Senior Manager, Drug Substance

The Opportunity:

• Are you a seasoned process chemist who enjoys working on drug substance projects? Do you love working closely with pharmaceutical development teams and external collaborators to seamlessly transition process development and help drug substance scale up and manufacturing efforts?
• In this role, you will be responsible for managing the chemical development and external manufacturing activities of our drug substance, you will have the opportunity to work across the various programs in our pipeline spanning from late research through clinical trials and beyond.

Your Role:

• You will support drug substance development efforts toward IND filing and continue to support the journey from clinical trials to commercialization of our small molecule drug candidates.
• You will collaborate with the Discovery team and support the manufacturing of drug substances for DRF batches.
• You will leverage your technical expertise to lead or co-lead drug substance development programs, overseeing process development, scale-up, and manufacturing activities at global CRO and CDMO partners.
• You will lead technical discussions with CDMOs, troubleshoot manufacturing challenges, and implement data-driven process improvements.
• You will design and develop innovative, scalable, and commercially viable synthetic routes for complex small-molecule APIs.
• We will rely on your regulatory compliance oversight at vendor sites during manufacturing campaigns.
• You will define and implement phase-appropriate control strategies for raw materials and drug substance manufacturing, ensuring robust processes, consistent product quality, and alignment with regulatory expectations.
• You will act as the key technical transfer resource, in implementation of optimized drug substance processes at our vendors.
• You will troubleshoot and solve synthetic, scale-up and manufacturing issues.
• You will author and review/approve specifications, batch records, development reports, manufacturing reports, and other critical technical documents as needed.
• Collaboration is key for this role as you will work with other pharmaceutical development colleagues and external collaborators at CDMOs to advance the project.
• Bring your scientific writing expertise to author and review drug substance sections of regulatory submissions and technical documents, ensuring scientific accuracy and regulatory compliance.
• You will travel domestically and/or internationally to accomplish critical objectives at the vendor’s site, when necessary.

Your Background:

• You should have earned your Ph.D. or equivalent with 5+ years of relevant process development, tech transfer and/or manufacturing experience in pharmaceutical companies or contract manufacturing organizations (CMOs).
• Strong background in synthetic organic chemistry with demonstrated expertise in designing, developing, and optimizing synthetic routes for small molecule APIs.
• First-hand experience in process research, synthetic methodology development, impurity studies, and scale-up on pilot plant.
• Analytical skills should include all modern spectroscopic techniques including NMR experimentation and techniques; IR; mass spectroscopy, ReactIR and UV/Vis; separation techniques including chromatography: HPLC, GC, TLC, flash chromatography, chiral separations; solid state characterizations; gravimetric analysis and titration.
• An expert in cGMP, and has a strong knowledge of ICH, US FDA and EMA quality guidelines.
• At ease with creating high-quality written reports and common technical documents (CTD) sections for use in regulatory submissions.
• An open and articulate communicator who can collaborate effectively with contract laboratories and manufacturing facilities as well as internal staff.
• Excellent planning and organizational skills and the ability of multi-tasking and prioritizing in a highly dynamic environment.
• Demonstrated ability to work independently, prioritize tasks, and make scientifically sound decisions in a fast-paced pharmaceutical/biotechnology environment.
• Prior experience in managing CRO/CDMO is highly desirable but not mandatory.
• Prior experience in developing and applying innovative technologies, such as flow chemistry, biocatalysis, continuous manufacturing, and process analytical technologies (PAT), is highly desirable, not mandatory.

 

Estimated Salary Range: [$122,000 - $174,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

 

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