Associate Principal Scientist, Engineering – Vaccine, Sterile Drug Product Commercialization Full-time

Associate Principal Scientist, Vaccine, Sterile Drug Product Commercialization

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 late-stage 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.

We are seeking an experienced Associate Principal Scientist to advance and commercialize biologics pipeline program. As a member of the biologics drug product team, the Associate Principal Scientist will have a key focus on driving excellence in process characterization, scale up, transfer and process validation activities.

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

• Leads and/or serves on cross functional Vaccine drug product (DP) working groups to support early and late pipeline programs.
• Partner with early development vaccine program teams to ensures that commercial product definition and process definitions align with manufacturing capabilities and robustness objectives
• Leads DP activities 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.
• Drives strategic initiatives (technical and/or business process related) with partner groups, that enable more efficient and rapid commercialization of innovative products
• Provides mentorship, technical oversight and strategic guidance to employees. Uses advanced experience gained on scientific/technical issues to guide others to address non routine and/or difficult issues.
• 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.
• Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory submissions.
• Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
• Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.

Travel:

This position may require travel up to 25%; Must be able to travel for this position.

Position Qualifications:

• B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
• Master's degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience; or
• Ph.D. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 4 years of relevant experience

Required Experience and Skills:

• Experience with drug product process development, optimization, and/or process characterization of vaccines modalities such as conjugates, LVV, VLP, subunit, adjuvants)
• Working understanding analytical methods to characterize vaccines
• Understanding of knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
• Understanding of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principle
• Experience with at scale vaccine drug product manufacturing and fill finish operations
• Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
• Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
• Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment
• Experience in drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial

Preferred Experience and Skills

• Operations experience in the manufacturing of potent and sterile drug products, at pilot and/or commercial scale.
• 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, Computer Modeling, and Digital Applications

Required Skills:

Biochemistry, Biological Engineering, Biologics, Biopharmaceuticals, Bioprocess Engineering, Bioprocessing, Biotechnology, Chemical Engineering, Commercialization, Decision Making, Drug Product Manufacturing, Manufacturing Scale-Up, Process Improvements, Process Scale Up, Process Transfers, Protein Purifications, Regulatory Submissions, Shop Floor Management, Technical Writing, Technology Transfer, Vaccine Development, Virus Production

Preferred Skills:

Salary range for this role is $142,400.00 – $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.