Sun Pharma Job – Biotech / Biology & Biochem Vacancy
Sun Pharma Job – Biotech / Biology & Biochem Vacancy. Biotechnology, Biochemistry and Biology Sun Pharma Job Opening. Process Engineer Jobs for Biotech/ Biochem and Biology. Interested and eligible applicants can check out all of the details on the same below:
Name of the Post: Manager Process Engineer – External Manufacturing and Supply – Biologics
Location: Mumbai, Maharashtra, India
Seniority Level: Mid-Senior level
Industry: Pharmaceuticals
Employment Type: Full-time
Job Functions: Other
Primary Objective:
The Process Engineer will support the manufacture of drug substance (API) and drug Product (fill-finish and secondary packaging) of biologics. The activities range from tech transfer, technological process studies, process validation activities, data analysis to handing change controls, deviations and troubleshooting. Writing and also reviewing of DS/DP validation-related documents and key CMC sections of regulatory dossiers (different countries) are additionally required for this position.
Major Duties/Responsibilities:
- Support the operational activities at DS & DP CMO’s, as well as testing of DS/DP throughout the value chain.
- Performs Continuous Process Improvement and Process Optimization to reduce Cost of Goods.
- Subject Matter Expert (SME) on multidisciplinary CMC teams to guarantee scientifically driven decisions made.
- Review and approve master batch records, change controls, as well as deviations, CAPA to guarantee GMP compliance and operational success.
- Preparation and review of documents such as technological reports, validation documents, deviation reports and also regulatory modules.
- Help in the development of specifications for raw materials, consumables, process intermediates and drug substance.
- In collaboration with Quality, Regulatory Affairs, Project management and analytical groups support the CMO operations to achieve on-time manufacturing.
- The applicant will communicate across the organization to ensure key stakeholders are aware of project status, potential risks as well as their required action plans.
- Various other duties as assigned.
Education: BS, MS or PhD degree in (bio) chemical engineering, biotechnology, biochemistry or biology.
Location: Mumbai.
Professional Experience:
- Doctorate degree and 1-3 years of related experience – or- Master’s degree and also 2-5 years of associated experience – or- Bachelor’s degree and also 4-7 years of direct experience in Biologics GMP manufacturing.
- Experience in cGMP is a must.
- Experience in data handling as well as analysis. Knowledge of statistical tools.
- Knowledge of analytical testing methods, as well as the impact on product quality specifications, is advantageous.
- Capability to diagnose complex issues; develop as well as implement solutions by collaborating with various other teams.
- Capability to influence internal as well as external stakeholders through scientific justifications.
Skills & Capabilities:
- Excellent interpersonal and also communication, presentation skills.
- Excellent organizational and also project management skills, work well under pressure.
- Capability to thrive in a small group setting with minimal administrative support.
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