Associate Principal Scientist, Sterile Drug Product Commercialization Full-time NEW

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 our Lab Excellence Lead, accountable for lab operations and capability build. In this role, the Associate Principal Scientist will drive excellence in experiment execution, lab utilization, lab safety, and compliance.

The other main aspect of this role will be to support and advance our late-stage pipeline. Depending on the candidate experience and department needs, the individual may either support drug product tech transfer (as a Sending Unit Lead) or lead workstreams associated with definition and implementation of our Biologics Commercial Platform for drug product.

Responsibilities:

• In a matrixed (dotted-line) relationship, provide leadership to staff responsible for Lab Operations and Lab Excellence. This includes driving a culture of safety & compliance, assessing new capabilities, and introducing new equipment. Mentor / coach scientists to support right-first-time execution and staff development.
• Drive strategic initiatives (technical and/or business process related) in the department and with partner groups, enabling implementation of platform manufacturing processes to drive efficient and rapid commercialization of innovative products.
• Drive continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
• Lead and/or serve on cross-functional biologics drug product (DP) Tech Transfer Team, responsible as the Sending Unit Lead for New Product Introduction (NPI). The potential scope of work includes the tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch, and post‐launch support.
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Monitor performance and recommend schedule changes, cost adjustments, or resource additions.
• 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.
• 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.
• Foster a culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, and inclusion.

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

Experience in biologics and or vaccines drug product fill finish process optimization, scale-up, and technology transfer of sterile products to pilot/commercial is required.

Preferred:

• 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.
• Strong foundation in compliance principles related to lab operations, with a focus on Data Integrity.
• Experience with Lean-Six Sigma principles, including 5S.
• 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.
• 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 4 days per week on-site and 25% travel.

Required Skills: Biologics, Biopharmaceutical Industry, Biopharmaceuticals, Bioprocessing, Immunochemistry, Manufacturing Scale-Up, Mentorship, New Product Introduction (NPI), Protein Purifications, Regulatory Requirements, Technology Transfer, Vaccine Development

Preferred Skills:

This position is for US and Puerto Rico Residents Only. Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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.