Functional Lead- Cell Line Development

8-10 years

Not Disclosed

Ahmedabad

10 Dec. 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Functional Lead - Cell Line Development
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
Posted Date: Nov 25, 2024

Organizational Overview:
Lambda Therapeutic Research Ltd. is a globally recognized Clinical Research Organization (CRO), headquartered in Ahmedabad, India, with a presence in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA), and Fargo (USA). With over 1500 employees across these locations, Lambda offers a comprehensive range of clinical trial solutions to the biopharmaceutical and generic industries. For over 20 years, we have delivered high-quality services using advanced technologies, therapeutic expertise, and a commitment to excellence. Our team is dedicated to helping clients develop their products safely, effectively, and efficiently.

Job Description:
Lambda Therapeutic Research is seeking a Functional Lead - Cell Line Development within the Process Sciences group. The selected candidate will leverage their extensive technical experience to lead a team focused on developing cell lines for monoclonal antibodies (mAbs) using CHO or murine myeloma cell lines as expression systems. Experience in generating commercial cell lines for protein biotherapeutics using bacterial and yeast expression systems would be an added advantage.

Key Deliverables:

Lead technical efforts in clone development and cell line engineering.
Develop GMP cell banks for process development.
Ensure the delivery of robust clones for use in process development.

Allied Responsibilities:

Collaborate closely with the cell culture team to transfer clones for process development.
Work with vendors licensing mammalian cell line technologies for mAb product development.
Assess and implement new technologies to improve cell line productivity.
Stay updated on regulatory requirements for cell line characterization and defend processes such as single-cell cloning.
Author and review technical reports, cell line development and banking protocols, and portions of regulatory submissions supporting IND-enabling data for early-stage clinical trials.
Share best practices within the CDMO function.
Lead and mentor a technical team, fostering professional growth.

Experience and Educational Qualification:

PhD in Biochemistry/Microbiology with 6-8 years of relevant experience, OR
MSc in Biochemistry/Genetics/Microbiology with 8-10 years of experience in developing mammalian cell lines in biopharma/biotech or contract research labs.
Preference for candidates with prior leadership experience in biopharma organizations focused on mammalian cell line engineering and development.

Key Competencies:

Accountability and leadership in guiding technical teams
Excellent communication, organizational, and planning skills
Initiative, flexibility, and strong work ethic
Ability to motivate and mentor others
Strong interpersonal skills and a passion for leadership
Technical expertise in cell line development

Why Lambda?
At Lambda, we believe in the power of our people. We are committed to delivering the best results, which is why we invest in our employees’ growth and well-being. If you are looking for a place to apply your expertise and make a meaningful impact in a global organization, Lambda is the place for you.

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Functional Lead- Cell Line Development

Job Description

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