Associate Director, Engineering

Job Description

Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products.  The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century.  Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. 

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 1,000+ 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, 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)

This role will serve as one of the Associate Directors within Technical Operations and will be responsible for the Thaw, Pool, and Filling operations within the VMF IPT.

• 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 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 sterile 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 Company's 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 compl