Principal Scientist (Sterile & Specialty Products)

Job Description

The Sterile and Specialty Products (SSP) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.

Our team is looking for a strong candidate for the position of Principal Scientist (R5) within the Biologics product development group.

Primary duties:

• Be a seasoned biologics product developer responsible for designing and developing sterile products for injectable, ophthalmic, and inhaled routes of administration.

• 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 on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.

• Responsible for ideating, leading, and championing organizational strategic and innovation objectives aligned with organizational goals.

• Has prior experience with process scale up, modeling, regulatory filings 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

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Education Minimum Requirement:

•  Masters with a minimum of 12 years or Ph.D. with a minimum of 8 years of industry experience and a Degree in Chemical/ Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field. 

Required Experience and Skills:  

• The candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process development (including mAbs, ADCs, fusion proteins, combinations such as doublet or triplet co-formulations and drying technologies such as lyophilization) reflected through industry experience and external publications and patents.

• The candidate should have experience in designing and executing …