Associate Director, Operations

Job Description Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Our Company is expanding its global human papillomavirus (HPV) vaccine production for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine, comprised of sterile supply, fermentation, microfiltration/ultrafiltration, chromatography, and adjuvant production steps.-Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our Company manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally.- In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines. Position Description: The DS4 Production Operations organization is seeking to hire an experienced and technically proficient people manager to lead a team of coaches, production specialists, and operators through commercial production readiness initiatives supporting the HPV vaccine franchise expansion. This leader will collaborate with colleagues in other cross-functional teams to ensure a successful technology transfer, process performance qualification, filing, licensure, and commercial production ramp up of the new HPV vaccine drug substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will be accountable for the following:

• Support a comprehensive technology transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines.
  
• Lead a diverse team and be accountable for all human resource activities including one-on-one meetings, team development, hiring, talent assessment and performance reviews.
  
• Establish and maintain a positive, diverse and inclusive working environment that enables all employees to achieve business objectives as well as personal development goals.
  
• Assess team capabilities and execute strategies to maintain a high-performance learning organization
  
• Manage operational readiness project priorities, timelines, and resource allocation to achieve a successful project outcome while remaining within budget and on schedule.
  
• Manage of capital and expense spend by creating and revising financial forecasts throughout the year. Will manage operating cost center upon transition to commercial production utilizing zero-base philosophy.
  
• Evaluate and develop innovative continuous process improvements initiatives related to compliance, efficiency, and cost.
  
• Author, review, and/or edit operating procedures and training documents to support operator training qualification and production execution.
  
• Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
  

Working Relationships:

• Reports to the Director of Operations
  
• Facilitates Purification Suite leadership team, including cross-functional colleagues representing Quality, Engineering/Maintenance, Technical Operations, Validation, and Automation groups
  
• Direct interaction and collaboration with Production Operations Suite Leads
  
• Manages shop floor managers, leads, operators, and contract staff
  
• Interacts with representatives from regulatory agencies-
  
• Interacts with internal and external suppliers-
  
• Participates in Knowledge Management forums and best practice sharing with sister site peers
  

Position Qualifications: - Required Education, Experience and Skills:-

• Bachelor's Degree in Engineering, Science, or related field of study AND at least eight (8) years of experience in a regulated manufacturing industry OR
  
• Master's Degree AND at least six (6) years of experience in a regulated manufacturing industry OR
  
• A PhD AND at least four (4) years of experience in a regulated manufacturing industry
  
• At least two (2) years of management experience
  
• Working knowledge of regulatory requirements in accordance with current Good Manufacturing Practices (cGMP) manufacturing operations-
  
• Strong oral and written communication skills-
  
• Strong interpersonal skills, including ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict
  

- Preferred Experience and Skills:

• Downstream biomanufacturing process and equipment knowledge, including Homogenization, Microfiltration, Ultrafiltration, and Chromatography
  
• Working knowledge and capabilities in Production Systems and/or Lean Manufacturing
  
• High personal integrity, credibility, and energy
  
• Strong planning, scheduling, and time management skills-
  
• Experience in Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
  
• Capital project management experience
  
• Risk Management experience
  
• Experience supporting regulatory inspections-
  
• Change Execution Management / Strategy Realization Framework experience
  
• Experience leading multi-layer organization(s)
  

NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. 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. 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 EEOC GINA Supplement• Pay Transparency Nondiscrimination 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 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, generally Tuesday, Wednesday and either Monday or 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". 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:
Not Applicable Shift:
1st - Day Valid Driving License:
No Hazardous Material(s):
n/a Job Posting End Date:
06/7/2024
*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. Job Posting End Date: 06/07/2024 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: R295730