Associate General Manager Manufacturing

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking an experienced professional to lead Upstream and Downstream processes for mammalian cell culture at our Ahmedabad location. The ideal candidate will oversee SOPs, QMS, and equipment qualification during early manufacturing stages and drive batch production as a Suite Lead.

The role requires extensive exposure to cell culture techniques, protein purification, and chromatography systems, with responsibility for change controls and vendor follow-ups.

Qualifications

• Life science graduates with postgraduate degree (M.Sc./B.E./B.Tech/M.Tech in Biotechnology/Microbiology).

Responsibilities

• Upstream process for Mammalian/Cell culture.
• Exposure to cell culture techniques (Single use Bioreactors, shake flasks, perfusion).
• Handle lab equipment (microscope, cell counter, osmometer, biochemical analyzer).
• Prepare SOPs, QMS, equipment qualification and validation in initial stage.
• Batch manufacturing responsibilities as Suite Lead.
• Downstream process for Mammalian/Cell culture.
• Protein purification techniques like chromatography, TFF, virus filtration.
• Operate chromatography systems (Cytiva/Sartorius).
• Column packing/unpacking and column qualification.
• New equipment introduction and suite qualification.
• Prepare QRM, change control, SOPs, vendor/CFT follow up for equipment qualification.
• Suite Lead role in downstream functions.

Education

Life science Graduate / Postgraduate

Tools

Bioreactors

Shake flasks

Perfusion technology

Microscope

Biochemical analyzer

Job description

Job Description:

Job Description

Following are the Details of the Job.

• Education: Life science Graduate / Postgraduate ( M.Sc./B.E./B.Tech/M.Tech (Biotechnology/Microbiology)


• Total Years of Experience: 18 - 20 Years


• Job Location: Ahmedabad

Departments Are As Follows

Upstream

• Responsible for Upstream Process for Mammalian/Cell culture.


• Should have exposure on various Cell Culture techniques such as Single use Bioreactors, shake flasks and perfusion technology.


• Lab equipment handling such microscope, cell counter, osmometer and biochemical analyzer.


• SOP preparation ,QMS, Qualification and validation of equipment in the initial stage and then responsible for Batch manufacturing.


• Position is required to be working as Suite Lead

Downstream

• Responsible for Downstream Process for Mammalian/Cell culture.


• Should have exposure to Protein purification Techniques like chromatography, TFF and virus filtration.


• Handling of Chromatography systems (Cytiva/Sartorius).


• Performed Column Packing/Unpacking & Column Qualification.


• New Equipment introduction & Suite qualification.


• Preparation of QRM, change control, SOP preparation, Vendor and CFT follow up for Introduction and qualification of downstream equipment’s.


• Position is required to be working as Suite Lead

Qualifications

Education

Life science Graduate / Postgraduate ( M.Sc./B.E./B.Tech/M.Tech (Biotechnology/Microbiology)