Associate Principal Scientist, Sterile Drug Product Commercialization Full-time

Associate Principal Scientist

As part of our Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides technical process leadership and laboratory expertise for late-stage and commercial sterile drug products, including vaccines, biologics, and pharmaceutical and combination products. The group leads sterile product and process development activities across the division, supporting accelerated and science-driven commercialization of a growing and diverse pipeline.

SDPC is responsible for end-to-end commercialization activities, including process scale-up, technology transfer to internal and external manufacturing sites, process validation, regulatory submission authorship, and support of complex manufacturing investigations. The team establishes the scientific, engineering, and process knowledge required to successfully advance products from development through launch and post-approval manufacturing.

We are seeking an Associate Principal Scientist to serve as a drug product working group lead, accountable for advancing and commercializing pipeline products. In this role, the Associate Principal Scientist will drive excellence in drug product process scale-up, technology transfer, and process validation, with a particular focus on readiness and execution at a start-up manufacturing site.

Responsibilities

• Lead and/or serve on cross-functional biologics drug product (DP) working group and manage 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.
• Design and execute DP development and commercialization studies, new product introduction, and process validation at commercial sites.
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Monitor performance and recommend schedule changes, cost adjustments, or resource additions.
• Develop a process and product development plan. Influence decisions related to primary packaging and combination product design as needed.
• Drive strategic initiatives (technical and/or business process related) in the department and with partner groups, enabling more efficient and rapid commercialization of innovative products.
• Provide mentorship, technical oversight, and strategic guidance to other team members. Use advanced experience gained on scientific/technical issues to guide others to address non-routine and/or difficult issues.
• Ensure fit-for-purpose scale-down models are developed and employed. Establish and validate platform engineering and scientific models for sterile product and process commercialization.
• Innovate and drive 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. Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
• Influence CMC regulatory strategy and be accountable for DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparations for agency meetings. Author and review regulatory submissions.
• Drive continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
• Establish and foster a culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, and inclusion.
• Provide a regular summary of progress against development plan, key programs and technical risks and risk level, mitigation strategies, and how success will be determined.
• Ensure fit-for-purpose process scale down, parameter finding, scientific models, site characterization, and transfer are employed.

Qualifications

Required

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with ten (10) years of relevant experience; or
• M.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of relevant experience; or
• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with four (4) years of relevant experience

Preferred

• Previous experience in a drug product working group lead role
• Experience in biologics drug product fill finish process optimization, scale-up, and technology transfer of sterile products to pilot/commercial.
• Experienced in sterile drug product fill finish manufacturing practices.
• Experience with late-stage commercialization of biologics programs
• Working 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.
• Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles, and authoring and reviewing regulatory documentation.
• 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
• Demonstrated problem-solving skills and competency in technical writing
• Project management and activities management skills (dashboards, activity trackers)
• Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.

This position requires 25% travel.

Required Skills: Adaptability, Biochemistry, Biopharmaceutical Industry, Bioprocessing, Chemical Engineering, Data Analysis, Decision Making, Detail-Oriented, Diversity and Inclusion (D&I), Drug Product Development, GMP Compliance, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Microbiology, Multivariate Data Analysis, New Product Introduction Process, Process Improvements, Process Scale Up, Product Development, Project Management, Protein Purifications {+ 5 more}

Preferred Skills:

The 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.