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WE ARE HIRING!
The world needs new energy, like yours

Our work is making a global impact. Join our team for pursuing next-generation protein expression challenges.

Process Development Lab Team Lead

10+years; Manesar, Gurgaon

Position
Team Lead - PDL

Required Experience
M.Sc/ M.Tech/ ME/PhD in Biochemistry/ Biotechnology with 10+ years of relevant work experience in Biopharmaceutical industry

The role
• Oversee process development for fermentation, purification and analytical characterization of novel biologics as a therapeutic/ vaccine candidate for use in developed markets
• Build DOE basis QBD.
• Build BOM/ COGS and process related documents
• Build project management templates and execute them efficiently with the team
• Working knowledge of ICH guidelines, and ability to develop processes wrt USFDA, EMEA and DCGI guidelines.
• Devise new processes, or refine existing ones, to optimise the manufacturing process in compliance to GMP for therapeutic or vaccine candidates (recombinant protein molecules) The production processes shall be Bacterial/ yeast-based fermentation processes.
• Scale up the production process via trials, making changes to raw materials or components, and process parameters to ensure quality is maintained during large-scale production.
• Preparation of SOPs, STPs in compliance to the process. Active trouble shooting to minimize the various risks prior to execution and during execution.
• Leads the technical transfer from R&D and to manufacturing.
• Generate data to substantiate claims regarding the safety and efficiency of new products.
• Plans, conducts, and directs scientific work on extremely complex projects necessitating the origination and application of new and unique approaches.
• Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis and operating procedures
• Reviews, technical documents for accuracy, thoroughness, and regulatory compliance.
• Analyze data, process results, summarize findings, and identify challenges to future commercial processes.
• Implementing steps to improve the efficiency of manufacturing in a cost-effective way.
• Presentation of data to stakeholders, both internal and external.
• Timely delivery of the deliverables.

Required Skills
• Person with high self-motivation, go-getter, enthusiastic with high level of integrity.
• Leadership skills, with steadfast resolve and personal integrity.
• Ability to work and liaise with cross-functional teams.
• Ability to handle global clientele/ customers/ auditors.
• Knowledge of GMP Setup.

Best Fit Profile
• Pilot scale manufacturing of Recombinant proteins; with main expertise in one of the streams: Analytics, USP, DSP and working knowledge of other two.
• Experience in Bacterial/ yeast host platform
• Experience in taking processes from RnD/ shake flask and developing pilot scale bioreactor processes/ product profile.
• Preferred Experience in a multi-disciplinary & multi-product environment with hands-on experience in devising & implementing pilot scale manufacturing processes.
• Advanced project management skills for execution and planning of multiple concurrent projects of moderate to high complexity.
• Identifies and independently drives department level improvements.
• Ability or experience in Tech transfer of processes, both from RnD into PDL and from PDL to Mfg/ client site.

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