Position Overview: We are seeking a dedicated and experienced Quality Control Analyst to join our pharmaceutical team. The ideal candidate will be responsible for ensuring the highest quality standards in our analytical processes, documentation, and laboratory operations. Key Responsibilities: Analyst Qualification & Training: Oversee the qualification process for analysts. Conduct and coordinate training programs for QC employees to ensure compliance with current standards and practices. Documentation Management: Prepare and review critical documents, including Specifications, Standard Testing Procedures (STPs), Technical Data Sheets (TDS), Standard Operating Procedures (SOPs), Certificates of Analysis (COA), Method Transfer Protocols (MTP), Method Validation Protocols (MVP), Method Validation Reports (MVR), and Method Transfer Reports (MTR). Analytical Data Review: Review analytical data for routine samples, including in-process samples, Drug Substance (DS), Drug Product (DP) release, and stability samples. Oversee method transfer and method validation processes. Reference Standards & Material Management: Manage reference standards and oversee the indenting process for materials required in QC. Calibration Coordination: Coordinate with external vendors for instrument calibration. Collaborate with QC personnel for in-house calibration and verification of laboratory instruments. Laboratory Equipment Maintenance: Ensure proper maintenance and management of laboratory equipment and instruments to guarantee optimal performance. Method Validation & Transfer: Manage activities related to method validation and method transfer to ensure accurate and reliable analytical results. Quality Incident Management: Initiate and investigate incidents, deviations, change controls, Out of Specification (OOS) results, Corrective and Preventive Actions (CAPA), and Out of Trend (OOT) findings. Analysis Planning: Plan and schedule analyses for Drug Substance (DS), Drug Product (DP), stability studies, and protocol-based samples. Technical Expertise: Proficient in handling High-Performance Liquid Chromatography (HPLC) instruments, including Reverse Phase HPLC (RP-HPLC). Experience with Laboratory Information Management Systems (LIMS). Skilled in using chromatography data systems such as Chromeleon and Empower 3. Familiarity with Cation Exchange Chromatography (CEX) techniques. Qualifications: Master’s degree in Chemistry or a relevant field. Minimum of [Insert Number] years of experience in a pharmaceutical quality control laboratory. Strong understanding of cGMP, GLP, and regulatory requirements. Excellent analytical and problem-solving skills. Effective communication and teamwork abilities. Show more Show less
We're Hiring: Senior Executive / Assistant Manager - MSAT We are hiring multiple roles in Manufacturing Science and Technology (MSAT) group – Drug Product and Drug Substance 📍 Location: Chakan, Pune 📅 Experience: 5–15 years | Function: Manufacturing Science & Technology (MSAT) Are you passionate about driving innovation in biopharmaceutical manufacturing? Join Enzene Biosciences as a key member of our MSAT team—where science meets execution. What You’ll Do: 🔹 Act as the technical SME representing MSAT on cross-functional project teams 🔹 Lead change controls, deviations, and CAPAs as a change agent 🔹 Drive New Product Introduction (NPI) from checklist to batch execution 🔹 Prepare and execute PPQ/validation protocols and reports 🔹 Support CMC documentation and regulatory filings 🔹 Analyze and present process performance data 🔹 Conduct facility fit and process risk assessments 🔹 Coordinate equipment qualification activities 🔹 Act as the link between R&D / PD and manufacturing What You Bring: ✔ 5–15 years in MSAT with exposure to upstream, downstream, and/or drug product ✔ Experience in tech transfer, process validation, and regulatory documentation ✔ Strong understanding of GMP and regulatory frameworks ✔ A collaborative mindset and data-driven approach Why Enzene? At Enzene, we believe in Innovation, Respect, Candor, Excellence, Entrepreneurship, and Integrity. You’ll be part of a high-impact team working at the cutting edge of biologics manufacturing. Show more Show less
