35 Biologics Jobs

Regulatory Affairs Job Opportunity! Desired Experience : 3- 15 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Manager/ Manager/ Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited) Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc. Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc. Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO. Application for Post Approval Change(s), Variations and Comparability packages Author, review and submission of responses to India, EM, WHO and Regulated markets.. Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc.. Handling the Health Agency audits for India, EM, Regulated and WHO inspections Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External). Review of Artworks (Labels and Package Insert) and Pack Profiles. Any other regulatory support required by the organization per submission need. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for "Regulatory Affairs"

Dear Candidate , we are hiring for Down Stream Process Executives & Operators Position . Experiance in handling the following Equipment Qualification: Bsc/Msc/ITI/B Pharmacy • M Pharmacy/Diploma/Btech/Any Degree 1 Chromatography column and system handling. 2 Column Packing (BPG And Chromoflow) 3 TFF System 4 Centrifuge system 5 Filtration, Filter Integrity,Buffer Preparation, CIP_SIP 6 Expertise in documentation QMS/GMP Compliance/Process Awareness Interested candidates please share your CV through Whats app (9381915043) Male Candidates & Biologics Company's only Preferable. "IMMEDIATE JOINERS ARE PREFERABLE"

Walk-In Drive Hyderabad | June 1, 2025 Join our growing team at OneSource The new way to CDMO We're hiring for multiple roles across our R&D and Manufacturing facilities in Bengaluru. Walk-In Interview Details: Date: Sunday, June 1, 2025 Time: 9:00 AM 4:00 PM Venue: Oakwood Residence, 115/1, Road No. 2, Financial District, Gachibowli, Hyderabad, Telangana 500032 Open Positions: Process Development Lab (Unit 1, Bommasandra) Research Associate | Sr. Research Associate | Scientist Qualification: B.Tech / M.Tech (Biotechnology) Experience: 2 – 12 years Drug Substance Manufacturing (Unit 2, Doddaballapura) Executive | Sr. Executive Qualification: MSc / B.Tech / M.Tech (Biotech, Microbiology) Experience: 2 – 8 years Drug Product Manufacturing (Unit 2, Doddaballapura) Executive | Sr. Executive | Team Leader Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm Experience: 2 – 12 years in sterile injectables

Key Responsibilities: Execute routine downstream operations including chromatography (affinity, ion exchange, HIC), filtration techniques (TFF, UF, DF, NF), buffer preparation, and formulation of mammalian cell culture-derived products. Maintain accurate documentation including batch records, deviation reports, SOPs & other QMS elements. Support scale-up and tech transfer from lab to pilot/production scale. Ensure strict compliance with cGMP and safety protocols. Collaborate with QA/QC, maintenance, and engineering teams for smooth operations. Troubleshoot process deviations and contribute to root cause analysis and CAPA implementation.

Key Responsibilities: 1. Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. 2. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. 3. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. 4. Cross-functional Collaboration: Work closely with R&D, Clinical Development, Quality Assurance, and Manufacturing teams to support regulatory activities, resolve regulatory issues, and facilitate product development and registration. 5. Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including those set forth by regulatory authorities such as the CDSCO, FDA, EMA, and other global agencies, throughout the product lifecycle. 6. Regulatory Agency Interactions: Serve as a primary point of contact for regulatory agencies, participating in meetings, teleconferences, and regulatory inspections as needed to address inquiries and facilitate approvals. 7. Product Labelling and Promotional Material Review: Review and approve product labelling, promotional materials, and advertising to ensure compliance with regulatory requirements and company policies. 8. Regulatory Document Management: Maintain regulatory files and documentation in accordance with company procedures and regulatory standards, ensuring accessibility and traceability. 9. Risk Management: Identify potential regulatory risks and develop mitigation strategies to address them proactively, while fostering a culture of compliance within the organization. 10. Training and Development: Provide training and guidance to internal stakeholders on regulatory requirements, processes, and best practices to enhance regulatory compliance awareness and capabilities. Qualifications: Bachelor's or Master's degree in a relevant scientific discipline (e.g., biology, pharmacy, chemistry) or regulatory affairs. 9-10 years of experience in regulatory affairs or quality assurance within the biopharmaceutical industry, with specific experience in biological products preferred (rDNA). Strong knowledge of regulatory requirements and guidelines for biological products, including CDSCO, FDA, EMA, and other global regulations. Experience in preparing and submitting regulatory documents and interacting with regulatory agencies. Excellent communication, interpersonal, and problem-solving skills. Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously. Proven ability to collaborate cross-functionally and influence stakeholders at all levels of the organization

