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Senior Manager/ Associate Director of Process Chemistry

Cambridge, MA

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary:

Alkeus Pharmaceuticals is seeking a passionate synthetic chemistry expert to aide in advancing our mission of making a difference in patients' lives. The Senior Manager/ Associate Director of Process Chemistry will oversee the development of scalable manufacturing processes for small-molecule drug candidates, reporting to the Head of Drug Substance. This key CMC team member will collaborate extensively with drug product and analytical chemistry teams, leveraging deep expertise in synthetic chemistry and process development.

Primary Responsibilities:

  • Lead small-molecule drug substance development and manufacturing activities.
  • Oversee process chemistry development, scale-up, and GLP/GMP manufacturing at CDMOs.
  • Develop scalable, cost-effective, safe, and environmentally sustainable manufacturing processes.
  • Address challenges related to synthesis, reaction kinetics, impurity control, process safety, and equipment design using industry best practices.
  • Define timelines, scales, and budgets for development projects in partnership with the Head of Drug Substance.
  • Collaborate with Quality Assurance to review and approve batch records and regulatory documentation.
  • Author and review drug substance sections in regulatory documents.
  • Provide technical guidance and support across CMC and cross-functional teams.
  • Contribute positively to the culture at Alkeus and uphold company policies.

Skills and Qualifications:

  • Ph.D. or M.S. in synthetic chemistry with 10+ years of experience in small-molecule, phase appropriate drug development and manufacturing.
  • Expertise in process chemistry development, scale-up, tech transfer, and working with CDMOs.
  • Passion for synthetic chemistry and the mechanisms that drive the formation of key intermediate and final products.
  • Understanding and compassionate leadership when directing teams.
  • Proficiency in cGMP manufacturing and knowledge of US and international regulatory requirements.
  • Experience with regulatory submissions (IND/NDA), quality by design (QbD), and process validation (PV).
  • Strong interpersonal skills with the ability to work in a cross-functional matrix environment.
  • Excellent written and verbal communication skills.
  • Experience in Analytical chemistry as it pertains to DS manufacturing.
  • In-depth knowledge of ICH guidelines, GMPs, and regulatory standards.
  • Ability to travel domestically and internationally as needed.
  • Commercial experience a plus.
  • Innovative, collaborative, and dynamic chemistry expert ready to thrive in a fast-paced startup environment and contribute to the success of Alkeus Pharmaceuticals.

Skills and Key Success Factors: 

  • Entrepreneurship spirit with a passion to build, learn and evolve with the team.
  • Highly organized and detail oriented with a passion to deliver quality results.
  • 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 and aptitude to manage ambiguity and adaptability to change
  • Emphasize the need for self-motivation and the ability to work independently

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.

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