excellent verbal and written communication skills; ability to create clear, concise, and impactful reports and presentations. • Postgraduate degree in Pharmacy, Biotechnology, or Life Sciences is preferred; MBA or management qualification is an added advantage. • Self-motivated individual contributor with a proactive approach to problem-solving and critical thinking. • High attention to detail and commitment to accuracy and timeliness in deliverables. • Strong sense of curiosity, business acumen, and ability to work cross-functionally.

Senior Director - Insulin Engineering Bangalore, India Job Description: Manage the maintenance of pharmaceutical manufacturing equipment, and facilities, ensuring adherence to quality standards and best practices to ensure ZERO downtime. Oversee repair, and calibration of manufacturing equipment and facilities to minimize downtime and ensure uninterrupted production. Provide leadership and mentorship to engineering staff, fostering a culture of continuous learning, development and high performance. Monitor and analyse key performance indicators (KPIs) to assess engineering department performance and identify areas for improvement. Stay abreast of industry standards, regulations, and advancements in pharmaceutical engineering to drive innovation and maintain competitive advantage. Develop and implement comprehensive energy management strategies and initiatives to optimize energy consumption, reduce energy consumption, and minimize environmental impact across pharmaceutical facilities. Have good experience on Lyophilisers, Centrifuges and Chromatography columns Proven track record of successfully leading engineering teams and managing complex projects from conception to completion Excellent leadership, communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, senior management, and external stakeholders Ensuring completion of documents related to maintenance, training, validation, calibrations on time through periodic review to ensure GMP, HSE, Regulatory compliance. Capex/Opex, New project planning and control - Planning for Capex, Opex, any new project and its effective monitoring to ensure its completion within time and budget. Weekly/ monthly monitoring of Capex/Opex consumption along with all section heads. Experience in handling USFDA and other agencies audits & ensuring compliance. Qualification & Requirements: B.E. / B. Tech (Mechanical) 20+ years of API / Vaccines / Biotech industries experience in the field of engineering services of Plant & Utility maintenance Pharma/Biotech industry experience is a must. Experience in API/Vaccines/Biotech engineering is a must. Experience working in the insulin engineering domain is a plus.