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Job: Associate Director, Operations, Merck & Co., Durham, NC

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General Information


Job title:
Associate Director, Operations
Job location:
Durham, NC  27701 United States
Requisition code:
R138632
Date posted:
09/11/2021
Compensation:
Job category:
Manufacturing and Production
Employment type:
Full time

Job Description


Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

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. 

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. Reporting to the Director of Operations, the Associate Director in the COVID-19 Drug Substance (CDS) area is responsible for the oversight and leadership of a department within the manufacturing operations, 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.

Business Expertise:

  • Applies management skills to align staff activities with department objectives.

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.

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.

Position Qualifications:

Education Minimum Requirement:

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

Required Experience and Skills:

  • 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.

Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time. 

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado

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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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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 Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

2

Requisition ID:R138632

Job Requirements


(see job description above)
(Job number: 4051047)
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