Associate Principal Scientist, Sterile Drug Product Commercialization

Job Description

As part of Our Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for Vaccines, Biologics, and sterile pharmaceutical products. It 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, and pharmaceutical products and combination products.

The Associate Principal Scientist is an experienced drug product commercialization scientist/engineer, accountable for end-to-end leadership for these key activities within the Sterile Drug Product Commercialization department.  As a member of the Process Engineering group, the individual also has a key focus on driving excellence for our process scale up, transfer and validation activities.

Accountabilities and Responsibilities for this position include but are not limited to the following:

• Leads and/or serves on cross functional drug product (DP) working groups and manages DP  development activities from late phase through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
• Development and implementation of process /product development plans, including experimental design execution logistics, data analyses to drive program milestones through driving internal governance and regulatory agency filing  Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Drives strategic initiatives (technical and/or business process related) in the department and with partner groups, that enable more efficient and rapid commercialization of innovative products
• Provides mentorship, technical oversight and strategic guidance to team members. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues. 
• Responsible for the design and execution of DP development and commercialization studies, new product introduction and process validation at commercial sites.
• Ensures fit-for-purpose scale-down models are developed and employed. Establishes and validates platform engineering and scientific models for sterile product and process commercialization.
• Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy.  Includes the classification of process parameters, performance parameters, operating ranges, in-process controls.  Drives and influences process demonstration and qualification (PPQ) and shelf-life strategies.
•  Lead tech transfer working group to manage activities across Sending Unit, receiving Unit, to ensure success of TT

Education Minimum Requirement and Experience:

• Bachelor of Science (BS) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with ten (10) years in sterile product development and commercialization processes; OR
• Master of Science (MS) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with eight (8) years in sterile product development and commercialization processes; OR
• PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with four (4) years in sterile product development and commercialization processes

Required Skills and Experience:

• Expertise in the development and commercialization of sterile drug products, including vaccines and biologics.
• Proficiency in process scale-up, technology transfer, and process validation activities.
• Experience in authoring regulatory submissions and ensuring compliance with regulatory standards.
• Ability to develop and execute process characterization plans and registration stability studies.
• Knowledge of tech transfer control strategies and best practices for commercial site tech transfer.

• Experience leading cross-functional drug product working groups and managing drug product activities.
• Ability to provide mentorship and technical oversight to junior scientists and engi