Education Minimum Requirement:

Bachelor's degree in science, engineering, or related discipline

Required Experience, Knowledge, and Skills:

Minimum of 8 years of experience in Pharmaceutical / Biotechnology industry role(s) with a BS, or 5+ years with an advanced degree Strong experience in Biologics Quality, Operations, and/or related functions at pilot and/or commercial scale. Demonstrated experience with quality risk management. Strong knowledge and application of Current Good Manufacturing Practice (cGMP). Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within an R D environment (i.e., apply the GMP Continuum). Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.

Preferred Experience and Skills:

Leadership of cross-functional teams and problem-solving situations. Strong knowledge of biologics processes, analytical, and regulatory requirements. Technical knowledge or proficiency in one or more elements of: GMP cleanroom facilities, electronic batch records, data integrity, SAP, automation, GMP operations in various product modalities or associated technologies. Advanced ability to identify and solve complex problems in a timely and efficient manner. Experience in facility start-up and GMP Operational Readiness or clinical supply areas and processes.

Required Skills:

Adaptability, Adaptability, Audit Management, Biopharmaceutical Industry, Compliance Investigations, Deviation Management, Global Program Development, GMP Compliance, Good Manufacturing Practices (GMP), Inspection Readiness, Manufacturing Support, Prioritization, Project Leadership, Project Risk Assessments, Quality Assurance Monitoring, Quality Assurance Systems, Quality Monitoring, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Regulatory Compliance, Regulatory Requirements, Risk Based Approach, Risk Management and Mitigation, Strategic Thinking {+ 2 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 $129,000.00 - $203,100.00 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:

No relocation

VISA Sponsorship:

No Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid Shift:

1st -

Day Valid Driving License:

No Hazardous Material(s):

No Job Posting End Date:

06/5/2026 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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