- Manage all activities related to small molecule drug substance development and manufacturing.
- Oversee the drug substance process chemistry development, scale up, and manufacturing for GLP studies and GMP manufacturing at CDMOs.
- Develop manufacturing processes that are scalable, safe, cost-effective, and environmentally friendly.
- Address complex issues involving salt, polymorph and particle size attributes, synthesis, reaction kinetics, process safety, impurity profile management, processibility, and equipment design, applying industry best practices as appropriate.
- Partner with assigned groups to facilitate candidate nomination.
- Resolve synthesis, process design, production equipment, and scale-up challenges, with deep knowledge of fundamental chemistry and engineering principles.
- In close collaboration with executive management, define timelines, production scale, and related budgets to support all development candidates.
- Work collaboratively with Quality Assurance and Regulatory to review and approve analytical documents, stability results, manufacturing batch records and regulatory documents pertaining to drug substance.
- Write assigned sections of regulatory documents pertaining to drug substance.
- Serve as the internal expert on CMC technical information, guidance, and support.
- Deliver on other related projects as assigned.
- Masters degree in Chemistry or related field in life sciences; Ph.D. preferred.
- 10+ years of postdoctoral research experience and/or experience in small molecule drug development and manufacturing in biotech and/or pharma industry.
- Experience with process chemistry development, scale-up, tech transfer, drug substance characterization and working with CDMOs.
- Experience in cGMP manufacturing, leveraging, and managing US and International CRO/CDMOs for the manufacture of regulatory starting materials and drug substances.
- Experience guiding the CMC sections/quality modules for regulatory submissions and knowledge of current regulations.
- A thorough understanding of ICH guidelines, GMPs, and relevant regulatory requirements.
- Experience with quality by design, process validations and statistical design of experiments (DOE) a plus.
- Experience with both early and late-stage process development a plus.
- Highly organized and detail oriented with a passion to deliver quality results.
- Excellent verbal and written communication skills, with experience translating complex concepts for various audiences.
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit.
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well.
- Evidence of "hands-on" experience and expertise.
- Proven and successful track record as a team-player and collaborator in small working environments.
- Highest levels of professionalism, confidence, personal values and ethical standards.
- Ability to travel domestically and/or internationally as necessary
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Director / Senior Director, Process Chemistry - Cambridge, United States - Alkeus Pharmaceuticals, Inc.
Description
About Alkeus Pharmaceuticals:
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at
Position Summary:
We are seeking an exceptional Sr./Director, Process Chemistry to lead the development of robust and scalable manufacturing processes. As a key member of the Technical Operations team, the Sr./Director brings deep expertise in process chemistry and collaborates with cross functional teams, providing oversight of CDMOs for process chemistry, scale-up, and drug substance manufacturing.
This is an exciting opportunity to be at the forefront of our mission and make a significant impact on the growth and direction of Alkeus Pharmaceuticals.
Primary Responsibilities:
Qualifications:
Education and Certification
Work Experience
Skills and Key Success Factors
Other Relevant Information:
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage candidates of all backgrounds to apply.
To apply, please submit your resume to: ,please include the position in the subject line
