Role & responsibilities : Person would be team leader. Person would be responsible for managing 6-10 people from sr. scientist to interns. Candidate would be responsible for planning of work for direct reportees, reviewing of their timesheets. Candidate would be responsible for coordination with cross functional team and AAT team. Person would be responsible for representing AAT in internal meetings Person should be experienced for HPLC, CE, SoloVPE related techniques, trouble shooting , data review and data interpretation Knowledge in characterization methods such as Mass analysis, CD, Flr, DSC, MALS would be an additional advantage. Person should know method qualification for HPLC, CE, SoloVPE related techniques Person would be involved in document preparation and review of MQP, MOA, MQR, Specification, analytical similairty studies Experience in analytical section related sourced document preparation for EMA and USFDA would be an additional advantage Person would be responsible for preparaing client query response and timely communication to cross functional team Technical Skill Requirement: Knowledge for HPLC based methods such as SE HPLC, CEX HPLC, Poly 20 measurement, RP HPLC, Capillary Electrophoresis related based techniques such as CE SDS R & NR, cIEF. CE analysis on Maurice system would be an added advantage SoloVPE analysis Soft Skill Requirement: Fluent in English, Should be approachable Able to present technical data in internal meeting Able to faciliate required work by coordinating with cross funcational team Technical review of the the data and ensuring timely communication to cross funcational team Able to resolve/disucss with manager if any conflicts within team is oberved
Role & responsibilities 1.Responsible for work planning and review of documents related to In process, DS, DP, stability testing, AMV and AMT activities within quality control laboratory. 2. To effectively plan and monitor shift duties of the QC analytical staff members to support 24*7 business operations. 3. Responsible for compliance to internal, external & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines. 4. Responsible for periodic training management related to quality, GMP, regulatory aspects to quality control laboratory personnels and evaluation of effectiveness. 5. Responsible for the periodic assessments/audits to identify gaps / improvement opportunities for strengthening the quality & regulatory compliance. Prepare remediation/mitigation plan (CAPA) and execute it in a timely manner by coordinating cross functionally to uplift the level of compliance’s. 6. Responsible for review and approval of documentation such as SOP’s, Specifications, STP’s, TDS, reports for IRS analyst qualification, protocols, Qualifications and reports etc. 7. Responsible for investigations and approval of OOS, OOT and deviations. To recommend and approve CAPA, change controls. 8. To release or reject the samples handled in quality control laboratory.
Role & responsibilities • Design and execute media/feed screenings and optimizations using ambr250 and bioreactor culture • development, including fed batch and perfusion cell culture processes. • Planning, assigning, and supervising daily operations to ensure proper experiment execution • Experience with aseptic techniques, cell culture in various lab-scale formats, small to medium scale • bioreactors, and cell counting methods and equipments like Cedex, Vi Cell, Osmometer • Handling of Mammalian cell culture using bench top, single use bioreactor and high throughput • systems such as ambr250, WAVE bioreactors and ATF systems. • Excellence in cell culture process development by Fed batch as well as Perfusion process. • Bioreactor culture development including fed-batch, N-stage perfusion technologies (2 to 50L scale) • with both glass and single-use cell culture technologies • Daily review of ongoing experimental data • Reviewing functional PDR, TTD etc. • Good interpersonal, verbal and written communication skills. • Excellent communication and presentation skills and aptitude for problem solving • Act as an effective and committed team player Experience & Qualification:- 1. 9 to 15 years of experience with M.Tech/M.Sc. degree in biotechnology/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline. 2. Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace and dynamic team setting.
