Msd
Manager, Process Operations
USA - New Jersey - Rahway · Contract
Sponsorship not specified$117k-$184kDetected 1 day ago
Data AnalysisProject ManagementProcess ImprovementHRISCustomer SupportGMPResearchLeadershipCommunicationMicrosoft OfficeLean Manufacturing
About the role
- This facility will be fully online in the next few years, both in terms of facility construction and organizational realization.
- Please click here if you need an accommodation during the application or hiring process.
- The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
Responsibilities
- Lead a team executing upstream and downstream production operations.
- Drive cGMP and EHS compliance and promote a strong safety culture.
- Maintain a strong floor presence during GMP operations and support critical tasks as needed.
- Support operational readiness activities for launch of the new GMP facility.
- Coach and develop direct reports through regular 1:1s, feedback, and performance reviews.
- Drive Right First Time (RFT) batch execution and operational excellence.
- Review documentation in real time to support timely lot release.
- Initiate deviations, perform initial impact assessments, and support investigations.
Nice to have
- Preferred Experience and Skills:
- Preferred Skills:
Skills
- Minimum 5 years of experience in a GMP-regulated biologics drug substance manufacturing environment, preferably with single-use systems.
- Prior experience leading operations teams and monitoring performance.
- Strong understanding of GMP manufacturing environments, including upstream and downstream processing.
- Working knowledge of cGMP, Quality Systems, and EHS requirements.
- Ability to train employees in technical, compliance, safety, and environmental procedures.
- Experience writing SOPs and technical documents.
- Working knowledge of DeltaV, MES, and SAP.
- Strong troubleshooting, decision-making, and attention to detail skills.
- Demonstrated initiative and ability to work effectively in a fast-paced environment.
- Experience with facility fit assessments, new product introduction, process transfer to/from clinical sites, and clinical manufacturing.
- Experience with Veeva Quality Docs.
- Lean manufacturing and root cause analysis experience.
Compensation
- The salary range for this role is
Benefits
- Provide off-hours, weekend, holiday, and on-call support as needed.
Company info
- 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.
- 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.
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.
Visa & Work Authorization
- VISA Sponsorship:
This listing is sourced directly from Msd's careers page and normalized into a canonical job model.