Interius BioTherapeutics · 1 week ago

Sr. Scientist, Drug Product Development

Philadelphia, PA

Full-time

Onsite

Senior Level

5+ years exp

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Responsibilities

Independently lead, design, and execute various steps of viral vector formulation and drug product process, including formulation, filling, freezing and drug product characterization and stability studies.

Plan and lead experimental logistics, including scheduling, preparing/sourcing materials/media/buffers, and other consumables/reagents.

Develop viral vector drug product characterization methodologies including but not limited to particle sizing techniques, flow cytometry, flow imaging and other virus characterization technologies.

Design and conduct studies to select container closure, define storage conditions, dose preparation & administration instructions for pre-clinical and clinical studies.

Provide technical supervision and support people development through direct and/or matrix leadership.

Drive innovation for viral vector formulation and drug product process development including internal and external presentations, IP filings, and evaluation of new technologies.

Be responsible for data collection, management, integrity and accuracy. Analyze and present data at team meetings and write technical reports.

Participate and lead technology transfer of Drug product process and provide oversight as person in plant during manufacturing.

Author and review documents including development reports, pharmacy manual, regulatory filing documents (Pre-IND, IND, IMPD, BLA, MAA) and internal purposes.

Contribute to a culture of scientific excellence and advancement, including knowledge of current landscape and external engagement with CDMOs and other partners.

Demonstrate clear and professional verbal and written communication.

Qualification

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Biological FormulationVaccine DevelopmentViral VectorGMP ProductionProcess DevelopmentCGMP ComplianceProblem-SolvingCollaborationLeadershipCommunicationDeveloping/Evaluating New TechnologiesAuthoring/Reviewing Regulatory FilingsVaccinated Against SARS-CoV2

Required

Ph.D. in Pharmaceutical Sciences or Biochemistry or a related field with at least 5 years of relevant experience OR MS with at least 8-10 years of relevant experience OR a BS with at least 12 years of relevant experience is required.

Demonstrated competency and experience with biological, vaccine or preferably viral vector formulation and drug product development to enable GMP production.

Experience developing drug product processes and procedures and transferring of them to cGMP facilities is required.

Ability to work independently on multiple programs and represent Drug Product at cross-functional teams.

Effective communication skills, collaborative skills and demonstrated leadership in providing integration of activities and delivering information across groups is required.

Preferred

Experience with developing/evaluating new technologies and new platforms to generate new research ideas and initiatives to build intellectual capabilities is preferred.

Experience with authoring and reviewing regulatory filings (IND, IMPD, BLA, MAA) is preferred.

Vaccinated against SARS-CoV2 plus booster.