Vice President of Pharmaceutical Sciences

Natick, MA

Vice President of Pharmaceutical Sciences 1131069

Job Scope & Purpose:

Our client, a well-funded greater Boston based biotech, is developing small molecule therapeutics with a special focus on cancer metabolism and immuno-oncology, autoimmunity, and inflammation therapeutic areas. They are currently seeking a highly motivated and experienced leader to oversee chemical process development, manufacture and supply of all small molecule drug substances from the research stage through clinical development.

Primary Job Responsibilities:

  • Apply GMP manufacturing strategies of drug substances for development programs and commercial products
  • Manage the process chemistry for rapid and innovative development and scale up of target compounds in R&D pipeline.
  • Identify, select and manage CMOs for process optimization, cGMP manufacture and supply of API and DP in support of ongoing non-clinical and clinical programs
  • Deliver robust, scalable and cost-effective manufacturing routes for API manufacturing
  • Implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
  • Responsible for technology transfer, chemical outsourcing, and external manufacturing to deliver a robust supply chain for all drug substances incorporating quality, safety, compliance, cost effectiveness, sustainability and reliability to meet global demands
  • Design and implement drug substance regulatory strategy to ensure product quality, facilitate regulatory approvals globally and achieve operationally flexible supply chain
  • Writing and reviewing documents for INDs / regulatory section submissions
  • Design and develop formulations that meet target product profile for the clinic
  • Advocate a quality culture, maintaining safety and achieving high performance
  • Operational focus, fiscal accountability and long-term strategy in sync with R&D pipeline, commercial portfolio and company strategy.

Primary Job Requirements:

  • Ph.D. with 15+ in organic chemistry, process engineering and plant operations
  • Proven track record of establishing and delivering a robust supply chain for diverse drug substance portfolios to meet global product demand
  • Experience with small molecule drug substance manufacturing networks
  • Well versed in drug substance CMC strategy
  • Well versed in FDA and ICH guidelines relating to registration, quality and compliance concerning small molecule drug substance.
  • Strong business acumen including business contracting expertise
  • Experience with CMC requirements for drug development of new molecular entities
  • Proven ability to lead high performing teams

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.

 

jditlaia@stratacuity.com

 

Code: TechOps

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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.