**Job Description** Seeking candidates for a leadership position in our company's Biologics Pilot Plant Process Operations Team. This individual will provide technical leadership to campaign teams focusing on downstream unit operations in Good Manufacturing Practice manufacture of bulk biologics, vaccines, and adjuvant clinical supplies. Candidate is expected work in a team atmosphere in close collaboration with the development and operations groups. Primary responsibility includes technical guidance during preparation, execution, and closeout of a Good Manufacturing Practice campaign. Candidate will participate in/oversee a range of specific activities including, but are not limited to, equipment specification, equipment start-up, campaign document preparation/review, process fit within the Biologics Pilot Plant Process suites, planning/execution/close-out of Good Manufacturing Practice batches, and mentorship/guidance of staff. The candidate will also need to collaborate across the development program teams with the ability to influence functional leadership to drive program decisions. A key element of this assignment is coordinating the campaign activities with the process development functions, various groups within the Biologics Pilot Plant operations, Good Manufacturing Practice /safety, raw material planning), Quality, and other supporting functional areas. Strong technical and project management skills will be necessary to manage timelines to support the pipeline portfolio. Individual is expected to technically guide staff focusing on multiple campaigns at a time while building cross-functional relationships. In addition to the core responsibilities above, an opportunity exists to streamline various business processes for efficiently preparing for clinical supplies for products in all phases of development in this multi-product facility. Individual should have ability to steer decisions for downstream unit operations fit with line of site to program lifecycle management. **Education Minimum Requirement:** + BS degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry. **Required Experience and Skills:** + Demonstrated ability to mentor individuals and influence functional groups. + Strong technical knowledge of large molecule purification processes with subject matter expertise in at least one. + Technical and operational knowledge of large molecule manufacturing, including knowledge of cGMP, Quality Systems, and Safety for operations. + The incumbent should be highly motivated with the ability to work in a fast-paced and dynamic setting + Strong technical knowledge of changes that must be considered moving from process development to clinical manufacturing with line of site to commercial readiness with ability to influence adaptation of change. **Preferred** **Experience and Skills:** + Strong technical background in several bio-process unit operations + Experience with technology transfer of large molecule programs + Previous experience leading technical projects + Excellent organizational and problem-solving skills + Proven leadership and project management skills + Demonstrates the ability to work both independently and in team environments delivering strong results + Demonstrates exceptional conflict management and negotiation skills + Ability to help to create and define compelling vision, drive change, influence decision making + Effective communication skills and personnel development aptitude is preferred + Demonstration of Decision Making, Execution Excellence, Innovation, and Change Catalyst Leadership Skills Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 (https://www.msdprivacy.com/us/en/CCPA-notice/) **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”. **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:** No Travel Required **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** Yes **Job Posting End Date:** 02/15/2025 ***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:** R332520