Process Development Lab Team Lead

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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