Job Description: Planning and execution of Downstream Process activities for mammalian and/or microbial products/recombinant protein under the supervision of the manager. Responsible for ground level planning, execution, data capturing, compilation, and interpretation in coordination with the Associate scientist/Scientist. Drafting of presentation and discussion with the manager. Presenting data in internal meetings as functional lead. Responsible for documentation activities like preparation of development reports, BPR, SOP, EOP, IOP. Participate in planning and decision-making discussions regarding activity priorities, providing information on the feasibility of prospective projects to the reporting manager. Supporting in troubleshooting of technical problems at manufacturing by discussion and execution. Candidate will be responsible for lab management activities (Maintaining lab cleanliness, equipment maintenance). Cross-functional communication with internal and external vendors/clients for technical queries in consultation with the manager. The candidate will be responsible for maintaining environment, health, and safety (EHS) requirements at the workplace to ensure individual and lab/plant safety. Technical Skill Requirement: Protein purification process development expertise (Chromatography, Depth filtration, Centrifugation, UFDF, sterile filtration, etc.) in mammalian/microbial expressed antibodies and/or therapeutic proteins. Execution and monitoring of processes to ensure consistency and reliability. Awareness about Process Development using DoE approach and Quality by Design (QbD) will have added advantage. Scale up/Down, technology transfer activities. Responsible for setup, operation, troubleshooting, and routine maintenance of purification equipment (Chromatography system, pH/conductivity meter, UFDF system, etc.). Strong commitment and dedication towards work, enthusiasm, motivation, and persuasive ability in a team. Work independently, analyze and interpret experimental data, and present/document experimental results at meetings. Proficiency or awareness in protein analytical techniques (e.g., protein assay, gel electrophoresis, HPLC, etc.) is an added advantage. Willingness to work in a dynamic environment with a stringent timeline. Soft Skill Requirement: Strong written and communication skills. Team player.
Regulatory Affairs Management- Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. Provides regulatory input on procedural and documentation requirements as defined by Health Authorities such as Indian regulatory authority, Emerging markets and ROW countries. Review of documents (e.g. RCGM-PCS, CTA, MAA, PAC, response documents, study protocols, regulatory maintenance documents, PSURs, etc.). Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions. Liaises closely with cross-functional members with aligned product responsibilities. Develops, completes and maintains submission delivery plans, submission content plans, and proactively provides status updates of the ongoing projects within the organization. Coordinates the input, maintenance and revision in the project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to function head. Supports operational team and Project team w.r.t to regulatory requirements. Provides coaching, mentoring and knowledge sharing within the team. Contributes to process improvement. Minimum Requirements Education and Experience Relevant University Degree in Science or related field Minimum 10-16 years of relevant Regulatory experience within the biopharmaceutical industry, including experience in CTA, MAA, PAC and ROW markets for Biological and Biosimilar products and general knowledge of drug development Good knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams. Preferred Experience Regulatory affairs experience across a broad range of markets. Having experience in Regulatory information management system Handled regulatory deliverables at the project level Experience of working with people from locations outside of India, for Emerging and ROW markets. Skills and Capabilities Excellent English written and verbal communication skills Cultural awareness Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions Proficiency with common project management (e.g., MS Project) and document management tools Ability to work independently and as part of a team Influencing and collaborator management skills Ability to analyse problems and recommend actions Continuous Improvement and knowledge sharing focused Operations/Manufacturing organisation (CMC post approval) Marketing Companies/Local affiliates Reporting Relationship Direct Reports – 2-4
Role & responsibilities Serve as the primary subject matter expert for all bioanalytical methods, including method development, validation, and sample analysis. Design and execute complex experiments for the quantification of drug candidates, metabolites, and biomarkers in biological matrices using a variety of platforms (e.g., Ligand Binding Assays, cell-based functional assays). Lead the evaluation, implementation, and troubleshooting of new analytical platforms and technologies to advance the laboratory's capabilities. Develop and influence bioanalytical strategies for multiple projects across the drug development pipeline. Manage project timelines and resources, serving as the bioanalytical representative for cross-functional project teams. Interact with internal and external partners, including Contract Research Organizations (CROs), to ensure project and scientific needs are met. Ensure all bioanalytical work is in compliance with relevant regulatory standards, including GLP, GCP, and ICH guidelines. Author, review, and approve critical regulatory documents, protocols, validation reports, and standard operating procedures (SOPs). Function as a key technical resource during regulatory inspections and client audits. Supervise, train, and mentor junior and senior scientists, fostering an environment of scientific excellence and professional development. Prioritize and schedule the workload of direct reports to meet project deadlines. Provide regular performance feedback and conduct annual reviews for team members. Present data, project updates, and scientific strategy to project teams, senior management, and clients. Contribute to scientific publications, presentations at conferences, and patent applications. Experience: Extensive, hands-on experience in bioanalytical method development, validation, and sample analysis within a regulated environment (GLP, GCP). Proven expertise with analytical techniques, including LC-MS/MS and Ligand Binding Assays (e.g., ELISA, MSD, Luminex). Experience with a variety of matrices such as plasma, serum, urine, and tissues. Demonstrated experience in leading projects, managing scientific staff, and fostering a collaborative team environment. Skills and Competencies: Exceptional problem-solving, troubleshooting, and analytical skills. Strong strategic and critical thinking abilities. Excellent written and verbal communication, and presentation skills. Proficiency with relevant software for data acquisition and analysis (e.g., Analyst, Softmax, LIMS). Deep knowledge of regulatory guidelines and industry best practices. Effective leadership and mentoring capabilities.
