Job Information
Merck Associate Principal Scientist, Sterile Drug Product Commercialization in West Point, Pennsylvania
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 engineers.
Skills in driving strategic initiatives that enhance efficiency and speed in commercialization processes.
Strong verbal and written communication skills for collaboration with internal and external stakeholders.
Preferred Skills and Experience:
Advanced knowledge in scientific and technical issues related to drug product commercialization.
Ability to innovate and drive best practices in process development and commercialization.
Experience in developing comprehensive process and product development plans.
Knowledge of PPQ readiness and execution, including Pre-Approval Inspection (PAI) readiness.
Knowledge of primary packaging and combination product design.
Experience in developing and validating fit-for-purpose scale-down models and platform engineering models.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
04/25/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R344302