Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Associate Director, Drug Substance CMC

Boston, MA · Director · Contract

Sponsorship not specified$170k-$195kDetected 12 days ago
ProcurementGMPResearchCommunication

About the role

  • Description of Role Centessa is seeking an Associate Director, Small Molecule Drug Substance Process Chemistry.
  • Work Location The Associate Director, Drug Substance CMC role is based in the US, with occasional travel <span class="NormalTextRun SCXW107147065 BCX0" data-ccp

Responsibilities

  • Collaborate with CRO/CDMOs and expert consultants to address process chemistry challenges and develop manufacturing processes that are scalable, safe and cost-effective.
  • Author and review technical reports, tech transfer packages, and GMP production records as well as CMC sections regulatory related documentation (ie. INDs) submission, and any documents related to intellectual property.
  • Build and maintain strong relationships with internal and external stakeholders
  • proactively seek buy-in and provide on-going support to address business needs.
  • Build and maintain strong relationships with internal and external stakeholders; proactively seek buy-in and provide on-going support to address business needs.

Requirements

  • PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant biotech/pharmaceutical industry experience
  • 10+ years of experience in biotech/pharmaceutical industry in small molecules, working in early to late development (pre-clinical to phase 3)
  • Extensive experience in process chemistry development, scale-up, tech transfer and process characterizations, as well as deep understanding of GMP/GLP regulations.
  • Demonstrated experience with managing project teams, CDMOs and other vendors.
  • Proven expertise in process chemistry and early and late stages API manufacturing and ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products.
  • Ability to work independently in a fast-paced dynamic environment with multiple projects.
  • Must be willing to travel both domestically and internationally approximately 15% - 20% of the time.
  • Must be willing to travel both domestically and internationally approximately 15%
  • Thorough understanding of cGMP requirements for pharmaceutical products. Ability to work
  • Strong analytical, organizational and decision-making skills.
  • Excellent communication skills, both written, verbal

Compensation

  • The annual base salary range for this position is $170,000.00 to $195,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.
  • In addition to base pay, this role is eligible for a discretionary annual bonus.

Benefits

  • Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
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