Associate Director, Vaccine Manufacturing Facility (VMF) Technical Operations

Job Description

Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham NC. The facility established in 2004 manufactures our lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Vaccine Manufacturing network the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1000 people.

Vaccines Science & Technology (S&T) in our Manufacturing Division is seeking a highly motivated individual for the role of Associate Director within the Vaccine Manufacturing Facility (VMF) Technology organization. The Technical Operations Associate Director will collaborate cross-functionally within the Integrated Process Team (IPT) to provide technical support to the manufacturing shop floor within the vaccine fill-finish facility. This role involves leading multiple individual contributors driving change management for continuous improvement projects supporting complex investigations and demonstrating deep subject matter expertise during proactive problem solving and troubleshooting. The Associate Director will be a key contributor to meeting our key strategic priorities associated with safety compliance delivery cost and people.

Responsibilities (may include but not limited to)

• Provide leadership and direction for a team of highly technical individual contributors and be responsible for all human resource activities including one-on-one meetings team development hiring talent assessment and performance reviews.

• Coordinate responses to process upsets including short-term mitigation to return to service and assessment of product impact

• Prioritize projects timelines and resource allocation to improve safety compliance stability cost and capacity

• Approve investigations SOPs change requests protocols CAPAs Quality Risk Assessments

• Support of regulatory audits with coaching Subject Matter Experts (SMEs) and presenting to auditors

• Collaborates with internal/external partners e.g. other of our companys sites CMC-Regulatory Procurement Supply Chain / Planning Quality Center of Excellence (CoE) etc.

Qualifications

Education Minimum Requirement:

• B.S. Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 8 years in biological and/or vaccines industries; OR

• M.S. Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 6 years in biological and/or vaccines industries; OR

• PhD Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 3 years in biological and/or vaccines industries

Required Experience and Skills:

• Recognized technical expert with experience in vaccine or biologics manufacturing within a cGMP environment

• Demonstrated ability to develop innovative solutions for complex problems and business processes or systems

• Demonstrated experience in solving major investigations within cGMP manufacturing

• Demonstrated effective written and verbal communication skills with ability to influence peers

• Ability to build strong collaborative relationships with internal partners and sites as well as with external partners

Preferred Experience and Skills:

• People management and/or mentoring experience

• Demonstrated experience in vaccines or biologics drug product commercial manufacturing unit operations such as bulk formulation vial filling lyophilization sealing and container inspection

• Familiarity with risk management and/or our companys Production Systems (MPS) methodologies

• Experience with deviation management change control project management and/or process validation

• Strong capability in applying scientific and engineering principles for problem solving and implementation of solutions

• Expertise in exploring complex manufacturing data to identify opportunities for improvement

• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations

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The salary range for this role is

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.

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