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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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com