Principal Scientist, Early Stage Pharmaceutical Development

Full time @Apellis in Life Sciences
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Job Detail

  • Job ID 84212
  • Experience 8 Years +
  • Industry Life Science
  • Qualifications Ph.D.

Job Description

Position Summary:

The Principal Scientist of Early Stage Pharmaceutical Development is responsible for developing early stage drug product formulations for Apellis’ research compounds for use in preclinical and early clinical studies. They are based in Apellis’ Innovation Laboratory in Watertown and will use an efficient combination of in house formulation development activities paired with capabilities from external vendors to ensure timely availability of drug product for preclinical or clinical studies within agreed upon budget and quality.

This role will interact extensively with team members within Research, Technical Operations, Preclinical and Clinical Development organizations, and it is supported by a network of internal and external CMC consultants. The ideal candidate must have product development experience with peptides, proteins and oligonucleotides, experience in evaluating product stability and other quality attributes, coupled with working knowledge of excipient and formulation choices for nonclinical and clinical drug delivery. Experiences in ophthalmic or CNS drug product development is a plus.

Key Responsibilities Include:

  • Ensure development and availability of drug products for preclinical and early clinical evaluation within agreed upon specifications, timeline and budget
  • Contributes to the development of the stage appropriate quality target product profile and ensure quality of manufactured and released drug product.
  • Develop analytical tools required to demonstrate the purity and stability of the chemical or biological entities, as well as interpretation of data for evaluation of product consistency, for biologics and small molecule therapeutics.
  • Identify, contract and oversee external service providers to supplement internal development activities to enable efficient drug product development and manufacturing of test articles.
  • Author or review of CMC regulatory documents for global submissions
  • Represent CMC at cross-functional project 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 in Chemistry, Pharmacy or other relevant discipline or MSc with multiple years of early stage drug product development in the biotech/pharmaceutical industry

Experience:

  • In depth expertise in early stage product development of biologics, incl. formulation and analytical method development required. Additional expertise in small molecule or other modality formulation development a plus.
  • Pharmaceutical product development in the field of Ophthalmology or CNS indications is a plus
  • Development of drug-device combinations is a plus
  • Exceptional organizational skills with the ability to multi-task and prioritize assignments, strong problem-solving skills, self-motivated with ability to work under pressure
  • Working knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for GMP operations
  • Scientific creativity, independent thought, and ability to effectively collaborate with others
  • Strong team player that has a customer service approach and is solution oriented
  • Ability to work in a fast-paced environment and resilience to change
  • 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 a role that requires moderate physical demand as required in a laboratory setting. This may include the ability to handle and lift equipment, conduct work standing and wearing personal protective equipment as may be required on a frequent basis.

This job may also operate frequently in the office environment and with standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

  • Travel estimated at 15%.

 

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