Job Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC.  This state-of-the-art facility established in 2004, manufactures our Company lifesaving vaccines in bulk and finished forms.  Due to the importance of this facility in the 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. Our Company has an expansive vaccines portfolio and an exciting pipeline of human health vaccine candidates. This position will be part of a manufacturing organization that brings these vaccines to people around the world. 

Our ability to excel relies on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you.  To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

 

Position Description: 

We are seeking an Associate Director within the Durham Operations team. The Associate Director in Vaccine Manufacturing area is responsible for the oversight of Manufacturing Operations, at the Durham Vaccine Manufacturing Facility, while actively supporting, participating in and embracing an empowered team culture.

  

General Profile:  

Manages individual contributors (professional employees) and/or supervisors

Contributes to the performance and results of a department

Adapts plans and priorities based on departmental budget and profit plan to address resource and operational challenges

Decisions are guided by policies, procedures and business plan; receives guidance from manager

Provides technical guidance to employees, colleagues or clients

Anticipates and interprets client and/or customer needs to identify solutions

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 Business Expertise:  

Applies management skills to align staff activities with department objectives

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Functional Expertise: 

Specific to their area, the Associate Director will be responsible for comprehensive management of all activities required to successfully support and/or manufacture vaccine product to include the following: 

Lead the team and others by providing direction and guidance

Ensure compliance to Corporate, Site, and Departmental procedures associated with the manufacturing of vaccine product, and ensuring team is trained on new or revised processes or procedures

Review and approve Quality Notifications (QNs) 

Author, review, and approve SOPs

Take on project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Operations management

Determine staffing needs and hire to meet those demands

Serve as the Subject Matter Expert for all release related matters

Interact with Vendors and our Company Supplier Development and Procurement Management for issues associated with incoming components

Review and approve Vendor Change Notifications

Review and approve BOM changes

Review and approve Master Batch Records

Review and approve Operation, Technology, or Automation protocols

Participation in Kaizen events.

Direct support of regulatory inspections and audits.

Direct support of validation activities and all other associated Quality functions.

Other duties as requested by Management

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 Problem Solving:  

Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

Impact: 

Influence: 

Explains difficult concepts and persuades others to adopt a point of view.

Communicates information, asks questions and checks for understanding 

Accountability: 

Accountable for the performance and results of a unit 

Decision Making: 

Makes decisions – guided by policies and procedures – that impact the unit’s ability to meet performance objectives

Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes 

Strategic Planning: 

Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges 

 Resource Management:  

Forecasts resource needs; manages allocated budget 

 

Required Education, Experience and Skills:  

Bachelor's degree in Engineering, Science or related field AND at least eight (8) years working in a Manufacturing, Pharma, Biotech and / or Vaccines Industry in operations, planning, or functional support role(s) OR

Master’s degree in Engineering, Science or related field AND at least six (6) years working in a Manufacturing, Pharma, Biotech and / or Vaccines Industry in operations, planning, or functional support role(s)

Strong communication skills with the ability to present complex data sets to diverse audience with varying business acumen.

Demonstrated technical expertise during regulatory inspections and audits.

Demonstrated project management and analytical skills.

Proficient in Microsoft Office, including Excel and PowerPoint. 

Preferred Experience and Skills: 

Demonstrated experience leading teams (direct supervisor or project teams)

cGMP experience in a full-scale pharmaceutical vaccine manufacturing environment.

Experience in lean/six sigma and change management methodologies.

Experience with MRP/ERP systems such as SAP.

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.

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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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/1/2024

*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:10/01/2024

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:R314442