Principal Scientist — Sterile Drug Product Commercialization

MSD•Upper Gwynedd Township, PA

4d•Hybrid

About The Position

As part of our Company’s Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. The SDPC team is based out of West Point PA, USA with a presence in Carlow, Ireland supporting Irish and European Sterile Drug Product manufacturing sites. The SDPC group is the division’s leader in sterile product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel vaccines, biologics, pharmaceutical products and combination products. The SDPC group supports the growing pipeline of diverse products and evolving technologies. We are seeking an experienced Principal Scientist to advance and commercialize the intravitreal (IVT) pipeline products. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process scale up, transfer and process validation activities at a start-up manufacturing site. This position may require travel up to 25%. Must be able to travel for this position. What you will do:

Requirements

Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with twelve (12) years of required experience; OR Master of Science (M.S.) in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with ten (10) years of required experience; OR Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of required experience
Experienced in sterile drug product fill finish manufacturing practices including working with low volume fills and small batch scale.
Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms as applied in Manufacturing Science and Technology or Technical Operations.
Excellent oral and written communication skills.
Ability to effectively articulate understanding of process science, to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles.
Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes
Experience in Data Analytics and Computer Modeling.
Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products.
Accountability
Biomedical Engineering
Biopharmaceuticals
Biopharmaceutics
Chemical Engineering
Clinical Manufacturing
Communication
Creativity
Cross-Functional Teamwork
Data Analysis
Decision Making
Diversity and Inclusion (D&I)
Downstream Processing
Driving Continuous Improvement
Immunochemistry
Intravitreal Injections
Manufacturing Scale-Up
Mentorship
Microbiology
Molecular Microbiology
Multivariate Data Analysis
Ophthalmology
Pharmacology
Process Characterization

Nice To Haves

Background including comprehensive knowledge and hands on experience in the development of IVT products.
Experienced in intravitreal/ophthalmic manufacturing practices and working practices for low particulate, low bioburden/endotoxin environments.

Responsibilities

Execute and provides oversight to intravitreal product and process design, development, characterization, technology transfer, and robust commercial validation.
Serve on cross functional drug product (DP) working group and supports intravitreal DP activities through filing and Process Performance Qualification (PPQ), site characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
Ensure commercialization program meet requirements related to science, quality, reliability, schedule, and cost.
Provide mentorship, technical oversight, and strategic guidance with respect to intravitreal process optimization.
Uses advanced experience gained on scientific/technical issues to guide others to address complex technical challenges.
Develop a process and product development plan.
Influences decisions related to primary packaging.
Innovate and drive best practices for commercial site tech transfer, facility fit and development of the DP control strategy.
Define the classification of process parameters, performance parameters, operating ranges, in-process controls.
Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
Influence CMC regulatory strategy and author DP CMC sections of filing.
Review regulatory strategy and filing readiness and support preparation for agency meetings.
Author and review regulatory submissions.
Create the best and next practices in-process scale down, parameter finding, site characterization and transfer.
Establish and foster a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.