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Scientist, Cell and Gene Therapy Analytical
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Job Description
This Scientist position will be part of Analytical Science and Technology (ASAT) team within Commercial Manufacturing & Supply Chain (CMSC) department. S/He will provide expertise in certain analytical area supports to the commercial manufacturing and product release for the Cell and Gene therapy (CGT) portfolio.
Key Responsibilities:
· Work independently or in collaboration with internal and/or external partners in analytical lifecycle activities including method development, validation, and method transfer
· Be a Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and OOS investigation occurred during release and/or stability testing
· Provide SME assessment for deviation, CAPA and change control
· Participate in internal and external meeting
· Author and/or review technical documents, including method SOP, study protocol and technical report
Knowledge and Skills:
· Hands-on experience and In-depth knowledge of potency or microbiology assays
· Experience in Gene and Cell therapy is desirable
· Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept.
· Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
· Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
· Partners effectively with internal and external functions
· Experience of using JMP or similar statistical tools is plus
· Good technical writing skills
Education and Experience:
· B.S or above in Biology and related field.
· Minimum 4 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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