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Sr Principal Scientist – Sterile Product Development
| Company | Inventing for Life |
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| Location | Linden, NJ, USA |
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| Salary | $187000 – $294400 |
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| Type | Full-Time |
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| Degrees | Master’s, PhD |
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| Experience Level | Senior, Expert or higher |
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Requirements
- Masters with a minimum of 18 years or Ph.D. with a minimum of 12 years of industry experience and a Degree in Chemical/ Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field.
- Strong track record in biologics product development including multiple regulatory filings spanning multiple biologic modalities including mAbs, ADCs, fusion proteins, combinations such as doublet or triplet co-formulations.
- Subject matter expert of process development and process characterization for biologic drug products with proven track record of successful tech transfers to GMP manufacturing sites.
- Significant experience with drying technologies such as lyophilization both as a platform technology to enable speed to clinic and deep fundamental understanding of the process and how to optimize.
- Experience in designing and executing appropriate DOE studies to inform on biologic drug product risks such as oxidation or light exposure.
- Well-versed in QbD principles and have experience applying the QbD tools and principles to drug products in development.
- Strong familiarity with relevant biologic analytical methods and specifications for drug products as well as drug substance downstream formulation considerations.
- Subject matter expert in developing and authoring regulatory filings for combination products of biologic therapeutics.
- Experience, desire and a track record of effective mentorship of junior scientists towards timebound goals.
- Demonstrate scientific leadership in the field of biologics product development.
Responsibilities
- Designing and developing sterile products for injectables and ocular drug products.
- Supporting both early and late-stage development candidates, ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.
- 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.
- Ideating, leading, and championing organizational strategic and innovation objectives aligned with organizational goals.
- Being a change agent for continuous improvement of internal processes contextualizing the broader portfolio outside of their assigned programs.
Preferred Qualifications
- Experience in pharmaceutical sciences, physical pharmacy, physiology, pharmacokinetics, biochemistry, protein sciences, chemical kinetics or transport phenomenon is highly desirable.
- Experience in formulation/process, definition of critical attributes for process scale-up, analytical development and experience with Biologics License Application filing for non-conventional sterile dosage forms including ocular dosage forms or peptide therapeutics, and/or alternate delivery technologies (e.g. high concentration, hydrogels, emulsions, suspensions, injectable depot) is a plus.
