Sr Principal Scientist, Sterile Product Development

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 Senior Principal Scientist within the Biologics product development group.

Primary duties:

• 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.

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Education Minimum Requirement:

• 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. 

Required Experience and Skills:  

• The candidate should have a 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
• Strong external presence reflected through multiple external publications and patents.
• The candidate should have experience in designing and executing appropriate DOE studies to inform on biologic drug product risks such as oxidation or light exposure  
• The candidate should be well-versed in QbD principles and have experience applying the QbD tools and principles to drug products in development
• The candidate should have 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
• The candidate should have experience, desire and a track record of effective mentorship of junior scientists towards timebound goals.
• The candidate should