Associate Director, Early Stage API Manufacturing (Remote)

Full time @Apellis in Life Sciences
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Job Detail

  • Job ID 84214
  • Job Type Full-time
  • Experience 8 Years +
  • Industry Life Science
  • Qualifications Ph.D.

Job Description

Position Summary:

The AD of Early-Stage API Manufacturing is responsible for design & manufacturing of novel oligonucleotide and oligonucleotide derivatives for applications in the brain, eye and other tissues. They are part of the CMC organization and collaborate closely with the Discovery Chemistry team and the Research Indication Teams. They ensure manufacturing and supplies of test articles for preclinical and early clinical testing according to specifications, timelines and budget.

To be successful in this scientific role, the ideal candidate must have demonstrated track record in chemical synthesis of oligonucleotide and its derivatives (e.g. chemical modification with peptides, fatty acids and other moieties) and drug process development paired with fundamental knowledge of regulatory and GMP quality requirements. A strong track record in working with external vendors is required. Expertise with other therapeutic modalities, e.g. peptide synthesis or expertise in the field of ophthalmology or CNS drug development is an advantage.

Key Responsibilities Include:

  • Accountable for timely availability of oligonucleotide API for research, preclinical and initial clinical studies within agreed upon quality, budget and timelines.
  • Ensure stage appropriate quality and specification of manufactured and released oligonucleotide drug substances for delivery to sensitive organs such as eye and brain.
  • Identify, contract and oversee external service providers to develop synthetic processes and analytical procedures.
  • Contribute to synthetic route scouting, technology selection, in-process controls, characterization of intermediates and stability of complex compounds of oligonucleotides as well as other therapeutic modalities.
  • Author or oversee writing of documentation supporting an US IND or local equivalent.
  • Represent CMC at cross-functional research indication team meetings
  • Promote a culture of collaboration, cooperation, effective communication and cross-functional problem-solving to become a high-performing team.

Education, Registration & Certification:

  • PhD Chemistry or advanced degree with multiple years of experience in (modified) oligonucleotide synthesis in industry.

Experience:

  • In depth knowledge of analytical method development and testing of oligonucleotides for characterization and release.
  • Experiences in synthesis and purification of chemically modified oligonucleotides with e.g. peptides, fluorophores or small molecules is a plus.
  • Experience with peptide synthesis, enzymatic ligation, bacterial or mammalian cell culture is a plus
  • Experiences in the field of drug substance or drug product development for ophthalmic or CNS indications is a plus
  • Strong problem-solving skills, self-motivated with ability to work and react well to a changing environment in early-stage development
  • Demonstrated success managing timelines and budget expectations in the late nonclinical to early clinical CMC space
  • Ability to effectively collaborate with others; strong team player that has a customer service approach and is solution oriented
  • Ability to effectively manage and build great relationships with external collaborators
  • Attention to detail and a hands-on approach towards project management tasks such as compilation of reports and presentations, dashboards and budget tracking

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

  • Travel estimated at 15%.

 

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