Job Title Payroll Specialist (Senior Executive / Assistant Manager) Location Chakan (Pune Plant Campus), Maharashtra, India Experience Required 10 – 12 years (hands-on, end-to-end payroll management) Workforce Focus On-roll employee strength ~600 | Role Overview We are seeking a meticulous and energetic Payroll Specialist who will own the complete payroll life cycle for our Chakan manufacturing operations. You will partner with HR, Finance and external auditors to guarantee 100 % accuracy, compliance and on-time payouts , while continuously improving processes on our HRMS platforms (Ascent & DarwinBox). Key Responsibilities Process monthly payroll for all regular employees, ensuring precision in salaries, increments, bonuses, ex-gratia and PLI calculations. Maintain & validate the personnel master database ; upload new-joiner data in Ascent and DarwinBox. Resolve employee payroll queries promptly, tracking service-level adherence. Prepare comprehensive JV postings, MIS dashboards, and payroll analytics for Finance & management reviews. Safeguard statutory compliance (PF, ESIC, PT, LWF, TDS, Form 16, etc.) and maintain documentation for internal / external / statutory audits . Conduct periodic reconciliation checks to eliminate variances and data anomalies. Collaborate with HR & Finance teams on process automation and continuous improvement projects. Desired Candidate Profile 10–12 years’ dedicated payroll experience (manufacturing / pharma / biotech preferred) MBA / MPM with bachelor’s in Accounting / Commerce Exposure to US SOX or other global compliance frameworks Certification in Payroll or Compensation & Benefits Advanced MS Excel (pivot tables, V-lookups, financial formulas) Knowledge of Power BI or other analytics tools Proven expertise in Ascent & DarwinBox (or similar HRMS platforms) Hands-on experience with RPA / payroll automation Deep understanding of Indian payroll statutes & audit preparation Prior leadership of payroll transitions or system migrations High integrity, eye for detail, strong numerical and analytical skills Lean / Six-Sigma exposure for process improvement Role Details Industry Type: Biotechnology / Pharmaceuticals / Manufacturing Department: Human Resources – Payroll & C&B Employment Type: Full-time, Permanent Work Mode: On-site (Chakan Plant) Reports To: Head – HR Operations Why Enzene Biosciences? Fast-growing biotech leader with a culture of process excellence and innovation. Opportunity to own and modernise payroll for a state-of-the-art manufacturing hub. Collaborative environment that values diversity, transparency, and career progression . Show more Show less
Hands-on execution of biopharmaceutical manufacturing processes in upstream (single-use bioreactors, media preparation systems, single-use systems) and downstream (AKTA systems, chromatography columns, UF/DF systems, buffer preparation units, virus filtration, single-use technologies). Conduct batch operations in compliance with cGMP guidelines, ensuring adherence to quality standards and regulatory requirements. Maintain and support Quality Management Systems activities including deviations, change controls, risk assessments, and CAPA implementation. Ensure compliance with Environmental Health & Safety (EHS) protocols during manufacturing operations. Collaborate effectively with cross-functional teams including QA, QC, validation, engineering, and supply chain to support smooth batch execution and issue resolution. Participate in internal and external audits, and support equipment commissioning and qualification, computer system validation (CSV), and SAP-based documentation.
Job Role: Educational qualification & Experience: Bachelor's degree in Finance, Accounting, or a related field along with CA or ICWA certification Minimum of 5-7 years of experience in finance Experience in the biotech, pharmaceutical or animal health industry is required. Strong knowledge of financial planning, analysis, and accounting principles. Demonstrated ability to manage teams and drive excellence in performance, development and growth Experience across geographies and ability to work in a high growth environment with agility is highly desirable. Proficiency in financial software and ERP systems and MS office. Excellent analytical and problem-solving skills. Strong understanding of regulatory requirements and compliance. Job Description: Implementing Process costing methodology - Track production and yields - Track consumption - Track suite occupancy - Designing suite wise hourly rate/day rate - Work out idle time - Check Standard vs Actual CoGS – Work on reducing the variances/ gaps. CMO/CDMO cost capturing, variance analysis, tracking the material usage Payback of alternate sources like media, resins Work on various variance analysis reports Calculate over/under absorption for suites / units Work on SAP report improvements - Check data accuracy - Develop / improve reports to reduce manual intervention - COPA implementation Be a core team member for strengthening the SOP’s Part of Financial planning and analysis Audit compliance - Internal Audit - Statutory Audit - Cost Audit Actively involve in procurements Inventory management - Provisioning the inventory - Working capital days tracking - Material movements including Write offs tracking Actively participate in Quarter and annual financial closures Budgeting and Forecasting (Capex & Opex) Soft skill competencies: Strong cross - functional communications, Demonstrate ability to analyze and resolve problems proactively, demonstrated ability to manage senior internal and external stakeholders Level / Designation: Senior Manager /AGM Job Location: Pune