Qualification: MSc / B.Tech (Chemical) / B.Pharm with MBA or PG Diploma in Supply Chain Management Experience & Skills (Essential): 35 years of experience in Opex procurement, preferably in Pharmaceutical R&D, CRO, Discovery Research, or CRAMS industry In-depth knowledge of procurement cycle and CRO/R&D-related activities Hands-on experience in procurement of: Lab chemicals, consumables, glassware, chromatography columns MRO items (engineering, maintenance, spares) Biologics-specific materials (mandatory) Experience in managing long-term contracts: ARC, AMC, O&M Exposure to equipment services procurement Strong data management and reporting skills (MIS, PPTs, Excel) Proficient in computer applications and ERP systems Excellent communication skills for coordination with international suppliers and internal stakeholders Proactive, quality-focused, and problem-solving mindset Job Responsibilities Ensure timely procurement and delivery of chemicals, Opex materials, and services Follow SOPs and procurement policies diligently Handle estimate requests, obtain competitive quotations, and prepare comparative statements Coordinate with scientific teams for indent processing and approvals Create and circulate POs; ensure supplier acknowledgment Liaise with logistics for timely delivery and documentation Coordinate with scientific teams for material receipt and issue resolution Ensure timely supplier payments in coordination with finance Identify and onboard new vendors; negotiate for cost-effective procurement Submit MIS reports regularly Support new business projects and vendor consolidation Manage consolidated and open orders efficiently

Role- AGM- International Business development- LATAM; East Europe / Russia CIS Company- A leading Biopharmaceutical Company Location- Bangalore Reporting To- VP- BD Roles and Responsibilities This role requires a dynamic individual with excellent analytical skills, strategic thinking, and the ability to manage complex projects and partnerships across semi-regulated markets, including Emerging Markets Latin America, Europe, . Expertise in sales and marketing within these regions is essential. Develop international business strategies to drive growth in overseas markets. Identify new opportunities for product launches and market expansions. Analyze market trends, competitor activity, and customer needs to inform business decisions. Deep & hands on understanding on the Documentation, Regulatory ecosystem/landscape, Dossier preparation to submission, facilitation at target market Identify and evaluate opportunities for in-licensing and out-licensing of Plasma Derived Products / Critical Care / Oncology / Vaccine / Biohpharma products across semi-regulated markets. Manage relationships with key customers, distributors, and partners. Will be responsible for managing International BD for regions such as- LATAM; East Europe / Russia CIS Desired Skills Post Graduation Degree in Business Management or Life Sciences. Total 15+ years of relevant pharmaceutical industry experience. Strong background in bio-pharmaceutical international business, particularly in semi-regulated markets such as Latin America, Europe, Emerging Market Expertise in sales and marketing within these regions. Sound knowledge of the global pharmaceutical industry (Biologics (Biopharm; Oncology. Critical Care, Vaccines. Strong analytical skills with advanced knowledge of Excel and PowerPoint. Excellent verbal and written communication skills with the ability to network effectively.

Job Description (Head R&D) 1) To build and direct a team for the development of processes for the commercial manufacture of plasma derived therapeutic proteins. The responsibilities will include the following; a) Identification of plasma derived products that can be developed for commercialisation. b) Review of published literature including patents to understand the existing product, process and formulation. c) Plan the development of scalable processes for the purification and formulation of proteins from human blood plasma. d) Plan for process validation, packaging material development, stability studies, alternate vendor development studies. e) Coordinate training, scale-up and technology transfer to production including trouble shooting for Production batches. f) To continue to evaluate the processes for improved yield and purity, incorporating the latest technologies so as to be able to deliver products that are in line with global quality standards. 2) To build and direct a team for the Analytical development of pharmacopoeial & in-house test methods for products developed by the process development team. The responsibilities will include the following; a) Identification of compendial methods for quality testing of plasma derived therapeutic products, human plasma bags received from blood banks, microbiological tests and chemical tests for raw materials/packaging materials. b) To develop in-house methods where suitable compendial methods are not available. c) To validate all test methods as per ICH guidelines d) To coordinate training and transfer of test methods to QC departments for routine batch testing and release. e) To continue to evaluate the methods and incorporate the latest test methods in accordance with the pharmacopoeial revisions to deliver good and safe quality products to the market. 3) To plan and direct a team for preparation, review and transfer of documents to QA and concerned departments. The documents will include the following; a) Process development reports (PDRs) for all products taken up in Process R&D b) Technology Transfer Dossier (TTD) for process / method to Production / QC c) Master Manufacturing Process & Formula d) Process Validation Reports e) Cleaning Validation Reports f) Analytical Method development/ qualification reports and STPs g) Technical documents for Regulatory submissions to Drug Offices and Product registrations for export to other countries.

