Job Details

Overview

Associate Director, Chemical Development & Manufacturing

We are seeking a scientist who cares about this important work and is driven to connect to our mission of helping patient communities. The chemist will be immersed into all aspects of small molecule development from process design to cGMP manufacturing. The role will lead and support activities and act as the Subject Matter Expert to solve technical challenges and develop sustainable processes to provide an uninterrupted drug supply to patients. The chemist will collaborate and gain leadership experience in data driven process development, CDMO management, production, CMC, and regulatory submissions.

Responsibilities

• Solve technical issues relating to external drug substance manufacturing by providing technical leadership within the chemical development group
• Responsible for drug substance process design, optimization, scale-up, technology transfer, and validation with a focus on clinical manufacturing; ensure relevant data is captured in reports provided by external CROs/CMOs
• Serve as the drug substance technical lead on a CMC sub-team and project leadership within chemical development and DS project point of contact with CDMOs
• Identify key knowledge gaps and execute plans to ensure our process understanding is commensurate with a given program's stage of clinical development

Qualifications

• MS or PhD in organic chemistry or chemical engineering with 10+ years (MS) or 6-10+ years (PhD) of industry experience
• Must have knowledge and understanding of organic chemistry including expert hands-on experience
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment
• Experience authoring regulatory documentation in support of clinical trials (IND, QOS, IMPD, Briefing Booklets, etc.) and submissions (NDA and MAA)
• Strong verbal, written, and interpersonal communication skills
• Demonstrated proficiency to manage timelines by effective prioritization to timely meet departmental and corporate goals

Preferred Qualifications

• Experience managing CROs and CMOs
• Experience with and demonstrated application of advanced technologies to enable and accelerate development including flow chemistry, computational modeling, PAT, DOE, and/or process modeling
• Previously served as a drug substance lead/SME for clinical development programs
• Ability to travel quarterly