R391318 Scientist, Sterile Drug Product Commercialization-2

Job description 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 Large Molecule and sterile Pharmaceutical products. It is the division's leader in sterile product and process development, responsible for commercialization activities including process development, 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 Biologics and Pharmaceutical products and combination products. The Scientist is a drug product commercialization scientist/engineer, responsible for these key activities within the Sterile Drug Product Commercialization department. Our engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. This position may require travel up to 10%; Must be able to travel for this position. This position required to be on site fours days per week. Responsibilities for this position include but are not limited to the following: Serve on drug product (DP) process characterization teams, designing and executing multivariate product and process development studies. Support cross functional DP working groups and also 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. Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost. Responsible for the design and execution of DP commercialization studies, new product introduction and process validation at commercial sites. Contributes to development of fit-for-purpose scale-down models. 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. Contributes to establish and foster a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion. Minimum Education Requirements B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 2 years of relevant experience; or Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field

Required Experience and Skills:

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.

Preferred Experience and Skills:

Technical experience in large molecules drug product process characterization, fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial. Knowledge of combination product development. Working knowledge of regulatory requirements or current Good Manufacturing Practices(cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations. 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. Working understanding of analytical methods to characterize biologics and other sterile drug products.

Required Skills:

Biochemistry, Biochemistry, Biopharmaceuticals, Biopharmaceutics, Cell Culture Techniques, Clinical Manufacturing, Data Analysis, Detail-Oriented, Downstream Process Development, Experimentation, Good Manufacturing Practices (GMP), Immunochemistry, Interdisciplinary Collaboration, Maintenance Supervision, Microbiology, Multivariate Data Analysis, New Product Development, Pharmaceutical Process Development, Platform Engineering, Process Scale Up, Process Validation, Product Formulation, Statistical Process Control (SPC), Technical Writing, Technology Transfer {+ 1 more}

Preferred Skills:

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: EEOC Know Your Rights

EEOC GINA

Supplement 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 The salary range for this role is $87,300.00 - $137,400.00 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 . You can apply for this role through (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:

No relocation

VISA Sponsorship:

No Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable Shift:

1st -

Day Valid Driving License:

No Hazardous Material(s): n/a

Job Posting End Date:

05/21/2026 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.

Requisition ID:

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