Job Posting Details


Summary

POSITION: Senior Director, CMC Technical Operations

LOCATION: New York, NY (Midtown)

STATUS: Regular, Full-Time

REPORTS TO: TBD

SUMMARY:

The Senior Director, Technical Operations is responsible for leading and directing the manufacturing strategy for the company. He/she carries full budgetary responsibility for all process development and manufacturing operations and supply chain. This individual also provides technical briefings to the company’s CEO and executive team and, if/when needed, board members, investors and development partners, including all chemistry, manufacturing, and controls (CMC) for clinical stage products in preparation for commercialization of the company’s assets. The individual will be accountable for setting CMC strategy, the management of CMOs, and representing all aspects of CMC on cross-functional project teams to ensure that products are manufactured in compliance with all applicable regulations.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Provide functional and executive leadership of manufacturing strategy.
  • Develop effective and efficient working relationships with both internal and external partners.
  • Work closely with regulatory affairs to develop and implement CMC related Regulatory strategy, author and review CMC sections of regulatory submissions.
  • Ensure strategies in place to deliver for immediate and longer-term drug substance and drug product needs to meet clinical and preparedness for commercial needs.
  • Work closely with external manufacturing partners to ensure reliable, compliant execution against production schedules to meet company and program goals.
  • Work with external CMO’s, production, analytical, logistical, QA and technical leads to coordinate track and manage the review and approval of developmental, non GMP and cGMP batch records, analytical data and specifications, and other technical documents.
  • Develop, monitor, and report performance indicators to highlight progress, risks, and mitigation strategies.
  • Develops and manage approaches to forecasting to ensure product supply on time and in location, while minimizing waste.
  • Oversee the implementation and ongoing support of compliant cGMP manufacturing processes at raw material, drug substance, and drug product manufacturing sites.
  • Ensure performance of manufacturing sites in process validation and inspection readiness activities.
  • Drive continued improvement and operational excellence at CMOs to maintain a high level of compliance and efficiency to world-class manufacturing standards.
  • Lead Life Cycle Management of specialty raw material and commercial manufacturing processes to meet the needs of program and CMC team requirements.
  • Ensure CMO and internal compliance with cGMP and all related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports and records; perform technical data audits of CMC documentation intended for submission to regulatory health authorities.
  • Communicate operational status regularly to senior management and program teams.

EDUCATION AND/OR EXPERIENCE:

  • B.S. degree or equivalent experience in engineering, biopharma or pharmaceutical manufacturing. An M.S, or MBA degree is preferred.
  • 15+ years of relevant experience in manufacturing processes in pharmaceutical, biotechnology or a related industry focused on drug development.
  • Prior experience leading peptide CMC activities within a biotechnology company from the lead optimization phase through to commercialization – cancer vaccine/immunotherapy manufacturing highly desirable.
  • Experience working with contract manufacturing as well as working with collaboration partners.
  • Strong, clear experience in strategic management, planning and execution.
  • Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment.
  • Ability to work collaboratively, lead cross-functional teams/contractors to drive results and meet company objectives.
  • Ability to function independently and exercise good judgment.
  • Good analytical and problem-solving skills.
  • Excellent oral and written communication skills—both inside and outside the company.
  • Some travel required.

Qualified candidates are encouraged to submit their resume to careers@sellaslife.com.





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