The ideal candidate for this role should possess a Bachelor's degree in Finance, Accounting, or a related field, in addition to holding CA or ICWA certification. With a minimum of 5-7 years of experience in finance, it is essential to have a background in the biotech, pharmaceutical, or animal health industry. An in-depth understanding of financial planning, analysis, and accounting principles is crucial for this position. The successful candidate should showcase demonstrated leadership skills in managing teams to drive excellence in performance, development, and growth. Experience working across different geographies and in high-growth environments with agility is highly desirable. Proficiency in financial software, ERP systems, and MS Office is a must, along with excellent analytical and problem-solving skills. A strong understanding of regulatory requirements and compliance is also necessary. Responsibilities for this role include implementing process costing methodology, tracking production and yields, consumption, and suite occupancy. The candidate will be responsible for designing suite-wise hourly rates/day rates, working out idle time, and checking standard versus actual CoGS to reduce variances or gaps. Additionally, the role involves CMO/CDMO cost capturing, variance analysis, tracking material usage, and working on various variance analysis reports. The candidate will calculate over/under absorption for suites/units, work on SAP report improvements, check data accuracy, and develop/improve reports to reduce manual intervention, including COPA implementation. This position also involves being a core team member for strengthening SOPs, participating in financial planning and analysis, and ensuring audit compliance (internal, statutory, and cost audits). The candidate will actively participate in procurements, inventory management, including provisioning inventory, tracking working capital days, material movements, and write-offs. Quarterly and annual financial closures, budgeting, and forecasting (Capex & Opex) are also key responsibilities. Soft skill competencies required for this role include strong cross-functional communication, proactive problem analysis and resolution, and the ability to manage senior internal and external stakeholders effectively. This position is designated as Senior Manager/AGM and is based in Pune.,
Head – Supply Chain Management 📍 Location: Chakan, Pune 🏢 Company: Enzene Biosciences Ltd. 🕘 Experience: 12+ years 🌐 Industry: Biopharmaceuticals / Life Sciences About Enzene Enzene Biosciences Ltd. is a pioneering biopharmaceutical company committed to transforming healthcare through cutting-edge biotechnology. We develop and deliver high-quality biopharmaceutical products that address unmet medical needs and enhance patient outcomes. Role Summary We are looking for an experienced and strategic Head – Supply Chain to lead our procurement, sourcing, inventory, and supply operations. This critical leadership role will drive supply chain excellence and ensure seamless material availability, cost optimization, and regulatory compliance across global standards (GMP, EMA, USFDA). Key Responsibilities 1. Procurement & Strategic Sourcing Design and execute strategic sourcing plans aligned with cost, quality, and compliance goals Drive vendor evaluation, selection, negotiation, and contract management Develop supplier performance metrics and ensure adherence to SLAs Foster long-term supplier partnerships for supply resilience 2. Inventory & Materials Management Optimize inventory levels while ensuring uninterrupted material flow Collaborate with Manufacturing, R&D, and Quality to align demand and procurement Implement material planning systems to reduce waste and improve availability 3. Supply Chain Strategy & Operations Lead end-to-end SCM functions: procurement, warehousing, logistics, and distribution Implement best practices in supply planning, risk mitigation, and ERP-driven automation Champion continuous improvement initiatives to enhance operational efficiency 4. Compliance & Risk Management Ensure adherence to regulatory and quality standards (GMP, EMA, USFDA) Lead risk management strategies to address supply disruptions and ensure business continuity Qualifications Bachelor’s degree in Supply Chain, Logistics, or related field (MBA/MS preferred) Minimum 12+ years of progressive experience in Supply Chain, Procurement, or Sourcing Experience in biopharmaceuticals, biologics, or life sciences industry is highly preferred Strong understanding of regulatory requirements and operational excellence tools Why Join Us? At Enzene, you’ll work in a purpose-driven environment where innovation meets impact. Join us in shaping the future of healthcare through world-class supply chain strategies.
