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.

Position Description:

We are currently seeking a Director, Operations to lead production for a new capital project start-up facility in Durham, North Carolina. The facility will include end-to-end (E2E) processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and quality control laboratories. The Operations team will manage manufacturing facility production areas that partner in facility design and assessment, tactical and strategic processes, and human resource activities during construction, commissioning and qualification, through to running operations of the facility. The Director will be responsible for optimized product quality and manufacturing processes, regulatory compliance, employee and environmental safety, integration of new/existing technologies, customer service, resource utilization, financial performance and fiscal stewardship.

This role reports to the Executive Director, Facility Lead and is a member of the facility leadership team.

The responsibilities of the Director, Operations include but are not limited to:

* Influencing and directing through associate directors, managers, and individual contributors

* Accountability for safety first, quality always in the team and building culture accordingly

* Accountability for the performance and results the full production department

* Executing functional business plans and contributes to the development of facility strategies

* Establishing priorities based on departmental budget and profit plan to address resource and operational challenges

* Leveraging relationships with key clients and/or customers to support business needs

* Managing a Production team for the new facility, including Associate Directors, Managers, Technicians and Engineers (60-90 people)

* Serving on facility leadership team including ownership of strategy for production team

* Coaching and mentoring direct reports responsible for each area within Production including drug substance, drug product, lyophilization, product inspection

* Managing the Production cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year

* Leading production team representation during internal audits and regulatory agency inspections

* Coordinating with Plant Engineering and Maintenance for shutdown execution

Position Qualification:

Required Education, Experience and Skills:

* Bachelors degree AND at least ten (10) years of experience in more than one functional area such as Manufacturing Operations, Quality Operations, Technical Operations, Supply Chain or Engineering OR

* Master's degree AND at least eight (8) years of experience in more than one functional area such as Manufacturing Operations, Quality Operations, Technical Operations, Supply Chain or Engineering OR

* PhD AND at least five (5) years of experience in more than one functional area such as Manufacturing Operations, Quality Operations, Technical Operations, Supply Chain or Engineering

* A Degree in Engineering, Science or related field

* Experience in biotech, vaccine, or pharmaceutical GMP environment

* At least two (2) years of people management

Preferred experience and skills:

* Experience with tech transfer, capital projects, facility start-up, production support, and improvement projects

* Experience with direct leadership experience of teams and/or projects, including coaching and developing people

* Strategic, end-to-end thinking

* Experience with Operational Excellence, Lean, Six Sigma programs

* Experience with regulatory agencies and inspections

* Strong written and oral communication skills

* Experience with aseptic processing operations such as bulk production, formulation, vial filling, and lyophilization, and supporting clean utilities

* Experience with setting a culture, establishing a new team, and team building

Our Manufacturing & Supply Division is dedicated to being 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.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the worlds biggest investors in Research & Development.

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.

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:

Not Specified

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R78233