Senior Scientist I (Biosimilar, Biologics expertise)

JOB DESCRIPTION:

Purpose of Role

Injectables, Biosimilars expertise required, In addition, expertise on Oral dosage forms

• Providing technical support to Abbott manufacturing facilities and Third-Party Manufacturers (TPM' s) in the region. Collaboration with Manufacturing, Supply Chain, Commercial, Quality Assurance and Regulatory Affairs is critical to the success of this role.
• Troubleshoot the commercial manufacturing issues to avoid the supply chain disruption.
• Support the product localization considering cost estimates// regulatory requirement,, business plans, timelines and contingency plans for responsible projects in areas of  CIP/ Alternate Vendor Development/ Gross Margin Improvement/ Supply
• Review of dossier/ tech pack that supports the department in providing rapid and accurate evaluation of new business opportunities like in licensing/ co-marketing.

Minimum Education Qualification for the role

Post Graduation in Pharmacy (Pharmaceutical Science)

Minimum Experience/ background for the role

• 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 work closely to meet the role responsibility.
• Can exhibit smart working capabilities, be Agile, to meet the expectation.

Core Responsibilities

• Expertise in Injectables, Biosimilars as primary requirement and experience in handling Oral dosage forms as additional requirement.
• Providing technical support to Abbott manufacturing facilities and Third-Party Manufacturers (TPM' s) in the region. Collaboration with Manufacturing, Supply Chain, Commercial, Quality Assurance and Regulatory Affairs is critical to the success of this role.
• The responsibilities of this role include the technical support for internal and external manufacturing within the region as below:
• Operational technical support to ensure product reliability, support portfolio growth, cost improvement by optimize.
• Supporting local technical team at each of the manufacturing sites and for 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 finalising a product deal.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:ManufacturingDIVISION:EPD Established PharmaLOCATION:India > Salcette : Goa FactoryADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 25 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)