Principal Scientist – Drug Product Development

Principal Scientist – Drug Product Development

Requirements

• Ph.D. with 8+ years of industry experience, or a Master’s degree with at least 12 years in Chemical/Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.
• Strong track record in biologics product development, including multiple regulatory filings across modalities such as monoclonal antibodies, ADCs, fusion proteins, and combination products.
• Expertise in process development and characterization for biologic drug products, with a proven record of successful technology transfers to GMP manufacturing sites.
• Demonstrated external presence through scientific publications and/or patents.
• Experience designing and executing DOE studies to assess risks such as oxidation and light exposure in drug products.
• Strong knowledge of Quality by Design (QbD) principles and experience applying QbD tools in development.
• Familiarity with analytical methods and specifications for biologic drug products and formulation considerations for drug substances.
• Ability to support CMC and program teams as a subject matter expert, including technical due diligence and CRO/CMO assessment and management.
• Skilled in authoring, reviewing, and approving technical protocols, reports, and GMP/quality documentation.
• Strong understanding of current regulatory expectations and emerging technologies in drug product and combination product development.
• Collaborative mindset with the ability to work across cross-functional teams and disciplines.
• Strong problem-solving skills and ability to work independently in a fast-paced, startup environment.
• Effective communication skills; able to present complex data clearly to a range of audiences.
• Proactive and organized, with the ability to manage multiple tasks, timelines, and priorities.
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Experience working with contract research organizations (CROs).

Responsibilities

• Be a seasoned biologics product developer responsible for designing and developing sterile products for injectables and ocular drug products.
• Support both early and late-stage development candidates that will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.
• Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small group of scientists during product development to ensure completion of key milestones and laboratory / regulatory documentation.
• Active strategic and technical leadership to influence program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.
• Outstanding communication skills and the ability to clearly articulate risks and trade-offs experienced within product development to appropriate governance venues and management.
• Responsible for ideating, leading, and championing organizational strategic and innovation objectives aligned with organizational goals.
• Has subject matter expertise with process scale up, modeling, regulatory filings for commercialization and/or driving key capability evaluation/ build.
• Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.
• Proven demonstration of leadership behaviors.
• Be a change agent for continuous improvement of internal processes contextualizing the broader portfolio outside of their assigned programs.

Preferred Qualifications

• Preferred experience in lyophilization and combination drug product development with a good understanding of the inter-relationship among formulation parameters, process parameters, device performance, product delivery and quality.
• Experience developing and submitting regulatory filings for biologic combination products (e.g., IND, BLA, MAA), including response preparation for Health Authorities.