Position Summary: The Executive Regulatory Affairs (Biosimilars) will be responsible for the preparation, review, and submission of high-quality CMC documentation to support regulatory filings in the US, Europe, and other global markets. The role involves cross-functional collaboration, drafting of eCTD modules, and ensuring compliance with international regulatory requirements for biosimilar products. Role & responsibilities Review and finalize CMC (Chemistry, Manufacturing, and Controls) documents for US (FDA) and European (EMA) regulatory submissions. Draft, compile, and review eCTD sections , ensuring compliance with current regulatory and technical standards. Author and review key regulatory documents , including INDs, IMPDs, and Briefing Books (BBs) . Collaborate effectively with cross-functional teams (CFTs) such as Quality, Manufacturing, Analytical, and Clinical to gather required information and align on submission strategy. Ensure the use of appropriate regulatory language and consistency across all submission documents. Ensure documents meet PDF publishing and technical property requirements for eCTD submissions. Maintain up-to-date knowledge of ICH guidelines , regional regulatory frameworks , and biosimilar-specific requirements . Support regulatory strategy development and responses to health authority queries as needed Qualifications and Experience: Masters degree in Pharmacy, Biotechnology, Life Sciences, or a related discipline. Minimum 3 years of experience in CMC regulatory affairs with a focus on biosimilars . Hands-on experience with IND, IMPD, and eCTD submissions . Strong understanding of ICH and regional regulatory requirements for biosimilar development and registration. Proficiency with electronic publishing tools and eCTD document standards . Excellent communication, coordination, and documentation skills . Strong attention to detail, regulatory writing, and analytical skills.
Role & responsibilities: 1.Shall be responsible for overall operations and maintenance of the plant and utility machinery. 2. Should have hands on experience in operation and maintenance of Biotech Process Equipment like Fermenters, Bioreactor, Centrifuge, Homogenizer, Lyophilizer, Chromatography columns, Autoclave, Cold room, QC equipment, HVAC, Water system etc. 3. Should have basic understandings of electrical and instrumentation troubleshooting. Should have knowledge about Energy Management / Conservation. 4. Should have exposure to regulatory audits and compliance. 5. Preparation & revision of SOPs and QMS documentation. Maintaining equipment logbooks, PM planner & records. Responsible for Utility related QMS, audit observations and compliance. 6. Training of contract employees/ operators, assigning shift activities and ensure to get completed. 7. Should have handled gas banking system like O2, CO2, N2 & Argon. Safety regulations should be known. 8. Willing to work in extended hours as and when required. 9. Ensure to attend breakdown maintenance calls and keep equipment ready for production. Carry out Preventive Maintenance as per schedule and maintain equipment in healthy condition. 10. Responsible for all process equipment critical spare identification, procurement and its management. 11. Should have knowledge of Clean room paneling work, utility/process piping etc. Shall be responsible for facility maintenance. 12. Responsible for planning and execution of yearly Power & Boiler shutdown for yearly statutory passing.
