Senior Scientist- Biologics Expertise Job in Mumbai at Abbott

Abbott is hiring for the role of Senior Scientist I (Biosimilar, Biologics expertise)

Responsibilities of the Candidates:

• Providing technical support to Abbott manufacturing facilities and Third-Party Manufacturers (TPMs' s) in the region. Collaboration with Manufacturing, Supply Chain, Commercial, Quality Assurance, and Regulatory Affairs is critical to the success of this role.
• Operational technical support to ensure product reliability, support portfolio growth, and cost improvement by optimization.
• Supporting local technical teams at each of the manufacturing sites and for the continuous growth of the technical organizations & teams across the region.
• Lead Technology transfers, ASQ (API Supplier) qualifications, Localization Programs, Gross Margin Improvements, etc.
• Responding to technical issues resulting from manufacturing, compliance, or regulatory CMC deficiencies (Biowaiver, IVIVC & technical justification based the regulatory query).
• Lead technical Due diligence of products, Third party manufacturing sites before selection of manufacturing sites of finalizing a product deal.

Requirements:

• Sound knowledge of formulation development (Research & Development), manufacturing process (understanding of commercial equipment), Hands-on experience with Alternate source qualification for API, Excipients (functional & non-functional) and packaging materials of Injectable formulations, Biosimilars and Oral Dosage forms.
• Have the basic understanding and expertise of the formulation/product behavior to mitigate the process-related risk.
• Keeping up good contacts with CFT team members and working closely to meet the role responsibility.
• Can exhibit smart working capabilities, be Agile, to meet the expectation.
• Post Graduation in Pharmacy (Pharmaceutical Science)
• Expertise in Injectables and biosimilars as a primary requirement and experience in handling Oral dosage forms as additional requirement.