Functional Lead - Upstream Processing

Biocon Biologics; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Biocon Biologics Bengaluru seeks an experienced Functional Lead - Upstream Processing to lead development, scale-up and characterization of cell culture processes for monoclonal antibodies and fusion proteins, spanning development through transfer and commercialization.

You will design experiments, apply QbD, DOE and risk assessment, mentor a team of 5–15 scientists, and collaborate closely with Manufacturing, QA, Regulatory, and Program Management to ensure timely milestones and robust

Qualifications

• Strong experience in upstream process development for biologics.
• Hands-on with design of experiments (DOE) and QbD.
• Knowledge of regulatory expectations (FDA/EMA/ICH).

Responsibilities

• Lead upstream process development, scale-up and characterization.
• Design and execute experiments in shake flasks, Ambr systems, bioreactors.
• Collaborate with Manufacturing, QA, Regulatory, and PMO.
• Support tech transfer and milestone delivery across projects.
• Mentor a team of scientists (5-15) and foster learning.

Skills

Upstream process development

Process scale-up

Process characterization

Bioprocess development principles

Cell culture technologies

Biologics manufacturing

Statistical analysis

JMP

Minitab

Education

Master's degree in Biotechnology / Bioprocess Engineering

PhD in Biotechnology / Bioprocess Engineering

Post-Doctoral research experience

Tools

JMP

Minitab

Job description

Role : Functional Lead - Upstream Processing

Role in a Nutshell:

We are seeking an experienced Upstream Process Development professional to lead the development, scale-up, and characterization of cell culture processes for monoclonal antibodies (mAbs) and fusion proteins. The role offers the opportunity to work across multiple biologics programs, driving robust and scalable manufacturing processes from development through technology transfer and commercialization.

Why Join Us?

Be part of a high-impact biologics R&D organization focused on advancing innovative therapies through cutting-edge process development, scientific excellence, and collaborative innovation.

Key Responsibilities:

• Lead upstream process development, optimization, scale-up, and process characterization activities for biologics programs.
• Design and execute experiments in shake flasks, Ambr® systems, and laboratory-scale bioreactors, with scale-up support up to pilot scale (50L and beyond).
• Develop scalable, robust, and efficient cell culture processes to meet product quality, productivity, and commercialization targets.
• Apply Quality by Design (QbD), statistical tools, Design of Experiments (DOE), and risk assessment methodologies to support process development and technical decision-making.
• Collaborate closely with cross-functional teams including Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and Program Management.
• Support technology transfer activities and ensure timely delivery of development milestones across multiple projects.
• Contribute to regulatory submissions, audits, inspections, and preparation of technical dossiers.
• Analyze experimental data and provide scientific insights to drive process improvements and development strategies.
• Ensure compliance with Good Documentation Practices (GDP), data integrity requirements, and regulatory expectations.
• Prepare technical reports, development protocols, presentations, and SOPs/IOPs/EOPs.
• Lead and mentor a team of 5-15 scientists, providing both technical guidance and people management support.
• Foster a culture of scientific excellence, collaboration, and continuous learning through technical and non-technical training initiatives.

Required Expertise:

• Strong experience in upstream process development, process scale-up, and process characterization for monoclonal antibodies (mAbs) and fusion proteins.
• In-depth understanding of bioprocess development principles, cell culture technologies, and biologics manufacturing.
• Hands-on experience with statistical analysis and software tools such as JMP, Minitab, or equivalent.
• Strong knowledge of global regulatory expectations, including US FDA, EMA, ICH guidelines, QbD principles, and risk-based development approaches.
• Proven ability to manage multiple projects simultaneously while delivering high-quality scientific outcomes within timelines.
• Excellent communication, stakeholder management, and cross-functional collaboration skills.
• Awareness of emerging trends and advancements in biologics and bioprocessing technologies.

You would be a perfect fit if you have :

• Master's Degree (MTech, MSc) in Biotechnology, Chemical Engineering, Bioprocess Engineering, or a related discipline with 10-15 years of relevant industry experience OR
• PhD in Biotechnology, Chemical Engineering, Bioprocess Engineering, or a related discipline with 6-10 years of relevant industry experience OR
• Post-Doctoral research experience in a relevant field with significant industrial exposure.

Biocon is an Equal Opportunity Employer and is committed to fostering a diverse, inclusive, and respectful workplace. We encourage applications from qualified candidates of all backgrounds and experiences.