Senior Director, Commercial Manufacturing, Science and Technology

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the manufacturing of small molecule drug products during the late phase through commercialization at partner CDMOs.

• Act as a technical authority for the transfer of manufacturing processes to a commercial scale.

• Ensure adherence to safety and regulatory standards.

• Supervise process validation, lifecycle management, and ongoing improvement initiatives.

• Anticipate and resolve intricate manufacturing challenges.

• Collaborate with both internal and external stakeholders, including CMC, Quality, Supply Chain, Regulatory, and CDMOs.

• Direct CMC lifecycle activities for commercial drug products, including post-approval change management.

⛳️ Requirements

• PhD, MS, or BS in chemical engineering, pharmaceutical sciences, or a related discipline with a deep understanding of drug product development and manufacturing for small molecule solid oral dosage forms.

• Over 20 years of experience in the biotechnology and/or pharmaceutical industry within a CMC/cGMP environment.

• More than 12 years of experience managing and overseeing CDMOs for cGMP activities related to late-stage and commercial assets.

• Proficient in manufacturing techniques including advanced drug delivery systems aimed at enhancing drug permeability and/or solubility, as well as other processes like blending, granulation, tablet compression, and film coating.

• Extensive experience in outsourcing, vendor selection, and managing CMOs for scale-up, technology transfer, process validation, and commercial manufacturing.

• In-depth knowledge of cGMP requirements for drug product manufacturing and comprehensive drug development guidelines (ICH, FDA, and EMA), along with prior experience in regulatory submissions.

• Exceptional oral and written communication abilities.

• Strong attention to detail and quality, complemented by critical thinking skills.

• Capability to navigate and formulate global regulatory CMC documentation.

• Familiarity with safe and effective laboratory practices.

• Proficiency in general and scientific computer and software applications.

• Willingness to travel up to 30% of the time.

🏝️ Benefits

• We cover 100% of medical, dental, and vision premiums for you and your family.

• Assist in reducing out-of-pocket expenses by funding up to 75% of in-network deductibles.

• A 401(k) matching plan with immediate vesting.

• Generous paid time off policy.

• 12 weeks of fully paid parental leave.

• Paid family and medical leave available for all employees, irrespective of location.

• Company-sponsored short-term disability coverage for up to 20 weeks.

• Additional benefits such as wellness programs, tuition reimbursement, and inclusive family-forming support.