JOB DESCRIPTION:

Purpose of Role

Injectables, Biosimilars expertise required, In addition, expertise on Oral dosage forms (Technology transfer & Project Management).

• 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.
• End to end project management of technology transfers and Alternate source qualifications in the region METAP-CIS
• 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
   

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.
• Lead project management activities across Egypt to ensure product reliability, support portfolio growth, cost improvement (ASQs, Tech Transfers, Compliance and Continuous Improvement)
• The responsibilities of this role include the technical support for internal and external manufacturing within the region as below:
• Support business decision-makers in terms of resource allocation, risk management, collaboration, and prioritization.
• Operational technical support to ensure product reliability, support portfolio growth, cost improvement by optimize.
• 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:

Manufacturing

     

DIVISION:

EPD Established Pharma

        

LOCATION:

India > Salcette : Goa Factory

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 25 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)