Specialist/Sr. Specialist, CMC

Cambridge, MA

Specialist/Sr. Specialist, CMC 2032102
Location: Cambridge, MA (Hybrid)
Science: Antigen Therapies
Therapeutic Areas: Autoimmune Diseases
Job Overview: This role involves leading key CMC activities, collaborating across departments, and managing critical analytical and manufacturing processes in a cGMP environment as part of the Technical Operations team.
Primary Job Responsibilities:

  • Serve as the primary expert in core analytical methods, guiding their use in product release and stability under both cGMP and non-cGMP standards.
  • Lead the development, transfer, and validation of analytical methods for preclinical and early-phase clinical projects across internal and external sites.
  • Direct CMC team efforts by organizing meetings, establishing agendas, recording decisions, assigning tasks, and tracking progress to ensure timely achievement of project objectives.
  • Collaborate with Quality and external partners to manage stability studies and review data for regulatory reports, while overseeing CMC quality documentation and vendor relationships to support analytical and manufacturing excellence.
Primary Job Requirements:
  • BS, MS, or PhD in chemistry, biochemistry, or chemical engineering with at least 3 years in CMC analytical development in biotech/pharma.
  • Expert in large molecule analytics, including HPLC and MS, with a solid track record in analytical method development focused on SISPQ principles.
  • Experienced in cGMP pharmaceutical manufacturing and release, with skills in managing external manufacturing/testing partnerships.
  • Strong communication and self-motivation skills, adept at working in fast-paced environments, and proficient in Microsoft Office and project management software.

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

 

 

 

 

 

 

 

 

 

 

 

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@apexsystems.com or 844-463-6178.

Employee Type:
Contract

Location:
Cambridge, MA

Job Type:
Strata: TechOps.

Date Posted:
June 19, 2024

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