Job Description
I.GENERAL INFORMATION
Our company is expanding its global recombinant human papillomavirus (HPV) vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center 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's 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.
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II.GENERAL SUMMARY
The Operations organization is seeking to hire an experienced and technically proficient people manager to lead a team of coaches, production specialists, and operators through the capital project and commercial production readiness initiatives supporting the HPV vaccine franchise. This leader will collaborate with their colleagues in other Operations areas (i.e. Fermentation and Alum/Sterile Supply) and cross-functional teams (i.e. Maintenance, Global Engineering, Quality, and Technical Operations) to ensure a successful design, technology transfer, filing, licensure, and commercial production ramp up of the new HPV vaccine drug substance manufacturing facility.
This role will serve as one of the Associate Directors within the Operations organization that will:
- Support a comprehensive technology transfer of the HPV vaccine Purification area while ensuring compliance with all regulatory and safety guidelines.
- Lead a diverse team and be responsible for all human resource activities including one-on-one meetings, team development, hiring, talent assessment and performance reviews.
- Manage operational readiness project priorities, timelines, and resource allocation to achieve a successful project outcome while remaining within budget and on schedule.
PEOPLE MANAGEMENT
- Coaches/mentors direct reports responsible for their area within Operations.
- Responsible for establishing and maintaining a positive, diverse and inclusive working environment that allows all employees to achieve business objectives as well as personal goals.
- Assess capabilities and take action to maintain a high-performance learning organization.
FINANCIAL MANAGEMENT
- Supports responsive management 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.
PROJECT MANAGEMENT
- Responsible for supporting Global Engineering Services (GES) Capital Project Roadmap and Global Vaccine Technical Operations (GVTO) Tech Transfer execution including design, construction, installation, commissioning, validation, and process qualification activities.
- Responsible for leading Operational readiness and continuous improvement projects that will ensure Right First Time startup and ramp up of commercial manufacturing.
- Responsible for supporting all technology transfer activities as it relates to Purification
- Responsible for being an input into other facility and utility discussions as it relates to the Purification manufacturing areas.
- Responsible for working with relevant vendors and cross-functional team members to provide input and support of Factory Acceptance Testing (FAT) visits.
- Responsible for working with the Global Engineering and Validation teams to ensure the Sterile Supply and Adjuvant manufacturing areas are commissioned and qualified on time to meet project objectives.
- Responsible for leading a team that will participate in and support Quality Risk Assessments, Commissioning and Qualification activities, Engineering batches, PPQ batches, and license section authoring.
- Collaborate with internal/external partners, e.g. Other company sites, Procurement, Raw Material & Component Suppliers.
- Author, review, and/or edit operating procedures and training documents to support operator training qualification and production execution.
- Managing on-time implementation and close-out to meet project, production and supply timelines.
- Evaluate and develop innovative continuous improvements and post-launch process enhancements.
- Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
VII.QUALIFICATIONS
Required:
- Bachelor's Degree in Engineering, Science, or related field of study
- Minimum 6 years of experience in a regulated manufacturing industry
- Strong planning, scheduling, and time management skills
- Working knowledge of regulatory requirements in accordance with cGMP manufacturing operations
- Strong oral and written communication skills
- Proven track record of analytical skills, problem solving and attention to detail
- High personal integrity, credibility, and energy
- Strong team skills, including ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict
Preferred:
- Minimum of 5 years management experience
- Capital project management experience
- Risk Management experience
- Experience with tech transfer activities and supporting regulatory inspections
- Change Execution Management experience
- Lean Manufacturing experience
- Familiarity with validation and equipment qualification industry guidelines
- Experience leading sizeable (40+ FTE) multi-layer organization(s)
VIII.WORKING RELATIONSHIPS
- Reports to the Director of Operations
- Acts as the direct manager for their own Operations Suite team of 4-6 Managers, Production Specialists, and Lead Operators
- Frequent interaction with contract personal
- Interacts with representatives from regulatory agencies
- Interacts with external suppliers
Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
NOTICEFORINTERNALAPPLICANTS
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.
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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:
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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:
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:
10/13/2024
*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:R316248