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Director, Cell Culture Process Development
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At ProClincial, we are seeking a talented and experience individual to fill the role of Director of Cell Culture Process Development, based in Cranbury, NJ.
Responsibilities
- Strong interface with cell and molecular biology team with development approach and strategy.
- Serve as subject matter expert related to upstream process development.
- Build a high performing group focused on execution, data analysis.
- Mentor technical and junior staff to understand technical and regulatory requirements for process development.
- Support upstream process control strategy for monoclonal antibodies manufacturing processes.
- Oversee the execution of upstream process characterization studies.
- Support tech transfer to manufacturing through authoring and change management of process descriptions (TTPs).
- Plan and conduct experiments to define upstream manufacturing process parameters or optimized media formulations.
- Establish and qualify appropriate scale-down models to support process characterization.
- Evaluate opportunities for improving process robustness or reducing cost of goods.
- Lead development of 2nd generation processes for implementation post-approval.
- Author appropriate CTD sections for submission to regulatory agencies.
- Enable prosecution of mAb biosimilar pipeline as well as other projects that may be assigned.
- Represent the Company before EU and FDA regulatory authorities.
Skills And Qualifications
- MS or PhD in relevant degree and 10+ years of relevant experience.
- Experience in biotechnology drug development, with clear understanding of CMC requirements.
- Experience with development of stable, high producing mammalian cell lines that meet health authority guidelines.
- Experience in authoring a BLA/MAA which resulted in approval and marketed product support.
- Experience with process and media development for mammalian cell culture along with knowledge of filtration principles and capacity determination.
- Experience with mAbs or similar biologics manufactured utilizing single-use technology.
- Strong understanding of Quality by Design and Risk Management.
- Excellent written, verbal, and interpersonal communication skills, including English fluency.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Goldberg at (+1) 2674056995 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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