Role & responsibilities: 1. Lead investigations into quality incidents, deviations, and non-conformances within our manufacturing processes. 2. Conduct thorough root cause analyses to identify the underlying causes of quality issues and develop effective corrective and preventive actions (CAPAs). 3. Collaborate closely with cross-functional teams, including production, engineering, and quality control, to drive investigations to resolution. 4. Utilize scientific and statistical methodologies to support investigations and determine appropriate corrective actions. 5. Provide technical expertise and guidance to junior investigators and ensure investigations are conducted in compliance with regulatory requirements and company policies. 6. Develop and implement strategies to prevent recurrence of quality incidents, leveraging best practices and industry standards. 7. Monitor and report on investigation progress, ensuring timely completion and documentation of investigation activities. 8. Continuously improve investigation processes, tools, and systems to enhance efficiency and effectiveness. Preferred candidate profile: 1. Proven experience in a manufacturing or MSAT role within the pharmaceutical or biotechnology industry. 2. Demonstrated expertise in conducting investigations, root cause analysis, and implementing effective CAPAs. 3. Thorough understanding of Quality Management Systems (QMS) and regulatory requirements, including FDA guidelines and cGMP. 4. Strong analytical and problem-solving skills, with the ability to apply scientific methodologies to complex quality issues. 5. Excellent communication and interpersonal skills to collaborate with multidisciplinary teams and effectively communicate investigation findings and recommendations.
Roles & Responsibilities: Microbiological Risk Management: Identify, assess, and control microbiological risks in raw materials, production processes, utilities, and finished products. Develop and implement effective control strategies. Laboratory Operations Management: Lead and oversee all microbiology laboratory activities including: Routine testing of raw materials, in-process, and finished products. Method validation/verification and equipment qualification. Cleaning validation and environmental monitoring (EMPQ). Microbial identification and trending of environmental monitoring results. Technical Problem Solving: Investigate and resolve laboratory technical issues, out-of-specification (OOS) results, and environmental monitoring (EM) nonconformances. Drive root cause analysis and implement effective CAPAs. Team Leadership & Training: Supervise, mentor, and train microbiologists and lab technicians. Foster a culture of continuous learning and ensure adherence to microbiological best practices. Regulatory Compliance: Ensure all microbiology operations comply with cGMP, regulatory, and corporate quality standards. Manage deviations, change controls, and CAPAs within the Microbiology function. Documentation & Reporting: Prepare, review, and update SOPs, protocols, and reports related to microbiological activities. Maintain robust documentation practices aligned with audit readiness. Data Management & Analysis: Oversee data recording, management, and storage systems (LIMS preferred). Ensure accuracy, traceability, and accessibility of microbiological data. Analyze trends to identify process improvements and contamination risks. Audit & Client Interaction: Act as a subject matter expert (SME) for microbiology during regulatory inspections and client audits (including USFDA, MHRA, etc.). Prepare audit responses and ensure compliance readiness. Preferred Candidate Profile: Strong exposure to sterile microbiology in a pharmaceutical manufacturing environment (Injectables / Parenterals). Hands-on experience in facing USFDA audits and handling audit queries independently. Proven experience in Contamination Control Strategy (CCS) implementation for sterile areas. Sound understanding of GMP, GLP, and regulatory requirements for sterile product manufacturing. Excellent leadership, analytical, and communication skills. Education & Experience: Qualification: M.Sc. / M.Tech in Microbiology, Biotechnology, or related field. Experience: 15-21 years in sterile pharmaceutical microbiology with leadership exposure.
Role & responsibilities IT - IT Operations Design and implementation of enterprise and data center wide data network solutions that align with the architecture and business models to achieve optimal solutions for Enzene and its clients. Developing, implementing, and maintaining network solutions to include Network, Network Security/Threat, and Voice solutions; developing and maintaining network documentation; Developing and maintaining network standards and guidelines; Manage network and security capacity planning; network and network security lifecycle management, interacting and consulting with Enzene clients (internal and external) to collect required solution information; Provides high level design, implementation, and troubleshooting support for infrastructure hardware / software. Performs key role in implementation and maintenance planning. Demonstrates advanced proficiency within infrastructure related requirements and configurations. Operates under minimal supervision, with latitude for decision making and cross-team communication. Network traffic and security management and trouble shooting. Technical Experience: Network experience Hands-on technical experience on Network Convergence / Transformation projects involving integration of Core Data Network, Ability to design, configure and implement Routing and Switching technologies, MPLS/SD-WAN, Network Security, Data Center networks firewalls(Fortinet), IDS/IPS, VPN, load balancers, WAAS/ WAF and Proxy. In depth knowledge of IP addressing, subnetting, routing protocols Multicast, VPLS and VPRN.