Greetings from Kashiv Biosciences!!! We are looking for Upstream Process Specialist for our Biosimilar manufacturing facility based out of Ahmedabad. Following are the Roles and Responsibilities Roles & Responsibilities Responsible for Upstream Process for Microbial Cell culture and Mammalian Cell culture. Should have exposure on various F ermentation techniques. Qualification and validation of equipment. Exposure to Perfusion process and technique is must. Candidate Details The candidate should have worked in Biosimilars Upstream production(Microbial/ Mammalian Culture) Exposure to Regulatory Audit is Must. Should be aware of QMS Documentation. The candidate should have good communication skills. Interested candidates Please share the resumes at my manan.hathi@Kashivindia.com

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: General Manager Business Development & Portfolio( Emerging Markets) Job Requisitions No : 12956 Job Description Skill Required Manage & ensure Budget activity in alignment with the Finance Teams, providing the annual Budget File based on existing Portfolio and upcoming registrations, Manage project milestones, prioritization, defining timelines & tracking and reporting progress with R&D Qualification Required MBA Marketing Roles and Responsibilites Establish relationships with development companies specialized in injectables & oral generics, added value generics, specialty pharma products Identify gaps in the existing portfolio, evaluate complimentary products for portfolio Manage & ensure highly organized deal negotiation process involving preparation of non-binding offers, carrying out due diligence process, finalizing binding offers and then contract negotiation process engaging all key stakeholders within the organization Plan and execute end-to-end activities including product development, registration, launch and actively involved in implementing pre/ post marketing activities, Create financial business cases of the projects after consulting with EM teams for inputs on current market, forecast & market shares, Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Essential Relevant skills / Industry experience Preferred exposure to CVS/CNS/Biologics/Biosimilars marketing, Experience in as similar role with strong experience of In-licensing management with pharmaceutical prescription drugs in the EM/US/EU market 15-20 yearsexperience cross BD / Sales / Marketing / Portfolio / Strategy with minimum 5-7 yearsexperience of In-licensing Relevant professional / Educational background Good business acumen, Impressive & demonstrated career record in a similar position at a similar level, Strong analytical and problem-solving ability, Ability to influence at a senior level, both internally and externally, Good IT skills (Word, Excel, PowerPoint and Outlook) High on energy and enthusiastic about achieving high levels of excellence, Any Other Requirements (If Any) Previous experience managing a P&L and understanding of business financial objectives, Cross-cultural organizational awareness Skilled relationship builder, pragmatic, strong but subtle influencing style, Credibility and authority to provide strong leadership in a dynamic culture, Commercially aware with good analytical and problem-solving skills, Flexible interpersonal skills to build strong internal networks at all levels, win trust and break down barriers quickly Compensation / Reward As per Industry Standard Location: Ahmedabad, GJ, IN, 380054 Travel: 50% 75% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 10 Apr 2025

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

Hiring professionals with expertise in the analytical method development and characterization of biologic molecules. Hands-on experience with analytical techniques such as HPLC, UPLC, Capillary Electrophoresis, and Mass Spectrometry is required. Experience in method development, qualification, and transfer is highly desired. Guiding and mentoring juniors is a plus. Preferred candidate profile

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legislation, guidelines and customer practices. 10. Approval of Artworks. 11. Undertake and manage regulatory inspections. 12. Responsible to handle the SUGAM portals and Online Drug licencing system and National single window system (NSWS). 13. Complete knowledge on ROW and EU market registration. 14. Query response submission received from various M. 15. Coordination with the relevant departments for completion of Regulatory works.

