Associate Director, Operations

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 Inclusion for All 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 seeking an Associate Director Operations for a capital project start-up in Durham North Carolina. The Associate Director will oversee a portion of the manufacturing team. The facility includes end-to-end processing of drug substance drug product including culture growth harvest filling lyophilization product inspection utilities warehouse and quality control laboratories. The Associate Director is accountable for building and leading the manufacturing team and strategy as well as providing communication across various stakeholders to establish start-up of and execute the manufacturing process.

The duties of the Associate Director include but are not limited to:

• Hiring coaching and developing a team of managers and technicians

• Ensure execution to schedule

• Ownership for projects and improvement

• Creating a strong safety culture

• Contributing to the manufacturing team strategy for the facility

• Directing routine process support and improvement activities

• Serving as technical SME during regulatory inspections and audits.

• Providing technical guidance for daily production projects deviations and changes.

• Contributing to the facility leadership team strategy and guiding facility operations.

• 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

• 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

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

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

• Other duties as requested by Management

Position Qualification:

Required Education Experience and Skills:

• Bachelors degree in Engineering Science or related field AND at least eight (8) years of working in the Manufacturing Pharma Biotech and/or Vaccines industry OR

• A Masters Degree AND at least six (6) years of working in the Manufacturing Pharma Biotech and/or Vaccines industry

• Routine commercial manufacturing experience.

• Direct and/or indirect leadership experience of teams and/or projects including coaching and developing people

• 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

Preferred Experience and Skills:

• Experience with Good Manufacturing Practice (GMP) operations tech transfer capital projects facility start-up production and improvement projects

• Strategic end-to-end thinking

• Experience in regulated or GMP manufacturing and/or technical support of manufacturing operations

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

• Familiarity with change control systems and technical assessment of change in a current GMP production environment

• Experience with sterile processing and sterility assurance practices and guidelines

Required Skills:

Preferred Skills:

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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.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

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We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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