Executive Manufacturing

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 350,000 - 700,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad is seeking an Upstream Production Specialist for its Biosimilar manufacturing facility. The role focuses on upstream mammalian cell culture and equipment handling.

The candidate will work with SOPs, QMS, and qualification/validation of equipment, and participate in batch manufacturing, with exposure to regulatory audits and documentation practices.

Qualifications

• Experience in Biosimilars Upstream production (Mammalian culture) preferred.
• Exposure to Perfusion technology is a must.
• Exposure to Regulatory Audit is required.
• Experience with QMS Documentation.

Responsibilities

• Upstream Production for Mammalian cell culture.
• Handle cell culture techniques such as single-use bioreactors, shake flasks and perfusion.
• Operate lab equipment: microscope, cell counter, osmometer, biochemical analyzer.
• Prepare SOPs, participate in QMS, qualification and validation of equipment; handle batch manufacturing.

Skills

Upstream production

Mammalian cell culture

Perfusion technology

QMS documentation

Regulatory audit exposure

Education

Life science Graduate / Postgraduate

Tools

Microscope

Cell counter

Osmometer

Biochemical analyzer

Job description

Job Description:

We are looking for Upstream Production Specialist for our Biosimilar manufacturing facility based out of Ahmedabad. Following are the Roles and Responsibilities.

• Education: Life science Graduate / Postgraduate
• Total Years of Experience: 1 – 4 Years
• Job Location: Ahmedabad

Roles & Responsibilities

Upstream

• Responsible for Upstream Production 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.

Candidate Details

• The candidate should have worked in Biosimilars Upstream production (Mammalian Culture) for at least 5 Years and exposure to Perfusion technology is must.
• Exposure to Regulatory Audit is Must.
• Should be aware of QMS Documentation.

The candidate should have good communication skills

Qualifications

Education: Life science Graduate / Postgraduate