He/She will be involved in day-to-day hands-on research activities related to large molecule drug discovery, antibody discovery, display technologies, multi specific immunofusions, ADCs, studies with both human & murine immune cells, tumor biology Required Candidate profile •experience in small and large molecular drug discovery •Hands-on experience in in vitro functional assays •solid foundation in molecular and cell biology

Project Role : Enterprise Solution Architect Project Role Description : Lead the development of complex solutions across multi-tower and/or multi- service transformational opportunities. Architect end-to-end integrated solutions leveraging the best mix of offerings, assets, and capabilities to maximize value for the client and Accenture. Ensure alignment of solution to client's organization goals. Must have skills : Oil and Gas Upstream Good to have skills : NA Minimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Enterprise Solution Architect, you will lead the development of complex solutions across multi-tower and/or multi-service transformational opportunities. You will architect end-to-end integrated solutions leveraging the best mix of offerings, assets, and capabilities to maximize value for the client and Accenture. Your role will involve ensuring alignment of the solution to the client's organizational goals. This is a senior-level position in Solution Architecture with a focus on the Oil and Gas Upstream domain. Roles & Responsibilities: Expected to be a Subject Matter Expert (SME) with deep knowledge and experience in Oil and Gas Upstream. Should have influencing and advisory skills to guide and influence team decisions. Responsible for engaging with multiple teams and contributing to key decisions. Expected to provide solutions to problems that apply across multiple teams. Collaborate with stakeholders to understand business requirements and translate them into technical solutions. Lead the design and development of enterprise-level solutions that align with the client's business goals. Ensure the solution architecture is scalable, reliable, and secure. Provide technical guidance and mentorship to junior team members. Professional & Technical Skills: Must To Have Skills:Proficiency in Oil and Gas Upstream. Strong understanding of solution architecture principles and best practices. Experience in designing and implementing complex enterprise solutions. Knowledge of industry standards and trends in the Oil and Gas Upstream domain. Experience with cloud technologies and their application in solution architecture. Good To Have Skills:Experience with data analytics and visualization tools. Familiarity with Agile methodologies and DevOps practices. Excellent communication and presentation skills. Additional Information: The candidate should have a minimum of 15 years of experience in Oil and Gas Upstream. This position is based at our Bengaluru office. A 15 years full-time education is required. Qualifications 15 years full time education

Dear Candidate, WE ARE HIRING Department: - Production- DS Designation: - Dy Manager / Manager Qualification: - Preferably Post Graduation in Science Experience: - 15+ Years Age: - Between 35- 40Years Mandatory: - Should come in all shifts, including Night shifts Role: Shift-in-charge for entire DS floor Job Description: > Strong Functional knowledge of DS Biologics (Chromatography and related purification experience protein/ Insulin handling experience preferable). Capable of handling large teams as we have around 45 members in each shift, around 50% of contractual staff. Strong administration / team management capabilities to streamline GMP across the floor. Monitoring the efficiency of employee performance on the job. > Coordinating with other departments to ensure that production runs smoothly Ensuring that all safety regulations are followed in the production area. Managing all aspects of production, including hiring workers, ordering supplies, maintaining production schedules, and overseeing equipment maintenance. Reviewing production schedules and work orders to ensure that production goals are being met in handling QMS activities. for more details please reach out Venkat -9381915043 or please share your CV to venkateswara.k@talent21.in

Role & responsibilities Understanding business of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Understand the analytical requirements of Biologics, Biosimilars, Vaccines, fusion proteins, peptides Develop and implement strategic sales plans to achieve revenue targets within the biopharmaceutical sector. Identify and pursue new business opportunities with biopharma clients Build and maintain strong relationships with existing clients, understanding their needs and ensuring exceptional customer satisfaction. Collaborate with cross-functional teams including technical experts, marketing, and operations to tailor solutions that meet client requirements. Keep abreast of industry trends, market dynamics, and competitor activities to identify potential opportunities and threats. Prepare and deliver presentations, proposals, and contract negotiations to secure new business partnerships. Provide regular updates and reports on sales performance, market trends, and client feedback to senior management. Ability to work independently and collaboratively in a fast-paced, dynamic environment. Demonstrated ability to think strategically and execute tactical sales plans to drive revenue growth. Preferred candidate profile communication, negotiation, and presentation skills Strong understanding of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Willingness to travel as required to meet with clients and attend industry events.