Role & responsibilities Quality Documentation & Compliance: Handling and preparation of GMP-related documents including Change Controls, Deviations, OOS, CAPA, Lab Incidents, APQR, and Investigations, with diligent follow-up to ensure timely closure. Document Management: Management and handling of Cell Bank documentation and Technology Transfer documents to support regulatory and operational compliance. Validation & Review Activities: Review of Process Validation and Cleaning Validation protocols and reports, Batch Manufacturing Records (BMR), and Continued Process Verification (CPV) data to ensure accuracy and alignment with regulatory expectations. CPV & PQR Analysis: Handling of JMP software for statistical analysis and reporting of CPV and Product Quality Review (PQR) data. Internal Audits & GMP Compliance: Execution and monitoring of Internal Audit programs to uphold Good Manufacturing Practices (GMP) and drive continuous quality improvement across the organization. IPQA & Shop Floor Oversight: In-process Quality Assurance (IPQA) oversight including shop floor investigations to ensure compliance during manufacturing operations. Team & QA Engagement Management: Coordination and management of QA team activities, ensuring effective execution of quality systems and engagement in cross-functional initiatives Preferred candidate profile Experience - Between 9 to 12 years Qualification - M.Sc or M.Pharm
Key Responsibilities: Project planning, Gantt Preparation and timeline tracking. Risk management: Identify project issues early on and facilitate resolution, work on risk mitigation plans and/or timely escalations Managing across multiple workstreams to ensure dependencies and milestone delivery. Effective stakeholder/cross-functional team management (including external clients) Own Budget, scope and timeline for projects. Monitor project plans with time and cost variance analysis Ensure vital communication within the teams (meetings, minutes, action items, follow-ups) Effective change management and facilitate necessary approvals Co-ordinate with Finance/Regulatory for submission of required documentation Dashboard and progress report preparations (monthly, quarterly Maintain key learning repository and implementation in new project Training of interns and Project coordinators. Assist in the establishment of PM best practices/tools and systems in order to enhance efficiencies within the organization Skills Background in managing/delivering projects preferably related to Biologics/Biosimilars etc. Effective communication and presentation skills with good written & spoken English Proficiency in SAP operation and other PM tools (Smartsheet, Excel and other MS Office applications). Understanding of MS Project would be a plus. Foster teamwork, conflict resolution (manage and build relationships to drive project delivery) Strong team leadership skills Qualification & Experience: MSc (Life Sciences), M.Pharm., MBA Any basic project management certification (not mandatory) Experience: 10- 14 Years
Role & responsibilities Drive the successful delivery of the production plan for mammalian Drug Substance (DS) manufacturing in alignment with organizational goals. Take full ownership of end-to-end Cell Culture processes, ensuring adherence to operational excellence and performance KPIs. Lead, mentor, and develop the Cell Culture operations team, fostering high performance, technical competency, and continuous improvement. Maintain effective financial control over all operational expenses related to mammalian DS manufacturing, ensuring budget compliance and cost efficiency. Ensure robust Continuous Process Monitoring (CPM) of validated processes, analyze trends, and drive process optimization and improvement initiatives. Perform and support root cause investigations for process deviations, OOTs, CAPAs, and operational issues, ensuring timely closure and preventive measures. Proactively identify and evaluate technical challenges in Upstream or Downstream operations and provide effective solutions. Collaborate efficiently with cross-functional teams including R&D, MSAT, QA, QC, Supply Chain, and Regulatory Affairs to ensure seamless coordination and compliance.
