Senior Manager, Specialized Chemical Development

@ Deciphera Pharmaceuticals

The Role

The Senior Manager, Specialized Chemical Development will support assigned process chemistry activities for drug substance (DS), DS intermediates and starting materials. The initial main focus will be an oligonucleotide project, with opportunities to work on small molecule or other modalities in the future.

The role involves process research, scale-up activities, process definition, Process Performance Qualification (PPQ), and characterization/design-space mapping. It may also include Person in Plant (PIP) oversight of manufacturing processes. Collaboration with Process Engineering during routine manufacturing, technical transfer, PPQ and process improvement initiatives is expected.

This position operates in a virtual (100% outsourced) business model in which the candidate will participate in CDMO selection and oversight, fostering strong business partnerships.

What You’ll Do

• Support and manage process development activities and API scale up for an oligonucleotide project and other assets.
• Critically analyze process and analytical data to resolve development challenges.
• Work on cGMP manufacturing projects involving drug substances, intermediates, and starting materials.
• Collaborate with Quality Assurance, Regulatory CMC, Supply Chain, Process Engineering and external partners.
• Review and author technical documents including Module 3 CTD content and controlled GMP documents.
• Engage in vendor management and CDMO oversight, ensuring technical, regulatory and quality compliance.
• Occasionally represent the Technical Operations organization in meetings with regulatory authorities like the FDA and EMA.

Qualifications

• PhD plus 3+ years of experience, or Bachelors/Masters plus 8+ years in pharmaceutical synthetic process research, development and commercialization.
• Previous oligonucleotide experience is strongly preferred.
• Familiarity with analytical techniques and manufacturing operations specific to oligonucleotides is desirable.
• Proven track record working on drug substance programs in a 100% outsourced environment.
• Strong technical writing, project management, and decision-making skills.
• Ability to travel up to 25% domestically and internationally.
• Proficiency with software such as MS Word, Excel, PowerPoint, SciFinder, ChemDraw, and JMP.

Additional Information

The role is based in Waltham, Massachusetts, although remote candidates will be considered. Occasional domestic and international travel up to 25% is required.

Deciphera Pharmaceuticals offers a competitive compensation and benefits package including salary, annual bonus, long-term incentives, and comprehensive benefits such as medical, dental, and vision coverage with a 401(k) plan.

Key skills/competency

• Process Chemistry
• Oligonucleotide
• cGMP
• Scale-up
• CDMO
• Technical Writing
• Regulatory
• Vendor Management
• Project Management
• Analytical Techniques