To carry out routine Lab activities. To carry out assigned Lab experiments. To prepare documents as per requirements. Good knowledge of biological science. Good skills of MS Office for documents preparations.

Dear Candidate , we are hiring for Down Stream Process Executives & Operators Position . Experiance in handling the following Equipment Qualification: Bsc/Msc/ITI/B Pharmacy • M Pharmacy/Diploma/Btech/Any Degree 1 Chromatography column and system handling. 2 Column Packing (BPG And Chromoflow) 3 TFF System 4 Centrifuge system 5 Filtration, Filter Integrity,Buffer Preparation, CIP_SIP 6 Expertise in documentation QMS/GMP Compliance/Process Awareness Male Candidates & Biologics Company's only Preferable. "IMMEDIATE JOINERS ARE PREFERABLE"

Role & responsibilities The candidate should lead DP manufacturing within the Process Sciences group. The role entails utilization of the prospective candidates vast technical experience to lead a team that will be focused on manufacturing of drug product of clinical grade product quality. Specific Job Responsibilities: Strong understanding of DP unit operations like freeze/thaw, filtration, filling, lyophilization, visual inspection, leak detection and packaging. Strong understanding and provide technical leadership for manufacturing aspects for clinical DP including aseptic and compliance aspects in GMP setting. Identify best DP technologies and work with vendors to custom design filling equipment for GMP manufacturing, implementation of critical aseptic compliance aspects like control of bioburden, implementation of PUPSIT. Strong experience in commissioning isolator based DP manufacturing line, and hands on experience with qualifying line based on smoke studies, operational aspects, decontamination validation (VHP cycle development and validation) and other critical aspects. Support drug product filling line mock up review, functional design review, on site support of FAT and SAT for drug product filling line. Technical leadership for critical validation aspects of DP like media fills, filter validation, hold times, capping. Set up visual inspection program including operator training kits, qualification program. Set up packaging operations for clinical drug product supply. Provide operational expertise and leadership in managing production of clinical material in GMP setting for fill and finish, with deliverance on critical KPIs like right on time, yield and product quality. Technical leadership for troubleshooting of deviations and assess for root cause, implementation of corrective actions and assessment of product quality. Strong understanding of documentation requirements and data integrity applicable for running manufacturing operations. Strong understanding of Annex 1 requirements for aseptic processing. Work with IT and Engineering to ensure that data on manufacturing process parameters, and batch data is accessible and available in formats for data analysis. Must be focused on usage of statistical tools to evaluate process performance and process consistency. Good collaboration skills with clients Responsible for authoring and reviewing technical reports related to drug product, and contribute to regulatory submissions and audits with health agencies. Identify and communicate best practices within the CDMO function. Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development Core Competencies Drive for results Highest integrity, committed to ethics and scientific standards. Uses an approach to address the task or situation such as delegation, planning, timelines. Perseveres to find ways to work through localized challenges or barriers. Building Effective Teams Empowers team members and encourages them to contribute their skills/ideas. Gets the right talent mix for the task. Shares credit and celebrates wins. Process Management Strong organizational skills, including the ability to prioritize personal and direct reports’ workload. Abreast with the latest technical innovations and familiarity with Regulatory expectations Simplifies complex processes. Makes process improvements where value addition is relevant and important. Resourceful, uses resources and people wisely. Be data driven if providing solutions to challenges – also should have the ability to take calculated risks and manage the risks in the most transparent manner. Very good understanding and implementation of the best documentation practices including paper and electronic record keeping. Sufficient industry experience in handling cross functional interactions. Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups. Relevant Functional/Technical Skills or Industry Experience Experience in drug product operations (fill and finish) in a GMP setting is required. Experience of leading and managing a team in the bio-pharma industry is very much preferred. Strong understanding of DP unit operations like freeze-thaw, filling, filtration, mixing, lyophilization, container closure integrity testing, visual inspection and packaging operations. Strong operational expertise in running aseptic operations for drug product manufacturing, and understanding of compliance and implementation aspects around cross contamination, microbiological contamination and facility layout for GMP manufacturing. Strong experience in commissioning isolator based DP manufacturing line, and hands on experience with qualifying line based on smoke studies, operational aspects, decontamination validation (VHP cycle development and validation) and other critical aspects. Experienced in supporting drug product filling line mock up review, functional design review, on site support of FAT and SAT. Preferred to have knowledge of fill finish of complex biologics like antibodies (monoclonal, bispecifics), recombinant proteins and enzymes. Cross functional technical knowledge is highly desirable. Excellent oral and written communication and interpersonal skills will be desired. Relevant Professional / Educational Background: Masters or Ph.D in Chemical/Biochemical Engineering or similar disciplines with 12+ years of work experience in drug product development and manufacturing or B.Tech/B.E in Chemical/Biochemical engineering or similar disciplines with 14+ years of work experience in drug product development and manufacturing.

