Job Description

Associate Principal Scientist, Vaccine Sterile Drug Product Commercialization

As part of our 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. We are seeking an experienced Associate Principal Scientist to advance and commercialize our biologics pipeline program. This role will focus on driving excellence in process characterization, scale-up, transfer, and process validation activities. Join us to make a significant impact on the commercialization of innovative health solutions.

Responsibilities

• Lead and/or serve on cross-functional Vaccine drug product (DP) working groups to support early and late pipeline programs.
• Partner with early development vaccine program teams to ensure that commercial product definition and process definitions align with manufacturing capabilities and robustness objectives.
• Lead 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.
• Drive strategic initiatives (technical and/or business process related) with partner groups to enable more efficient and rapid commercialization of innovative products.
• Provide mentorship, technical oversight, and strategic guidance to employees, using advanced experience to guide others in addressing non-routine and/or difficult issues.
• Design and execute DP development and commercialization studies, new product introduction, and process validation at commercial sites.
• Ensure fit-for-purpose scale-down models are developed and employed, and validate platform engineering and scientific models for sterile product and process commercialization.
• Influence CMC regulatory strategy and be accountable for DP CMC sections of filing, reviewing regulatory strategy and filing readiness, and supporting 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, innovation, learning, empowerment, diversity, and inclusion.

Qualifications

Required

• 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
• Experience with drug product process development, optimization, and/or process characterization of vaccine modalities such as conjugates, LVV, VLP, subunit, adjuvants
• Working understanding of analytical methods to characterize vaccines
• Understanding 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 principles
• 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, with the ability to effectively articulate understanding of process science to drive decision-making, impact assessments, and design of studies 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 scales

Preferred

• 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 Application

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

Required Skills:

Accountability, Accountability, Adaptability, Biochemistry, Biologics License Application (BLA), Biomedical Engineering, Biopharmaceuticals, Biopharmaceutics, Bioprocessing, Data Analysis, Decision Making, Deep Learning, Detail-Oriented, Fill and Finish, Immunochemistry, Machine Learning (ML), Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Microbiology, Multivariate Data Analysis, Platform Engineering, Process Improvements {+ 9 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

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”.

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

03/31/2026

*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.