Job Description

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 Manufacturing Site in Durham, NC is hiring Operations Managers across multiple products and processes. The hiring team will determine based on your experience and skill set where you would make the greatest positive impact as an Operations Manager. These positions are night shift roles, typically with a 12 hour (6 pm to 6 am), rotating (2-2-3) schedule.

The role of Operations Manager at our Durham facility is a manufacturing first level management role. The Operations Manager will provide direction, coaching, and technical expertise to operations personnel who are accountable for the manufacturing processes. They will also actively manage their assigned team to reliably support customer demand. This may include hiring as needed, employee development, coaching, and performance management.

Additionally, this role provides the opportunity to become proficient in the use of manufacturing systems and build knowledge of site procedures in order to resolve process/equipment issues, minimize downtime, and ensure product quality.

The Operations Manager leads the manufacturing process with a team assigned to cell culture, fermentation, bacterial propagation, purification, filling, lyophilization, crimping/sealing, product inspection, media preparation and/or sterile assembly, as well as other production-related activities. Typical shifts is 12 hour rotating night shifts (6 pm to 6 am, 2-2-3 rotation).

Primary Responsibilities
Employee Development | People Management

* Develop, motivate, and manage a team to ensure reliable manufacturing process execution

* Assign yearly performance objectives for the team in alignment with department and site goals

* Provide regular feedback and coaching to employees on work performance

* Provide leadership to the team as needed based on the teams capabilities and maturity

* Build team culture and mediate conflict as needed

Process Execution | Continuous Improvement

* Provide a leadership presence on the manufacturing floor

* Champion standard work to drive consistent use of best practices across teams

* Assist the team in troubleshooting issues to minimize downtime and maintain product quality

* Identify opportunities to improve the process (e.g. cycle times, ease of execution, reliability)

* Support work as needed to implement improvements (e.g. scheduling, staffing, protocol execution)

* Coach team members in executing smaller improvement projects in their operational area

* Represent Operations on project teams as needed

* Support operations production through start-up and commissioning and qualification through licensure and ramp up

* Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job aides, and learning documents

* Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones

Communication

* Lead and support daily (Tier) meetings to facilitate flow of information up/down through the organization

* Hold regular team meetings to cascade information and collect team feedback

* Provide clear consistent communication from shift to shift

* Escalate issues as needed to ensure the right support/awareness is given to issues as they arise

* Serve as a Subject Matter Expert (SME) during tours to provide area/process overview information to visitors/auditors upon request

Quality & Safety Compliance

* Foster strong safety culture on the team through actions, coaching, and prioritization

* Coach individuals when reporting safety issues and completing corrective/preventative actions

* Drive culture of compliance through actions, consistent quality-driven decision making, and coaching of the team (e.g. documentation, housekeeping, area 5S, etc.)

* Participate in safety/regulatory audits (i.e. tours, topic discussion)

Financial

* Coach the team to ensure SAP transaction completion is timely and accurate

* Manage team staffing and overtime to support customer demand while meeting budget targets

* Recognize opportunities for cost savings and communicates them for potential project chartering

Education Minimum Requirements

* High School Diploma AND at least Six (6) years in a manufacturing, technical, support, or Military role OR

* Bachelors degree in a technical field AND at least Four (4) years in a manufacturing, technical, support, or Military role

Required Experience and Skills

* Willingness to work a flexible schedule covering various shifts

* Demonstrated ability to lead a team (i.e. experience leading directly as a supervisor/coach or indirectly as part of a project or through routine process execution)

* Ability to manage multiple priorities and coordinate people/resources to meet a production schedule

* Strategic and effective interpersonal, communication, and problem-solving skills

Preferred Experience and Skills

* Previous supervisor role

* Working knowledge of Good Manufacturing Practices (GMP)

* Electronic manufacturing systems (e.g. PAS-X, SAP, Delta-V, GLIMS etc.)

* Interacting with regulatory auditors as part of area tours and/or topic discussion

* Certified Yellow Belt/Green Belt/Black Belt

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 thats 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

VetM1

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

EEOC GINA Supplement

OFCCP EEO Supplement

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 anothers 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:

Shift:

3rd - Night

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

8
Requisition ID:R95765