DS4 Production Director - Durham

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.

GENERAL SUMMARY

A Director for the new Durham, NC HPV Bulk manufacturing facility production areas that manages new product design and assessment, tactical and strategic process, and human resource activities while ensuring 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.

GENERAL PROFILE

• Provides leadership and direction through managers and individual contributors (professional employees)
• Accountable for the performance and results of a department
• Executes functional business plans and contributes to the development of group or country strategies
• Priorities based on departmental budget and profit plan to address resource and operational challenges
• Decisions are guided by group or country strategies and policies
• Leverages relationships with key clients and/or customers to support business needs

PEOPLE MANAGEMENT

• Leads Production team for the new Durham, NC HPV Bulk manufacturing organization, including associate directors, coaches, technicians and engineers (150-160 people)
• Serves as a leadership team member for HPV Bulk
• Coaches/mentors direct reports responsible for each area within Production

FINANCIAL MANAGEMENT

• Responsible for the Production cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year

PROJECT MANAGEMENT

• Responsible for all production execution and associated systems

SHUTDOWN MANAGEMENT

• Coordinates with Engineering and Maintenance for all master shutdown schedules and shutdown execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdowns
• Attends daily shutdown meetings ensuring activities are tracked and completed

PRODUCTION SUPPORT

• Provides visible product and process quality leadership by incorporating into daily Business Unit operations, all known regulatory, cGMP, and internal company guidelines and policies applicable to process equipment and utilities. Reviews and approves investigations into process and equipment atypical events, impacting final disposition of product.
• Ensures compliance with all known federal and state laws, internal company guidelines and policies, and external customer Quality Assurance requirements. In conjunction with Quality Operations, provides responses to government agency requests. Provides input and recommendations for the development of site and divisional quality guidelines and policies.
• Provides visible safety leadership by incorporating into daily Business Unit operations, all known federal, state, and internal company safety guideline and policy requirements.
• Ensures compliance with all known federal and state environmental policies and laws as well as internal company environmental guidelines and policies. In conjunction with Environmental Services, provides responses to government agency requests.
• Manages Business Unit operations and resources to meet Production Planning and Control schedule, as well as other Operational Excellence program requirements. Develops strategic initiatives related to equipment and human resource strategies, in anticipation of Long Range Operating Plan requirements.
• In conjunction with associated support areas, develops organizational structure, exempt and hourly job descriptions, qualifications, and testing requirements. Actively participates in the hiring process by developing staffing plans, recruiting and interviewing for both internal and external hires. In conjunction with associated support functional areas, manages the development and implementation of technical and business training for exempt and hourly employees. Oversees through guidance, the development and mentoring of junior salaried employees. Develops Business Unit policies and philosophies with respect to the hourly workforce, including guidelines, work rules, and communication of values and principles.
• Manages effective internal and external Business Unit communications. Proactively seeks out and assists in clarifying the needs of other Business Unit members as well those of impacted external support areas.
• Manages manning and equipment utilization, maintenance and repair operating costs, product yields, and labor and material variances in order to reconcile monthly financial reports. Develops annual Businesses Unit Profit Plan and periodically forecasts Estimated Actual variances from the annual Plan, together with strategies for improved profitability. Ensures all Operational Excellence criteria are being complied with. Maintains appropriate Capital Project spending to plan.
• Provides input and recommendations for equipment and facility design, equipment and facility qualification, and process demonstrations and validations. Manages equipment and personnel to execute product and process trials, demonstrations, validations and clinical batches for Research Division and Manufacturing-Vaccine Technology & Engineering, in support of new products, line extensions and process improvements & worldwide company production strategies. Initiates research into manufacturing best practices both within and outside the vaccine manufacturing industry.

QUALIFICATIONS

Essential:

• Bachelor Degree in Engineering, Science or related field
• Minimum 10 years of experience in a production and/or calibration and/or maintenance background (8 Years with a Masters Degree or MBA : 5 years with a pHD)
• Minimum 2 years people management experience
• Strong planning, scheduling, and time management skills
• Working knowledge regulatory requirements in accordance with GMP manufacturing operations
• Good oral and written communication skills
• Experience with GMP compliant calibration and maintenance databases
• SAP experience related to plant maintenance and spare parts procurement systems
• Project management, including change control and equipment qualification

WORKING RELATIONSHIPS

Reports to Executive Director, Site Facility Lead

Manages and interacts with employees within own department

Frequent interaction with employees from other departments

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.

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

Who we are ...

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

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 world’s 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.

If you need an accommodation for the application process please email us at [email protected]
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement​
OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R27291