Senior Director, CMC in Waltham, MA at APEX Systems

Date Posted: 9/20/2019

Job Snapshot

Job Description

Job #:  1008828
Senior Director, CMC 1008828
Job Purpose and Scope:
Our well-funded oncology focused startup, located west of Cambridge, is seeking a critical hire to lead and grow its CMC department.  The ideal candidate will be focused on shaping the culture for this start-up, and will develop and implement CMC manufacturing and regulatory strategies for both DNA/RNA and small molecule drug substance and drug product.  If you are passionate about providing critical therapies, and want an opportunity to grow and lead a CMC function with established and dynamic thought leaders, then this is the opportunity for you.  Reach out to Kevin Rees or Todd Jamison to learn more!
Primary Job Responsibilities:
  • Oversee Contract Manufacturing Organizations (CMOs), including oversight of technical solutions that are best suited for each compound in development, as well as budgeting, timelines, quality and scope of all deliverables
  • Drive the submission of regulatory CMC documents to FDA and authorities in compliance with GMP and international requirements, including the authoring of  regulatory CMC documents for the submission of INDs
  • Ensure all development activities are in compliance with CMC regulatory requirements and regulations
  • Serve as the SME of all CMC activities in internal leadership meetings, as well as in meetings with business partners and regulatory agencies
  • Ensure compliance with all regulatory requirements, including annual and periodic reports
  • Collaborate with contract staff and vendors as needed to support manufacturing and regulatory activities
  • Support drug supply chain planning as needed
  • Maintain effective working relationships with internal team members and external partners
  • Exhibit making timely, data-driven decisions to ensure a high quality outcome
  • Provide guidance, coaching and mentoring to junior team members

Primary Job Requirements:
  • Advanced degree in Chemistry, Biochemistry or related pharmaceutical science field with a minimum of 10 years experience in CMC projects
  • Proven experience in drug product development with biologics, protein synthesis or small molecule, with additional experience in small molecules and/or drug substance strongly preferred
  • Experience overseeing CMOs, including project management and providing technical solutions, is required
  • Strong knowledge of eCTD elements and regulatory writing skills
  • Demonstrated understanding of research, technical development, GMP Manufacturing, Quality, Supply Chain, Regulatory, Clinical and Product Strategy functions and the interdependencies of those functions
  • Experience managing a team is required
  • Strong communication and written/verbal skills are required, and ability to speak Chinese would be a plus, but not required

 
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.
 
tjamison@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 844-463-6178-6178.