Overview:
The Associate Director I Director of Biopharmaceutical Development is a key leader within Sequel Pharma and will be responsible for the development and supply of recombinant proteins, and other biologics including mono- and multi-specific antibodies, and antibody fragments from late-stage discovery through clinical proof of concept and market approval. This position requires a skilled domain expert in biologics process development, IND-enabling studies and GMP campaigns. The ideal candidate will influence cross-functional project teams and manage CROs and CDMOs both domestically and globally.
Key Responsibilities:
- Lead the process development, characterization and validation studies for biologics projects at the IND-enabling stage through human proof of concept and market approval, across domestic and international CROs and CDMOs.
- Oversee the development of robust and scalable upstream and downstream processes for the expression, harvesting and purification of recombinant proteins and monoclonal antibodies.
- Develop and qualify analytical methods for product characterization, stability testing and GMP release in accordance with regulatory requirements.
- Develop drug product formulations to achieve the desired stability and biologic delivery characteristics in accordance with the target product profile.
- Actively manage the development activities at CDMOs for preclinical and clinical projects including the delivery of GLP tox batches and GMP batches for clinical studies, review development report and batch records.
- Influence CMC regulatory strategy and author/review CMC sections for regulatory filings and responses to regulatory questions.
Qualifications:
- PhD in Chemical Engineering, Biomedical Engineering or Biological sciences, with a minimum of 7 years industry experience or a BS/MS with a minimum of 10 years' experience.
- Hands on experience with process development and scale-up for clinical manufacture including the manufacture of products according to cGMP.
- Domain Expert in either upstream/downstream processing, analytical method development or biologics formulation.
- Strong knowledge of analytical techniques and control strategies for biologics development and manufacture, with particular focus on recombinant proteins.
- Ability to communicate clearly and effectively with various stakeholders, the capability to make timely and informed decisions sometimes with incomplete data, the skill to cultivate a collaborative and inclusive work environment and the ability to think critically and strategically.
- Experience of effectively managing development activities at external CROs.
- Knowledge of regulatory requirements in ICH, US and EU and experience at preparing and reviewing CMC documentation for regulatory submissions considered a plus.
Location: Remote
Expected Salary Range: $150,000 to $170,000 (Compensation will be commensurate with experience and expertise.)
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