This site uses cookies. To find out more, see our Cookies Policy

Director/Senior Director, CMC in Boston, MA at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Boston, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/7/2018
  • Job ID:
    920009

Job Description


Director/Senior Director, CMC - 920009

Job Scope & Purpose:

Our Boston-area client is seeking a Director-level and experienced CMC professional to lead the development of chemical processes for scale-up and manufacturing of API for its multiple clinical assets for rare-disease focused programs. This individual will be responsible for all aspects of the manufacturing of drug substance - from strategy, selection and oversight of CMOs, data analysis, QC/auditing and oversight of study reports, as well as being a Process Chemistry and API internal SME for cross-functional development teams. If you are seeking to work in a fast-paced and nimble environment in a virtual setting, then reach out to Todd Jamison to learn more.

Primary Job Responsibilities:

  • Develop and implement comprehensive strategies to manufacture drug substance, and assume all aspects of drug substance process research, manufacturing, and analytical development
  • Lead CRO/CMO strategy including selection and contract negotiation, ongoing troubleshooting, data analysis and interpretation, QC/audit, and oversight of study report writing, and manage solid state and pre-formulation development, when needed
  • Identify and manage GMP drug substance and drug product manufacturing of solid oral dosing forms
  • Serve as SME in the areas of non-clinical CMC to both preclinical and development project teams
  • Author, review and approve applicable CMC portions of regulatory filings
  • When needed, engage in discovery chemistry activities to help transition optimized leads into preclinical development
  • Strong knowledge of GMP regulations as well as familiarity with regulatory requirements surrounding import and distributions.

Primary Job Requirements:

  • Ph.D. preferred in a relevant area of study, with a minimum of 10 years of relevant experience in pharmaceutical GMP development and process chemistry
  • Strong foundation in chemistry, materials science, pharmaceutical sciences or chemical engineering required
  • Drug product development experience is preferred
  • Ability to provide hands-on problem-solving skills and strong critical thinking
  • Proven experience as a direct manager of people or external teams, and as a leader for milestone and budget-driven projects
  • Strong background in modern synthetic organic chemistry and drug development processes required
  • The desire to work in a fast-paced, timeline-driven environment, and ability to manage outsourced projects with external vendor
  • Outstanding written and verbal communication skills, with the ability to convey CMC strategies and results to a varied audience

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 at info@stratacuity.com or 877-787-2821.

Code: TechOps

EEO Employer

Apex 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. 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.




920009