Role & responsibilities 1. Should have hands on experience in Maintenance of DS equipment such as Bioreactors, Centrifuge, Homogenizer, Autoclave, Lyophilizer, Stability chambers, Cold room, modification project handling which includes CRP, HVAC, Clean room, MEP, Water system, Process Equipment etc. 2. SME for Plant Maintenance and Facility during audits. 3. Should have in depth knowledge of DP equipment operation and Maintenance. This includes PFS, Cartridge, Vial Filling machine, Packing machine. Should be able to plan Preventive maintenance and area qualification activities as per defined schedule. 4. Motivate & direct the team to work towards the organizational goals. 5. Preparation of QMS like Risk assessment, Impact assessment, Investigation, Qualification protocols, SOP etc. 6. Training of contract employees/ operators, assigning shift activities and ensure to get completed. 7. Should have knowledge of Clean room, CRP facility, process piping, Utility piping, flow calculations etc. 8. Should have experience to work and deal with CFT. 9. Responsible for Engineering stores. Keep record of spares list, inventory and maintain critical spares as well material receipt and issuance. 10. Responsible for raising request for procurement and its follow up. Doing SAP entries, bills regularization etc.
Role & responsibilities 1. Should have experience in Pharma & Biotech projects as well Operation/Maintenance of Clean Utilities like HVAC & Water system. 2. Should have experience in project handling which includes CRP, HVAC, Clean room, MEP, Water system, Process Equipment etc. He will be SME for clean Utilities during audits. 3. Should have in depth knowledge of HVAC & Water system operation and Maintenance. Should be able to plan Preventive maintenance, Sanitization, Filter Cleaning as per defined schedule. 4. GMP knowledge, SOP preparation, Qualification documents preparation, QMS knowledge. 5. Should have exposure to major Regulatory audits like USFDA, EMA, TGA, ANVISA, etc. 6. Should have experience to work and deal with design consultants. Getting design updates, review and revise. 7. Preparation of micro planner related to projects along with bottlenecks. 8. Training of contract employees/ operators, assigning shift activities and ensure to get completed. 9.Should have knowledge of process piping, Utility piping, flow calculations etc. 10. Willing to work in all three shift on rotation basis as and when required. 11. Responsible for project stores. Keep record of all project material receipt and issuance. 12. To follow site Safety regulations and manage work permits to site contractors. 13. Responsible for planning and execution of project activities 14. Should have knowledge of AutoCAD. Should have to prepare plant layouts & drawings, Utility P&ID etc. 15. Should have knowledge about Energy Management / Conservation.
Role & responsibilities Oversee and manage the entire packing operations, ensuring smooth functioning of all packing lines and adherence to production schedules. Lead, supervise, and coordinate the activities of the packing team, ensuring efficient packaging of products in compliance with quality and regulatory standards. Monitor packing operations closely and conduct inspections of packaging materials, containers, and finished goods to ensure conformance to specifications and GMP requirements. Review, approve, and update Packaging Work Order Instructions, SOPs, Batch Packaging Records (BPRs), and other relevant documents. Coordinate effectively with Production, QA, QC, Engineering, Warehouse, and Supply Chain teams to meet daily operational targets. Ensure proper operation, adjustment, and minor troubleshooting of packing machinery; coordinate with the Engineering department for major repairs or maintenance needs. Plan manpower deployment, provide training to workers/operators on equipment operation, GMP practices, and safety requirements. Prepare and review assembly protocols, equipment operation protocols, line clearance documentation, and other required operational records. Monitor and control packing material consumption and maintain accurate inventory records of materials and consumables. Implement continuous improvement initiatives in packing processes to enhance efficiency, reduce downtime, and minimize wastage. Ensure compliance with safety guidelines, regulatory requirements, and internal quality standards.
