Lead Upstream Process Development for Advanced Biologics
Drive Process Innovation & Scale-Up in a Global CRO/CDMO Environment
Lambda Therapeutic Research is a premier global Clinical Research Organization (CRO) and Contract Development partner, dedicated to accelerating the development of next-generation biologics. With our headquarters in Ahmedabad and a strategic international network, we provide end-to-end services from cell line to clinic. We are seeking a seasoned Upstream Process Development Scientist to lead the design, optimization, and scale-up of mammalian cell culture processes for monoclonal antibodies (mAbs) and other complex proteins.
Key Responsibilities
Advanced Bioreactor Operations & Process Development
- Lead upstream process development activities using bioreactors from bench-scale (e.g., AMBR systems) to pilot-scale (50L, 200L) in GMP suites.
- Demonstrate high technical proficiency in sterile cell culture operations, bioreactor setup (STR, wave), autoclaving, and instrument calibration.
- Design and execute process optimization studies using Quality by Design (QbD) principles to achieve high yield and targeted Critical Quality Attributes (CQAs).
- Scale up optimized processes and lead the execution of consistency batches at 50L and 200L scale.
High-Throughput Screening & Data Analysis
- Utilize advanced microbioreactor systems (AMBR 15 & AMBR 250) for high-throughput process screening and optimization.
- Skillfully analyze process data using instruments such as Vi-CELL analyzer, Blood Gas Analyzers (BGA), and CEDEX.
- Collate, analyze, and present development data using Design of Experiment (DOE) software (e.g., Minitab, JMP) to drive scientific decisions.
Technical Documentation & Compliance Leadership
- Author and review high-quality technical documents, including protocols, process development reports, and Electronic Laboratory Notebook (ELN) entries.
- Support technology transfer activities, troubleshoot process deviations, and prepare documentation such as CAPA reports.
- Ensure rigorous lab compliance, maintain impeccable records, and uphold all relevant quality standards.
Project & Team Leadership
- Manage upstream process-related project timelines to ensure on-time completion of development milestones.
- Provide technical leadership and mentorship within the upstream team, potentially leading a small group of scientists.
Qualifications & Experience
Essential Requirements:
- MSc, MTech, or PhD in Biotechnology or a closely related field.
- 6 to 10 years of direct, hands-on experience in developing mAb upstream processes from mammalian cell lines within a biopharma, biotech, or relevant CRO/CDMO.
- Extensive practical experience with AMBR 15/250 systems and 50L/200L disposable bioreactors in a GMP environment.
- Proven expertise in process optimization, scale-up/scale-down, and process characterization using QbD principles.
- High proficiency in process analytical tools (Vi-CELL, BGA) and DOE software (Minitab, JMP).
- Excellent technical writing skills for protocols, reports, and regulatory documentation.
Preferred Attributes:
- Prior experience in a team lead or supervisory role within an upstream processing unit.
- Strong background in tech transfer, deviation management, and CAPA processes.
- A proven track record of successful process scale-up to manufacturing scales.
Why Build Your Career at Lambda?
- End-to-End Impact: Your work directly shapes processes for life-changing biologics, from development through to manufacturing support.
- Technical Excellence: Work with state-of-the-art equipment and advanced methodologies in a science-driven environment.
- Global Leadership: Assume a senior technical role with significant influence on project strategy and execution for international clients.
- Career Growth: Clear pathway to Principal Scientist or Group Lead positions within our expanding Biologics Development division.
- Collaborative Innovation: Integrate with cross-functional global teams in Cell Line Development, Downstream Processing, and Analytics.
Ready to scale your expertise and lead upstream innovation for global partners?
Apply now for the Senior Scientist/Lead Scientist position in Upstream Process Development.
- Lambda Therapeutic Research is an equal opportunity employer. We champion diversity and are dedicated to creating a workplace where scientific innovation is fueled by inclusive collaboration.
