Principal Scientist, Sterile Product Development

MSD•Rahway, NJ

4d•Hybrid

About The Position

The Sterile Product Development (SPD) 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

Requirements

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.
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
experience in designing and executing appropriate DOE studies to inform on biologic drug product risks such as oxidation or light exposure
experience in QbD principles and experience applying the QbD tools and principles to drug products in development
experience authoring regulatory filings for sterile dosage forms especially biologics (liquid/ lyophilized/ complex systems)
experience with technology transfer to facilitate scale-up of early phase and late phase biologic drug product manufacturing processes to GMP production facilities
strong familiarity with relevant biologic analytical methods and specifications for drug products as well as drug substance downstream formulation considerations
experience in developing combination products for 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
Accountability
Adaptability
Biochemistry
Biopharmaceuticals
Cell Culture Process Development
Cell Line Development
Combination Products
Data Analysis
Design
Finite Element Analysis (FEA)
GMP Compliance
Immunochemistry
Innovation
Innovative Thinking
Leadership Mentoring
Machine Learning (ML)
Medicinal Chemistry
Multitasking
Pharmaceutical Process Development
Pharmaceutical Sciences
Physiology
Professional Collaboration
Professional Networking
Quality by Design

Nice To Haves

Experience in pharmaceutical sciences, physical pharmacy, physiology, pharmacokinetics, biochemistry, protein sciences, chemical kinetics or transport phenomenon is highly desirable.
Experience in biologics process development and process characterization to enable efficient tech transfer to manufacturing sites.
Experience in modeling such as Monte Carlo simulations to predict manufacturing success
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.

Responsibilities

designing and developing sterile products for injectable, ophthalmic, and inhaled routes of administration
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 on 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