Durham, NC, 27722, USA
2 days ago
Associate Director, Vaccine Manufacturing Facility (VMF) Technical Operations
**Job Description** **Description** The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. The facility established in 2004, manufactures our lifesaving vaccines in bulk and finished forms.  Due to the importance of this facility in our Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.  Vaccines Science & Technology (S&T) in our Manufacturing Division is seeking a highly motivated individual for the role of Associate Director within the Vaccine Manufacturing Facility (VMF) Technology organization. The Technical Operations Associate Director will collaborate cross-functionally within the Integrated Process Team (IPT) to provide technical support to the manufacturing shop floor within the vaccine fill-finish facility. This role involves leading multiple individual contributors, driving change management for continuous improvement projects, supporting complex investigations, and demonstrating deep subject matter expertise during proactive problem solving and troubleshooting. The Associate Director will be a key contributor to meeting our key strategic priorities associated with safety, compliance, delivery, cost, and people. **Responsibilities (may include, but not limited to)** + Provide leadership and direction for a team of highly technical individual contributors and be responsible for all human resource activities including one-on-one meetings, team development, hiring, talent assessment and performance reviews. + Coordinate responses to process upsets, including short-term mitigation to return to service and assessment of product impact + Prioritize projects, timelines, and resource allocation to improve safety, compliance, stability, cost and capacity + Approve investigations, SOPs, change requests, protocols, CAPAs, Quality Risk Assessments + Support of regulatory audits with coaching Subject Matter Experts (SMEs) and presenting to auditors + Collaborates with internal/external partners, e.g. other of our company's sites, CMC-Regulatory, Procurement, Supply Chain / Planning, Quality Center of Excellence (CoE), etc. **Qualifications** Education Minimum Requirement: + B.S. Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 8 years in biological and/or vaccines industries; OR + M.S. Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 6 years in biological and/or vaccines industries; OR + PhD Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 3 years in biological and/or vaccines industries Required Experience and Skills: + Recognized technical expert with experience in vaccine or biologics manufacturing within a cGMP environment + Demonstrated ability to develop innovative solutions for complex problems and business processes or systems + Demonstrated experience in solving major investigations within cGMP manufacturing + Demonstrated effective written and verbal communication skills with ability to influence peers + Ability to build strong collaborative relationships with internal partners and sites as well as with external partners Preferred Experience and Skills: + People management and/or mentoring experience + Demonstrated experience in vaccines or biologics drug product commercial manufacturing unit operations such as bulk formulation, vial filling, lyophilization, sealing, and container inspection + Familiarity with risk management and/or our company's Production Systems (MPS) methodologies + Experience with deviation management, change control, project management, and/or process validation + Strong capability in applying scientific and engineering principles for problem solving and implementation of solutions + Expertise in exploring complex manufacturing data to identify opportunities for improvement + Working knowledge of regulatory requirements in accordance with GMP manufacturing operations 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. 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) 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 (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”. The salary range for this role is $139,600.00 - $219,700.00 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:** Domestic **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Required Skills:** API Manufacturing, API Manufacturing, Biological Manufacturing, Biopharmaceutical Industry, Business Processes, Business Systems, Change Control Systems, Chemical Engineering, Chemical Process Development, Cross-Cultural Awareness, Cross-Functional Teamwork, Engineering Principle, Equipment Qualification, GMP Compliance, Leadership, Manufacturing Operations, Manufacturing Process Validation, People Leadership, Problem Solving, Process Optimization, Project Management, Regulatory Inspections, Regulatory Requirements, Results-Oriented, Strategic Thinking {+ 2 more} **Preferred Skills:** **Job Posting End Date:** 07/2/2025 ***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:** R353873
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