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.