Day to day analytical activities for robust method development for peptide molecules by different techniques (HPLC and GC).Preparation of Analytical Developments Validation Protocol, process scale-up,validation of methods.Interact with customes. Required Candidate profile PhD Chemistry with 7+ years of experience in Analytical R&D in Peptide analytical method development, peptide characterization. Worked on Biotechnology, Chemical peptides and proteins related science.

Skill Required: Aseptic operation Upstream/Downstream processing Cell culture/Microbial Knowledge for MAbs/Fermentation/Protein purification Job Description: Proper execution and processing of microbial operations for all commercial, test and validation batches as per production schedule. Proper documentation of batches as per SOPs and written procedures. Ensuring compliance to cGMP in cell culture/microbial area as defined by SOPs of BBM. Preparation & revision of equipment and process related SOPs of cell culture/microbial area. Responsible for general area cleanliness, sanitation and compliance to bio safety policies of cell culture/microbial area. Learn media preparation activities of cell culture/microbial operations. Compilation of documents for the raw material and consumables used in cell culture/microbial process. Qualification of new equipments. Preparation of Qualification documents (URS, DQ, IQ, OQ and PQ). Data compilation and trend updation.

Preferred candidate profile ***Biologics experience mandatory Role & responsibilities Literature survey for Regulated and other markets drug products and other activities for complete dossier as per regulatory requirement for Formulation Development of new biological injectable formulation. Plan and monitor pre-formulation studies for biological products if needed along with innovator products characterization through subordinate scientist. Plan and monitor lab trials through subordinate scientist for formulation development of new biological injectable formulation projects as per product development timelines. To review analytical data and compile generated during different stages of formulation development of new biological products. To plan and execute along with subordinate scientist R & D scale up, plant scale up, Tech transfer batches, exhibit batches and validation batches as tech transfer activities in manufacturing location of new biological injection formulations as per regulatory requirements. To coordinate with CMOs (Contract Manufacturing Organization) for planning and executing external Tech transfer activities in manufacturing location of new biological injection formulations as per regulatory requirements. Provide technical support to production during execution of commercial validation and for any trouble shooting during production. Coordinate and support to Regulatory affairs team regarding product filing, query response and life cycle managements activities. Maintain stability record, responsible for stability data compilation and planning. Prepare of SOPs, PDR, BMR, MFR, stability protocol, stability report, process optimization protocol and report, TT protocol & Report, PV protocol & report. Monitor & maintain the store inventory for API, excipients and packaging material. Prepare and maintain of proper batch records, LNBs with all the compilation from F&D and ADL during product development. Perform activities related to new product regulatory filing and query response. Responsible to maintain good documentation practices, good lab practices and adherence to SOPs in Formulation Development Department. Perks and benefits

