Enzene is a technology driven company based in Pune, India. We strive to harness disruptive innovation to enhance global health. Our aim is to provide, affordable, quality medicine for aiding lives with debilitating conditions. Enzene has invested in world class R&D infrastructure which allow access to technologies of the future. Enzene has end to end development platform from our own propriety CHO duos cell lines, to high throughput upstream and downstream platforms, comprehensive drug product development capabilities backed by state of the art advanced analytical technologies supports speedy development of pre-clinical and clinical drug candidates.
Walk in Drive at Hyderabad Quality Assurance
Experience : 4 to 12 Years
Qualification : M.Sc/M.Tech/M.Pharm (Biotech, Bioprocess Technology, Life science)
Job Description
Vendor Management
Vendor Management, Contract testing laboratories qualification, Qualification and management of contract vendors and external service providers, QMS and compliance.
Validation QA
• Knowledge of Shipping validation activity for cold chain products.
• Responsible for review of Validation protocol and report such as URS, DQ, IQ, OQ and PQ.
• Role holder will be responsible for Equipment Validation and qualification of pharmaceutical sterile facility
Training & Development
• Responsible for designing, implementing, and overseeing the organization's training and development programs.
• Enhancing employee skills, ensuring compliance with industry standards, and supporting organizational growth through effective training strategies.
• Work closely with various departments to identify training needs, develop training materials, and evaluate the effectiveness of training programs
Bio-Bulk Manufacturing (Drug Substance)
Skills/Technical :
• Mammalian and Microbial (Upstream Process): Media preparation, Filtration, Aseptic technique, Inoculum Handling, Handling of SU bioreactor/RM, Perfusion technology, upstream analytical instruments. Handling of SS Fermenter, Continuous centrifuge
• Mammalian and Microbial (Downstream Process): Buffer preparation, Filtration Technique, SU Technology, Batch/Continuous chromatography Column packing, TFF technique.
Upstream Process Development (UPD)
Skills/Technical : Mammalian and Microbial (Upstream Process):
• Mammalian: Handling of AMBR250, Expertise in perfusion technology, Media preparation, media and feed optimization at SF, Expertise in DOE and process characterization
• Microbial: Handling of 5L-50L Fermenter, expertise in process optimization, DOE and process characterization
Advance Analytical Technique (AAT)
Skills/Technical : • Knowledge of analytical method development, method qualification and method transfer
• Understanding of analytical instruments : HPLC, UPLC, SoloVPE, Maurice, DSC, CD, Plate reader
• Drafting /Reviewing of documents such as the specification, justification for the specification, MOA, SSR, SSP, MVP, and MQR.
Method Validation Lab (Quality)
Skills/Technical : • To perform method validation, stability sample analysis and review of analytical data.
• Preparation and review of Documents (Specification, STPs, TDS, SOP, COA, MVP, MVR MTR etc.)
• Coordination with vendor for external calibration and with QC personal for in-house calibration and verification of laboratory instruments and equipment.
Downstream Process Development (DSP/PPD)
Skills/Technical : • Hands on experience in development of protein purification unit operations (like Chromatography, Depth filtration, UFDF, refolding, conjugation reactions, etc.) for mammalian/microbial expressed antibodies and/therapeutic proteins.
• Candidate should have awareness about principles of Scale up and scale-down model qualification, process characterization (PC) based on DOE approach, statistical analysis of PC data, technology transfer activities, troubleshooting of process during manufacturing, continuous process, etc.
• Drafting /Reviewing of documents such as the study protocols, reports, BMRTTD documents, etc.
• Involve in functional supportive activities like equipment maintenance, calibration, compliance, etc.
Drug Product Development (DPD)
Skills/Technical : • Hands on experience in liquid and lyophilized formulation development of therapeutic proteins like MAbsand other bispecific proteins.
• Able to design and execute support studies for DP mfg process like, filter, tubing, CCS compatibility studies, etc. and on DP like agitation, TOR, temp excursion studies, etc.
• Candidate having knowledge about combination product development for pens and auto-injector with regulatory requirements for the same will be added advantage. Knowledge about scaling up and down of dp formulation mfg process is preferable.
• Drafting /Reviewing of documents such as the study protocols, reports, BMRTTD documents, etc.
Quality Management System (QMS) - Quality Assurance (QA)
Skills/Technical : • Experience in performing investigations by utilizing investigation tool.
• Managing and tracking deviations, CAPA, and change control.
• Experience with document management systems.
• Understanding of regulatory guidelines like USFDA, EMA, etc.
• Experience in validation and qualification lifecycle management.
• Experience in data integrity and data governance.
In Process Quality Assurance (IPQA)
Skills/Technical : • Online review of BMR during batch manufacturing.
• Stage specific line clearance for critical activities.
• Oversight on sampling and shop floor compliance round the shift.
• Review of Master documents and executed documents.
• Batch Release.
• APQR preparation.
• Shop floor investigation.
• Review of facility related documents i.e. Risk Assessment, Protocols, Reports, SOP's.
• Coordination with client for investigation report review and finalization.
Analytical Quality Assurance (AQA)
Skills/Technical : • Stability Management - Stability charging and pullout, Stability protocol and report preparation, Stability data review, SAR and SSR preparation and review, Stability chamber maintenance.
• Analytical/Bioassay Data Reviewer - In process and release data review, Audit trail of release data, COA review, STP and spec review.
• Microbial Data Reviewer- In process and release data review, Audit trail of release data, Method validation data review for micro
Quality Control Analyst and Reviewer (QC Analytical)
Skills / Technical : • Analyst : Knowledge of GMP, GLP, DI and GDP, Experience and proficiency in the tasks such CEX-HPLC, SE-HPLC, ELISA and Capillary Electrophoresis analysis, perform analysis and review of analytical data for routine samples (In-process samples, Drug substances, Drug product release and stability samples), method transfer and method validation, Preparation and review of Documents (Specification, STPs, TDS, SOP, COA, MVP, MVR MTRetc.)
• Reviewer : Knowledge about GMP, GLP and GDP, Well versed in empower and chromaleon software data review and trouble shooting, Preparation and Review of documents for installation, calibration, qualification and verification of laboratory instruments and equipment. Preparation and Review of documents such as SOPs, Specifications, STPs, TDS, protocol and reports for reference standard qualification, protocol and reports for stability study Etc, Investigation report preparation and review of 00S, 00T and deviations. To recommended and review the CAPA, change controls.
Domestic Regulatory Affairs- (Domestic-RA)
Skills / Technical : • Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologies, Biosimilar, Novel Biologies 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.).
• Good knowledge of the regulatory product maintenance process
Global Regulatory Affairs (Global- RA)
Skills / Technical : • Drafting and review of the eCTD sections for regulated market such Europe, USA, Canada, Brazil etc for biological products (Biosimilars).
• Preparation of the briefing book for scientific advice, for EMA, UK HMRA etc.
• Collation of the modules for BLA/NDA/EU MAA etc
• Sequence prapatration and publishing activity for regulated market using eCTD software.
• Should be capable to devise the strategy of the eCTD filing as well as developmental requirements of the
• Biosimilar proteins, synthetic proteins and new entities
• Should be aware of the regulatory requirements of Ml to M5 structure of different countries
Walk in Interview
Date : Sunday, 25th August 2024
Time : 9:30 AM - 6:00 PM
Address : Hotel Green Park, Greenland, Begumpet, Hyderabad - 16
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