You will be responsible for leading the procurement, sourcing, inventory, and supply operations at Enzene Biosciences Ltd., a pioneering biopharmaceutical company committed to transforming healthcare through cutting-edge biotechnology. As the Head of Supply Chain, you will play a crucial role in driving supply chain excellence and ensuring seamless material availability, cost optimization, and regulatory compliance across global standards such as GMP, EMA, and USFDA. Your key responsibilities will include designing and executing strategic sourcing plans, driving vendor evaluation and selection, optimizing inventory levels, collaborating with cross-functional teams, and leading end-to-end supply chain functions. You will also be responsible for ensuring compliance with regulatory and quality standards, as well as implementing risk management strategies to address supply disruptions and ensure business continuity. To qualify for this role, you should have a Bachelor's degree in Supply Chain, Logistics, or a related field (MBA/MS preferred) and a minimum of 12+ years of progressive experience in Supply Chain, Procurement, or Sourcing. Experience in the biopharmaceuticals, biologics, or life sciences industry is highly preferred, along with a strong understanding of regulatory requirements and operational excellence tools. Join Enzene Biosciences Ltd. to work in a purpose-driven environment where innovation meets impact. Shape the future of healthcare through world-class supply chain strategies and make a meaningful contribution to the industry.,
🚀 We’re Hiring | Assistant General Manager – Order to Cash 🚀 Enzene Biosciences Ltd, backed by Alkem Laboratories , is an innovation-led biotech company and the only player in India with global-patented continuous biologics manufacturing expertise . With a strong pipeline in biosimilars and a rapidly growing CDMO business , Enzene is on track to become a global, modality-agnostic BioCDMO over the next few years. 📍 Location: Pune, India We are seeking an Assistant General Manager – Order to Cash (O2C) to lead our end-to-end O2C cycle across domestic and international operations. This is a senior role, reporting directly to the CFO, with the mandate to strengthen processes, compliance, and financial controls in a high-growth global environment. Key Areas of Responsibility: Lead customer & price master management, invoicing, collections, credit control, and revenue recognition Drive contract compliance, GST/indirect tax governance, and export documentation Manage cash & investment planning across India and US entities Ensure compliance with Ind AS / IFRS, FEMA, RBI, and US treasury regulations Drive digitization & automation of treasury processes (SAP Treasury) Partner with cross-functional leaders to align cash flows with business plans What We’re Looking For: ✔ Chartered Accountant (CA) or MBA – Finance from a reputed institute ✔ 6–12 years’ experience in treasury / corporate finance (biotech/pharma/manufacturing preferred) ✔ Strong grasp of financial markets, debt instruments & compliance frameworks ✔ Proficiency in SAP and Excel modeling ✔ Analytical, detail-oriented, and skilled at stakeholder management At Enzene, you will be part of a fast-growing, innovation-driven organization that is redefining biologics manufacturing globally.
We’re Hiring | Scientist / Principal Scientist / Senior Principal Scientist – Advanced Analytical Technology (AAT) 🔬 Designation subject to experience Enzene Biosciences Ltd, an innovation-led biotech company backed by Alkem , is a pioneer in continuous biologics manufacturing and a trusted partner in biosimilars and CDMO services . As part of our growth journey, we are looking for an experienced leader to join our Advanced Analytical Technology (AAT) team. 📍 Location: Pune, India Role Overview This is a senior leadership role within the AAT function, responsible for leading a team of scientists and interns, driving advanced analytical strategies, supporting CDMO projects, and ensuring high-quality scientific delivery aligned with global regulatory standards. Key Responsibilities Lead and manage a team of 6–10 scientists and interns Plan and review team work schedules, timesheets, and deliverables Represent AAT in internal governance and client meetings for CDMO projects Act as PTL (Project Technical Lead) , ensuring timely and accurate project execution Provide technical expertise in HPLC, CE, SoloVPE including troubleshooting, data review, and interpretation Contribute to method qualification (HPLC, CE, SoloVPE) Review and prepare technical documents including MQP, MOA, MQR, Specifications, Analytical Similarity Studies Support preparation of regulatory documents for EMA and USFDA submissions (analytical sections) Prepare and review client query responses and ensure timely cross-functional communication Mentor, coach, and build capabilities within the team Technical Expertise Required Advanced knowledge of HPLC-based methods : SE-HPLC, CEX-HPLC, RP-HPLC, Poly 20 measurement Expertise in Capillary Electrophoresis (CE) : CE-SDS (R & NR), cIEF; experience on Maurice system preferred SoloVPE analysis proficiency Exposure to characterization methods such as Mass Analysis, CD, Fluorescence, DSC, MALS (added advantage) Experience in regulatory documentation for global agencies (EMA, USFDA) preferred Experience & Qualification M.Sc. or PhD in relevant field 9+ years of experience in analytical sciences with demonstrated leadership in biotech/pharma Soft Skills & Competencies Fluent in English with strong presentation skills Approachable leader with team management and conflict resolution capabilities Strong cross-functional coordination skills Excellent technical data review and communication skills Ability to handle client-facing discussions confidently At Enzene, you’ll have the opportunity to work on cutting-edge biologics and contribute to shaping the future of global biotech.