Job Description Position : HVAC Technician/Engineer/ Officer Pharma Vaccine Manufacturing Company : GreenSignal Bio Pharma Pvt Ltd Location : Gummidipoondi, Chennai, Tamil Nadu Employment Type: Full-Time Experience : Minimum 3+ years as an HVAC Engineer/ officer/ Technician (preferably in the pharmaceutical industry) Educational Qualification: Diploma / Bachelor's / Master’s degree in Mechanical, Electrical, HVAC, or a related field Job Summary: The HVAC Technician / Engineer/ Officer will be responsible for the installation, maintenance, and troubleshooting of HVAC systems within the pharmaceutical cleanroom environment . The role requires expertise in GMP compliance, temperature control, differential pressure monitoring, and air quality management to support vaccine manufacturing operations. Roles & Responsibilities: 1. HVAC System Installation & Preventive Maintenance Install, inspect, and maintain Air Handling Units (AHUs), chillers, cooling towers, ventilation systems, and HVAC ducting . Perform routine preventive maintenance to optimize HVAC system performance. Diagnose and troubleshoot mechanical, electrical, and airflow issues in HVAC systems. 2. Cleanroom HVAC & Contamination Control Ensure temperature, humidity, and pressure differentials meet pharmaceutical cleanroom standards. Maintain HEPA filtration systems and oversee regular filter replacements. Ensure compliance with ISO 14644 cleanroom classifications and GMP guidelines. 3. Air Distribution & Ventilation Management Maintain air distribution systems, including ducting, dampers, diffusers, and exhaust systems . Monitor and maintain fume hoods, dust extraction systems, and air showers . Ensure proper functioning of differential pressure monitoring systems for contamination control. 4. Refrigeration & Cooling Systems Maintenance Conduct regular servicing of water-cooled and air-cooled chillers . Oversee the operation and maintenance of cooling towers, condensers, and refrigeration units . Ensure compliance with energy efficiency standards and refrigerant handling protocols . 5. Compliance, Validation & Documentation Perform calibration and validation of HVAC equipment to meet GMP and regulatory requirements . Maintain detailed records of service logs, maintenance reports, and HVAC validation documents . Support internal and external audits by providing necessary HVAC system documentation. 6. Building Management System (BMS) & Automation Operate and monitor BMS-controlled HVAC systems for real-time performance tracking. Assist in troubleshooting automation systems and HVAC control units . Ensure accurate logging of HVAC parameters in the Building Management System. Key Skills & Competencies: Strong knowledge of GMP, ISO 14644, and ASHRAE standards for pharmaceutical HVAC systems. Expertise in HVAC troubleshooting, preventive maintenance, and calibration . Hands-on experience with cleanroom HVAC systems and contamination control . Ability to work effectively in a fast-paced, regulated environment . Strong problem-solving and analytical skills . Excellent teamwork and communication skills . Willingness to stay updated with industry advancements in HVAC technology. Why Join Us? Opportunity to work in a leading pharmaceutical company. Career growth in the specialized field of pharmaceutical HVAC operations. Competitive salary and benefits. Be part of a team contributing to vaccine manufacturing and healthcare innovation. About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company specializing in vaccine manufacturing . Our commitment to innovation, compliance, and operational excellence drives our success in delivering high-quality healthcare solutions. For more information, visit: www.gsbpl.com Interested candidates can apply at: hr@gsbpl.com Contact us at: 8778926365 Apply now and be a part of our team driving pharmaceutical innovations

Key Responsibilities: 1. Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. 2. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. 3. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. 4. Cross-functional Collaboration: Work closely with R&D, Clinical Development, Quality Assurance, and Manufacturing teams to support regulatory activities, resolve regulatory issues, and facilitate product development and registration. 5. Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including those set forth by regulatory authorities such as the CDSCO, FDA, EMA, and other global agencies, throughout the product lifecycle. 6. Regulatory Agency Interactions: Serve as a primary point of contact for regulatory agencies, participating in meetings, teleconferences, and regulatory inspections as needed to address inquiries and facilitate approvals. 7. Product Labelling and Promotional Material Review: Review and approve product labelling, promotional materials, and advertising to ensure compliance with regulatory requirements and company policies. 8. Regulatory Document Management: Maintain regulatory files and documentation in accordance with company procedures and regulatory standards, ensuring accessibility and traceability. 9. Risk Management: Identify potential regulatory risks and develop mitigation strategies to address them proactively, while fostering a culture of compliance within the organization. 10. Training and Development: Provide training and guidance to internal stakeholders on regulatory requirements, processes, and best practices to enhance regulatory compliance awareness and capabilities. Qualifications: Bachelor's or Master's degree in a relevant scientific discipline (e.g., biology, pharmacy, chemistry) or regulatory affairs. 9-10 years of experience in regulatory affairs or quality assurance within the biopharmaceutical industry, with specific experience in biological products preferred (rDNA). Strong knowledge of regulatory requirements and guidelines for biological products, including CDSCO, FDA, EMA, and other global regulations. Experience in preparing and submitting regulatory documents and interacting with regulatory agencies. Excellent communication, interpersonal, and problem-solving skills. Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously. Proven ability to collaborate cross-functionally and influence stakeholders at all levels of the organization