AHMEDABAD · FULLTIME
Associate General Manager, Formulation & Development
Amneal Pharmaceuticals
Ahmedabad · onsite · Posted 23d ago
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Not disclosed15–17 yrsfulltimeAhmedabad
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Section · 01
About this role
Job Description
Biosimilar formulation development leader with 15 years of industrial experience and demonstrated end‑to‑end profile ownership for monoclonal antibody and insulin biosimilars.
Proven expertise in comparability‑driven, QbD‑based formulation strategy, encompassing formulation design and process development, technology transfer, and global regulatory submissions (BLA, MAA, NDS) across globe (US, EU, and Canada).
Broad technical foundation including drug–device combination products (vial, pre‑filled syringe and cartridge-embedded pen presentations), along with early‑career experience in GLP‑1 analogues, liposomal drug delivery systems, lyophilized injectables, and ready‑to‑use/ready‑to‑dilute formulations.
Recognized for cross‑functional scientific leadership and mentorship, lifecycle management decisions, and advancing patient‑centric, commercially ready biosimilar products aligned with global regulatory expectations.
Qualifications
Education: B.Sc., M.Sc., B.Pharm., IIP (Indian Institute of Packaging), M. Pharm., B.E./B. Tech (Biomedical, Mechanical, Pharmaceutical, or a related discipline), or equivalent life-sciences/engineering degree
Biosimilar formulation development leader with 15 years of industrial experience and demonstrated end‑to‑end profile ownership for monoclonal antibody and insulin biosimilars.
Proven expertise in comparability‑driven, QbD‑based formulation strategy, encompassing formulation design and process development, technology transfer, and global regulatory submissions (BLA, MAA, NDS) across globe (US, EU, and Canada).
Broad technical foundation including drug–device combination products (vial, pre‑filled syringe and cartridge-embedded pen presentations), along with early‑career experience in GLP‑1 analogues, liposomal drug delivery systems, lyophilized injectables, and ready‑to‑use/ready‑to‑dilute formulations.
Recognized for cross‑functional scientific leadership and mentorship, lifecycle management decisions, and advancing patient‑centric, commercially ready biosimilar products aligned with global regulatory expectations.
Qualifications
Education: B.Sc., M.Sc., B.Pharm., IIP (Indian Institute of Packaging), M. Pharm., B.E./B. Tech (Biomedical, Mechanical, Pharmaceutical, or a related discipline), or equivalent life-sciences/engineering degree
Sourced from foundit
Section · 02
Skills
Lyophilized Injectablescartridge-embedded pen presentationsinsulin biosimilarsliposomal drug delivery systemstechnology transferprocess developmentFormulation Developmentformulation designGlobal Regulatory Submissions
Section · Company
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
Employees rate it well for
Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65
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