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Manager/Sr. Manager, CMC Downstream Development and Manufacturing

Apex Systems

This is a Full-time position in Cambridge, MA posted June 11, 2021.

Senior Manager, CMC Downstream Development and Manufacturing 1142721

Job Scope & Purpose:

Our client is seeking a motivated individual with biological downstream process development experience to be part of a growing oncology company. S/he will join the Biological CMC Development and Manufacturing team as a Downstream Senior Manager.  The role is within a highly collaborative team environment. S/he will assist in developing and implementing operational plans to meet project timelines and the company’s business objectives.

Primary Job Responsibilities:

  • Assist in managing external drug substance and drug product development and external manufacturing sites
  • Collaborate with various internal and external functions including process development, analytical, quality, regulatory, and clinical
  • Assist in the development of robust purification processes utilizing multiple chromatography modes, filtration, and clarification technologies at CDMO site
  • In collaboration with CDMO design, optimize, and characterize downstream manufacturing
  • Ensure well-organized, clear and complete documentation of all activities across all areas of responsibility process based upon quality by design (QbD) principles
  • Assist in liquid drug product formulation development, technical transfer and fill at CDMO site
  • Assist with the technical transfer, scale-up and manufacturing of biological drug substance and drug product to support late-stage clinical studies
  • Interface with upstream, analytical, formulation, regulatory, QA/QC groups to ensure alignment with overall program objectives
  • Participate in designing phase appropriate viral clearance studies to enable regulatory submissions
  • Prepare supporting documents for CMC sections of regulatory submissions
  • Establish and maintain an understanding of current trends in purification technologies
  • Set clearly defined goals/objectives with contract organizations to ensure delivery of high- quality results while maintaining timeline and budget.

Primary Job Requirements:

  • BS or MS in chemical engineering, biochemistry, or closely related field
  • 6 – 10  years of relevant experience within a process development and/or technical transfer environment
  • Must have hands on experience with chromatography and membrane biological process development and scale up
  • Experience with external contract partners is desired but not required.
  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.

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.
PROVEN SCIENTIFIC PLACEMENT™

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.

krees@stratacuity.com

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 844-463-6178