Executive / Sr. Executive - Upstream Process Development

MSN Laboratories; Hyderabad; On-site; INR 900,000 - 2,000,000; Full time

Job summary

A leading pharmaceutical manufacturer in Hyderabad is looking for an Executive/Sr. Executive in Upstream Process Development. The ideal candidate will possess 2-7 years of experience in cell culture and fermentation, along with expertise in regulatory compliance and cGMP operations. Responsibilities include upstream process development from early-stage to commercial manufacturing, optimization of processes, and supporting regulatory inspections. This full-time role offers a pivotal opportunity to drive innovation in biologics production.

Qualifications

• 2-7 years of hands-on experience in upstream process development and manufacturing.
• Expertise in regulatory compliance and cGMP operations.
• Experience in troubleshooting and process improvement.

Responsibilities

• Develop upstream processes for mammalian and microbial systems.
• Oversee optimization and scale-up of upstream processes.
• Provide support for regulatory filings and audits.
• Innovate and implement new upstream technologies.
• Collaborate with downstream, analytics, QA, and regulatory.
• Support BLA filings, regulatory inspections, and audits.
• Drive new upstream technologies like perfusion, single-use systems, PAT.

Skills

Upstream process development

Cell culture

Fermentation

Regulatory compliance

cGMP operations

Process improvement

Scale-up

Process troubleshooting

Education

B.Tech / M.Tech / M.Sc. in Biotechnology or related field

Job description

Executive / Sr. Executive - Upstream Process Development

We are seeking a Upstream Process Development and Manufacturing professional with 2-7 years of hands‑on experience in cell culture, fermentation, scale‑up, and technology transfer for biologics production. The ideal candidate will have deep expertise in regulatory compliance and cGMP operations.

Key Responsibilities

• Upstream process development for mammalian and/or microbial systems from early‑stage development through commercial manufacturing.
• Oversee design, optimization, and scale‑up of upstream processes including cell line development, media/feed optimization, and bioreactor operations (shake flask to 2000 L+ scale).
• Provide troubleshooting, process improvement, and deviation management in commercial and clinical manufacturing.
• Direct technology transfer from process development to manufacturing or external CMOs.
• Collaborate with cross‑functional teams including downstream processing, analytical development, quality, regulatory affairs, and supply chain.
• Support BLA filings, regulatory inspections, and audits.
• Drive innovation and implement new upstream technologies (e.g., perfusion, single‑use systems, PAT tools).

Qualifications

• B.Tech / M.Tech / M.Sc. in Biotechnology or related field.

Position Details

• Seniority level: Executive
• Employment type: Full‑time
• Job function: Distribution
• Industry: Pharmaceutical Manufacturing
• Location: Hyderabad, Telangana, India