Role & responsibilities : Assay Development & Execution: Perform method development, method qualification, and sample analysis for SPR, BLI, cell-based assays, and ELISA. Independently design, execute, and troubleshoot assay protocols. Ensure timely completion of all analytical activities with high scientific quality. Documentation & Reporting: Prepare and review technical documents including dMOA, MQP, MQR, MTP , and other assay-related reports. Maintain accurate, complete, and compliant records following Good Documentation Practices (GDP) . Contribute to data interpretation, documentation, and presentation of results. Equipment Management: Perform routine preventive maintenance (PM) and calibration of laboratory equipment. Ensure instruments are in optimal condition and maintain proper usage logs. Coordinate with service engineers for repairs and troubleshooting when needed. Compliance & Quality: Adhere to all lab safety guidelines , SOPs, GDP, and quality systems. Support audit readiness and contribute to continuous process improvements Qualifications & Skills Masters degree in Biotechnology, Biochemistry, or related life science discipline. 5-8 years of hands-on experience in SPR, BLI, ELISA, and cell-based assays . Strong understanding of assay development, qualification, and validation principles. Proficiency in scientific writing and technical document preparation. Good analytical skills, attention to detail, and ability to work independently as well as in a team.
Role & responsibilities : Execution support in formulation development for liquid/lyophilized protein formulation Execution of Lyophilization cycle development Execution of Product and process development studies (product contact part compatibility, hold time, freeze thaw, thermal cycling study, agitation study, Photostability study, temperature excursion study, In-use study, reconstitution solution stability study, preservative efficacy) Execution of Product and process characterization studies Preparation of scientific documents like protocol, report, BMR, TTD, MOA Execution of subvisible particles testing using different techniques (MFI, HIAC) Execution of functional performance testing using UTM Preparation of pharmaceutical development report Strong data interpretation and troubleshooting skills Understanding about E&L study, Nitrosamine and Elemental impurity testing Sound cross functional communication skills, interpersonal skills Hands-on experience on Aseptic formulation and filling operation, Lyophlizer, Densitometer, Viscometer, Osmometer, Micro flow imaging, Light obscuration particle count testing (HIAC), UFDF system. Execution support in formulation development for liqu id/lyophilized protein formulation
Enzene Biosciences Ltd is hiring for CA Freshers! Job Title: Management Trainee Finance Department: Finance Location: Pune Reporting To: GM Finance & Above About Enzene Biosciences Ltd We Are Enzene, a Continuously Innovative Development and Manufacturing (CIDMO) partner to innovators and biosimilar developers. From state-of-the-art sites in Pune, India, and Hopewell, New Jersey, we provide fully-integrated services that span discovery, development, and commercial supply. Our innovative EnzeneX platform incorporates the first truly fully-connected continuous manufacturing (FCCM™) technology to be validated for commercial biologics supply. We are proud pioneers of next-generation biologics technologies, and disruptors of existing biologics manufacturing paradigms: accelerating time-to-market and providing the highest production yields to drive down the cost of a broad range of biologic modalities. For more information on Enzene, please visit www.enzene.com Role Overview As a Management Trainee in Finance , you will gain structured exposure across key finance domains - Taxation , Manufacturing Finance , and Financial Planning & Analysis (FP&A) . The role is designed to groom you into a future finance leader capable of supporting a fast-growing global biotech organization. Key Responsibilities Role 1 - Taxation & Compliance Ensure timely compliance with Direct Tax (Income Tax, TDS) and Indirect Tax (GST) requirements. Support in transfer pricing documentation and international tax matters. Assist in tax audits, reconciliations, and risk mitigation initiatives. Role 2 - Manufacturing Finance Partner with plant teams to monitor production costs, yield analysis, and inventory valuation. Support cost optimization projects and CAPEX evaluations. Ensure robust internal controls and compliance with SOPs. Role 3 - FP&A Assist in preparation of annual budgets, forecasts, and variance analysis. Support monthly MIS reporting and performance dashboards for leadership. Analyze cost drivers and contribute to strategic decision-making. Soft Skill Competencies: High learning agility and ability to deal with complexity. Strong attention to detail and analytical mindset. Effective communication and stakeholder management. Ability to work independently and in cross-functional teams. Education & Experience CA Fresher Why Join Us? Work with India's most advanced biologics tech platform Exposure to global finance practices Fast-track growth and development Opportunity to contribute to a rapidly scaling, innovation-led biotech company