10 Sep
|
Michael Page
|
Mumbai
10 Sep
Michael Page
Mumbai
About Our Client
This is a pharmaceutical organisation based in Mumbai.
Job Description
- Lead end-to-end technical oversight of the biosimilars portfolio across development, manufacturing, and commercialization activities.
- Serve as the primary technical SME, supporting manufacturing, packaging, quality, regulatory, and supply chain functions.
- Drive successful technology transfers, product launches, lifecycle management, and integration of acquired products.
- Manage relationships with CDMOs and external manufacturing partners to ensure uninterrupted product supply.
- Lead investigations and resolution of manufacturing, quality, compliance, and supply-related challenges.
- Ensure GMP compliance, technical governance, risk management, and continuous process improvement across products.
- Collaborate with global cross-functional teams to support regulatory submissions, product changes, and market expansion initiatives.
- Provide leadership to the technical services team, including performance management, capability building, and execution of strategic objectives.
The Successful Applicant
We're looking for someone who has:
- A robust background in technical operations, manufacturing and formulation in the pharmaceutical industry.
- Minimum 15 years of overall experience with at least 10 years hands on experience in biologics or biosimilar technical role (Drug substance / Drug product/ Formulation and fill finish - development / Tech transfer / Production / LCM) within the pharmaceutical or biotechnology industry preferably for regulated markets.
- Excellent technical knowledge base of biosimilar or biologic sterile pharmaceutical products from development of DS/ DP to commercial scale CMC aspects.
- Good understanding of biosimilar batch planning, manufacturing, packaging, testing and release arrangement with knowledge of product distribution and supply especially working with CDMOs.
- Excellent collaboration and communication abilities.
What's on Offer
- A pe
📌 Associate Director (Mumbai)
🏢 Michael Page
📍 Mumbai