Job Title: Senior Manager / Associate General Manager – Discovery Services Location: Pune Department: Discovery Research Reporting to: Head – Discovery 🏢 About Enzene Biosciences Enzene Biosciences Ltd. , a subsidiary of Alkem Laboratories , is a technology-driven biotechnology company headquartered in Chakan, Pune . Enzene is at the forefront of biologics development and manufacturing , offering end-to-end capabilities from research and process development to clinical manufacturing of biosimilars, novel biologics, and complex injectables . Enzene’s state-of-the-art facility is equipped with advanced platforms for monoclonal antibody production, ADCs, fusion proteins, and peptides. With a focus on automation, digital integration, and global compliance , we are rapidly emerging as a strategic partner for the global biopharmaceutical industry. Our Discovery Services division plays a key role in identifying and engineering first-in-class and best-in-class therapeutic molecules using advanced display technologies and AI-enabled screening platforms. 🎯 Role Overview We are seeking a passionate and accomplished scientist to lead early discovery programs focused on phage and yeast display platforms . The role requires deep technical knowledge, program leadership, and strategic collaboration to translate display-generated leads into viable therapeutic candidates. 🔬 Key Responsibilities Lead and execute phage and yeast display discovery programs for antibody and peptide therapeutics. Design high-throughput screening strategies , selection protocols, and affinity maturation campaigns. Oversee library construction (naïve, synthetic, immune) and validation with appropriate QC measures. Drive characterization and ranking of hits using biophysical and biochemical techniques. Collaborate with internal teams including Protein Sciences, Bioinformatics, Preclinical, and Regulatory . Ensure project delivery against timelines, scientific objectives, and regulatory quality expectations. Supervise and mentor a team of scientists and research associates, fostering scientific growth. Support generation of technical documentation, presentations, IP filings, and regulatory dossiers . Stay abreast of emerging display technologies, industry trends, and peer-reviewed advancements. 🎓 Required Qualifications PhD in Biotechnology, Immunology, Protein Engineering, Molecular Biology , or related field. 8–12 years of experience in the biotech/pharma industry or academia (including postdoctoral work). Proven expertise in phage and/or yeast display , including library design, selection, and optimization. Strong command of antibody structure-function , epitope mapping, and affinity maturation principles. Proficiency in molecular biology (cloning, expression), protein purification, ELISA/SPR/BLI, and FACS. Experience leading research programs and cross-functional teams. Familiarity with the biologics development pipeline , including regulatory expectations, is preferred. Strong communication, project management, and scientific documentation skills. ⭐ Preferred Skills Exposure to next-generation sequencing (NGS) for library diversity analysis. Familiarity with computational antibody design or structural modeling tools. Knowledge of alternative display systems (e.g., mammalian display , hybrid formats). Track record of scientific publications, patents, or conference presentations in relevant fields. 🚀 Why Join Enzene? Opportunity to lead innovative discovery programs in a global-scale biologics environment Work with cutting-edge platform technologies in antibody engineering and screening Collaborate with world-class scientific and operational teams in a rapidly growing biotech company Competitive compensation, supportive culture, and strong scientific leadership
You are a passionate and accomplished scientist looking to lead early discovery programs focused on phage and yeast display platforms at Enzene Biosciences Ltd. As a Senior Manager / Associate General Manager in the Discovery Services department, your role involves utilizing deep technical knowledge, program leadership, and strategic collaboration to translate display-generated leads into viable therapeutic candidates. In this role, you will lead and execute phage and yeast display discovery programs for antibody and peptide therapeutics. You will design high-throughput screening strategies, selection protocols, and affinity maturation campaigns, while overseeing library construction and validation with appropriate QC measures. Additionally, you will drive the characterization and ranking of hits using biophysical and biochemical techniques and collaborate closely with internal teams including Protein Sciences, Bioinformatics, Preclinical, and Regulatory. As a leader in this role, you will ensure project delivery against timelines, scientific objectives, and regulatory quality expectations. You will be responsible for supervising and mentoring a team of scientists and research associates, fostering their scientific growth. Supporting the generation of technical documentation, presentations, IP filings, and regulatory dossiers will also be part of your responsibilities. It is essential to stay updated on emerging display technologies, industry trends, and peer-reviewed advancements. The ideal candidate should possess a PhD in Biotechnology, Immunology, Protein Engineering, Molecular Biology, or a related field, along with 8-12 years of experience in the biotech/pharma industry or academia. Proven expertise in phage and/or yeast display, antibody structure-function, epitope mapping, and affinity maturation principles is required. Proficiency in molecular biology, protein purification, ELISA/SPR/BLI, and FACS is essential, as well as experience leading research programs and cross-functional teams. Exposure to next-generation sequencing (NGS) for library diversity analysis, computational antibody design, structural modeling tools, and alternative display systems is preferred. A track record of scientific publications, patents, or conference presentations in relevant fields is a plus. Joining Enzene Biosciences offers you the opportunity to lead innovative discovery programs in a global-scale biologics environment, work with cutting-edge platform technologies in antibody engineering and screening, and collaborate with world-class scientific and operational teams in a rapidly growing biotech company. Competitive compensation, a supportive culture, and strong scientific leadership are additional benefits of being a part of the Enzene team.,