Job Description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough.

The Senior Specialist, GMP Process Operations, serves as a technical expert and operational leader within the upstream bioreactor operations team. This role is hands-on, providing both direct process execution and leadership across multiple manufacturing campaigns. The Senior Specialist applies deep technical knowledge of bioreactor systems and GMP compliance to ensure successful production of clinical materials, effective technology transfer of new processes and continuous improvement of manufacturing operations.

Key Responsibilities:

• Lead and execute GMP bioreactor operations across multiple scales ranging from benchtop to 2000L in stainless steel, glass, and single-use systems.

• Direct and coordinate upstream campaign teams ensuring safety compliance and schedule adherence.

• Serve as a subject matter expert for bioreactor operations, including system design, process control, and troubleshooting.

• Provide technical leadership in deviation investigations CAPA implementation and change control activities.

• Partner with process development, engineering and quality to introduce, scale, and optimize new processes in the GMP manufacturing environment.

• Drive continuous improvement initiatives related to process robustness, equipment reliability, and operational efficiency.

• Mentor and training Specialists and Associate Specialists in technical execution, GMP documentation, and problem-solving methodologies.

• Maintain accurate and compliant documentation including batch records, logbooks, and deviation reports.

• Promote a strong safety and quality culture through example and engagement.

#PRD

Education:

• Bachelor’s degree in biology, biotechnology, chemical engineering, or related field with 5 or more years of relevant experience, or

• Master’s degree with 3 or more years of relevant experience.

Experience:
Required:

• Demonstrated technical expertise in bioreactor operations and upstream bioprocessing.

Preferred:

• Proven experience leading manufacturing teams in a GMP environment.

• Proficiency with DeltaV and/or Unicorn control systems preferred.

• Experience supporting or owning deviations, CAPAs and change controls.

• Strong working knowledge of GMP documentation and regulatory expectations for clinical manufacturing.

Key Attributes:

• Recognized as a technical leader with strong analytical and troubleshooting skills.

• Demonstrated ability to lead teams and foster collaboration across functions.

• High degree of ownership, accountability, and professional integrity.

• Effective communicator capable of translating complex technical concepts to diverse audiences.

• Flexible and adaptable to dynamic clinical production environments including off-shift work as required.

Required Skills:

Adaptability, Adaptability, Analytical Testing, Biomanufacturing, Biotechnology, Chemical Biology, Chemical Engineering, Chemical Technology, Continuous Process Improvement, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Safety Compliance, Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing {+ 1 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:

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

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

$114,700.00 - $180,500.00

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

01/4/2026

*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:R377245