FUNCTIONAL LEAD- CELL LINE DEVELOPMENT

ORGANISATIONAL OVERVIEW

We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities.

Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products safely, effectively, and quickly.

Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.

JOB DETAILS

The candidate should lead the Cell Line Development Function within the Process Sciences group. The role entails utilization of the prospective candidate’s vast technical experience to lead a team that will be focused on cell line development for monoclonal antibodies using CHO or murine myeloma cell lines as expressions systems. An added advantage would be experience in generation of commercial cell lines for protein bio-therapeutics using bacterial and yeast expression systems.

KEY DELIVERABLES

• Provide technical leadership to clone development and cell line engineering.
• Have significant understanding in development of GMP cell banks for process development.
• Accountable for delivering robust clones for process development.

ALLIED RESPONSIBILITIES

• Must closely work with the cell culture team in transferring clones for process development.
• Must interact with vendors who license mammalian cell line technologies for mAb product development.
• Should be focused on assessing new technologies for development of higher productivity cell lines.
• Should work on newer technologies for single cell isolation of lead clones.
• Must learn on the job on the latest regulatory requirements for cell line characterization and defend the cell line development conducted with respect to single cell cloning etc.
• Responsible for authoring and reviewing technical reports, cell line development and cell banking protocols, and portions of regulatory submissions to support IND enabling data to initiate early development clinical trials.
• Identify and communicate best practices within the CDMO function.
• Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development

EXPERIENCE

EDUCATIONAL QUALIFICATION

• PhD in Biochemistry/Microbiology with 6 to 8 years or MSc in Biochemistry/Genetics/Microbiology with 8 to 10 years of work experience developing mammalian cell lines in biopharma/biotech or relevant contract research labs.
• Preference will be given for personnel having prior experience in leading a team in biopharma organizations that was focused on mammalian cell line engineering and development.

COMPETENCIES