Junior Executive, Manufacturing

Amneal Pharmaceuticals LLC; Sanand; On-site; INR 400,000 - 700,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks an Upstream & Downstream Process Specialist for its Biosimilar manufacturing facility in Ahmedabad. Education: Life science graduate/postgraduate with MSc/B.E./B.Tech/M.Tech in biotech/microbiology. 0–2 years of experience.

Responsible for upstream and downstream operations, cell culture techniques, chromatography, TFF, virus filtration, and equipment qualification. You will handle SOPs, QMS, vendor coordination, and participate in batch manufacturing and

Qualifications

• Life science graduate/postgraduate with MSc/B.E./B.Tech/MTech in biotech/microbiology.
• 0–2 years of total experience in biosimilar manufacturing.
• Experience in upstream mammalian/cell culture processes and related lab techniques.
• Exposure to protein purification techniques including chromatography, TFF and virus filtration.
• Handling chromatography systems (Cytiva/Sartorius) and related equipment.
• Column packing/unpacking and column qualification.
• New equipment introduction and suite qualification.
• Preparation of QRM, change control, SOPs, and vendor/CFT follow-up for downstream equipment qualification.

Responsibilities

• Support upstream process development and manufacturing for mammalian/cell culture lines.
• Assist downstream processing including purification steps and related QC checks.
• Operate and maintain lab instrumentation (microscope, cell counter, osmometer, biochemical analyzer).
• Assist in SOP creation, QMS documentation, and equipment qualification activities.
• Contribute to batch manufacturing and equipment qualification tasks as needed.

Skills

Upstream process

Downstream process

Cell culture

SOP knowledge

QMS

Qualification & validation

Column chromatography

Virus filtration

Lab equipment handling

Education

Life science graduate / postgraduate

Tools

CytivaSartorius systems

Chromatography systems

Bioreactors

Single use bioreactors

Osmometer

Biochemical analyzer

Cell counter

Job description

We are looking for Upstream & Downstream Process Specialist for our Biosimilar manufacturing facility based out of Ahmedabad. 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: 0 - 2 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.

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

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

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