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Manager/Senior Manager, Cell Therapy Manufacturing

Company: Stratacuity: Proven Scientific Placement
Location: Waltham
Posted on: September 13, 2020

Job Description:

Manager/Senior Manager, Cell Therapy Manufacturing Waltham, MA

Manager/Senior Manager, Cell Therapy Manufacturing 1054029

Job Scope and Purpose:

Our rapidly growing Greater Boston area client is seeking a leader for its GMP Manufacturing Cell Therapy unit. The ideal candidate will drive delivery of manufacturing start-up activities and contribute to GMP manufacturing operations across a multi-product portfolio. This individual will lead a manufacturing team performing GMP manufacturing of allogenic and autologous cell therapies and provide additional leadership across both cell therapy and viral vector manufacturing. For more information on this exceptional opportunity, reach out to Todd Jamison or Kevin Rees today.

Primary Job Responsibilities:

Serve as a cell therapy subject matter expert for aseptic processing and GMP manufacturing within the organization

Provide hands-on expertise in ensuring timely and proper delivery to GMP cell therapy manufacturing needs across a number of products, including equipment selection, batch records, SOPs, report, risk assessments, and the ordering of materials

Develop as part of a cross-functional team (process development, engineering, quality) scalable GMP cell therapy manufacturing processes

Provide daily management oversight and lead a team in the manufacturing of allogenic and autologous cell therapy products

Identify and escalate key issues to leadership as needed, and work with a cross-functional team to develop risk mitigation plans and management of complex operational issues

Ensure proper "right first time" technology transfers with cross functional teams

As needed, act as a key client interface with partners at tactical and strategic meetings

Proactively resolve issues (deviations, CAPAs, Change Controls), review completed batch records, and identify proactively opportunities for process, safety, cost and quality improvements

Support the hiring, and initial and ongoing training of manufacturing staff

Primary Job Requirements:

BS in an applicable science or engineering discipline, with an advanced degree preferred, and a minimum of 8 years experience in GMP biotech manufacturing, and a minimum of 5 years cell therapy manufacturing exposure

Proven leadership experience and project management and ownership experience is required

Experience with manufacturing and process development for some of the following: CAR-T, TCR, NK, and cellular therapies

Preferred experience with MES and integrated automation

Experience with understanding of primary cell culture required

Experience with CliniMACS, LOVO, WAVE bioreactors required

Ability to work off-hours (nights, weekends, holidays) as needed to support business needs

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Code: TechOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

Apex Systems dba Stratacuity, is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Keywords: Stratacuity: Proven Scientific Placement, Waltham , Manager/Senior Manager, Cell Therapy Manufacturing, Other , Waltham, Massachusetts

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