Lead Technician, Operations

Durham Lead Technician, Operations

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing facility with a "Safety First, Quality Always" mindset, always 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.

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004 manufactures our Company's lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company's Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently the Durham site employs 1,000+ people.

The Durham site is supporting the expansion of our vaccine manufacturing to help eradicate HPV-related cancers and diseases. Members of the Operations team in this new and exciting facility will have the unique opportunity to experience licensure and ramp up to full production.

Durham's Lead Technician, Operations will be a leader with strong interpersonal, communication, and collaboration skills responsible for leading peers in supporting the manufacturing process. This individual will possess the ability to lead a team, train others and contribute to and implement process improvements.

This position will support the purification of the drug substance of our vaccine.

Responsibilities may include but are not limited to:

• Works in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for the production.
• Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and traceability of product.
• Maintains, inventories and transports all required equipment, materials, supplies and products.
• Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job aides, and learning documents.
• Performs general maintenance and assists or ability in troubleshooting of equipment independently.
• Performs housekeeping in all work areas. Executes facility decontamination according to procedures. Maintains, cleans and prepares equipment used in production.
• Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.
• Performs sampling/in-process testing supporting the manufacturing and validation process for current process as well as developmental work for new products/processes as required independently.
• Attends and actively participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
• Promotes a culture of visibility and accuracy of the manufacturing schedule and updates dashboards accordingly to highlight status to critical milestones.
• Actively participates on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.
• Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and SMEs.
• Analyzes and implements initiatives, training programs, and systems that will help to increase overall success within the department.
• Participates in training for new hire training programs.

Education Minimum Requirement:

• High School Diploma/GED or higher

Required Experience and Skills:

• Minimum four-year relevant work experience in GMP environment
• Demonstrated written and verbal communications skills
• Must be willing and able to lift 50 lbs and work on elevated platforms
• Must be willing to work 12.5 hour shifts (e.g. 6:00 PM – 6:30 AM)
• Must be willing to work a rotating 2-2-3 schedule (2 days on, 2 days off, 3 days on) which includes weekends

Preferred Experience and Skills (General):

• Demonstrated 2-4 years of leadership experience
• Minimum Associates Degree in science or related field
• Applicable mechanical and project management experience
• Proficiency with automated systems (MES, SAP, DeltaV)
• Experience training others and/or leading hands-on or instructor-led training
• Demonstrated knowledge of Lean Six Sigma/MPS principles
• Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements
• Demonstrated ability to work both independently and as a part of a team
• Strong collaboration, communication, and leadership skills
• Extensive Anion chromatography and large scale column packing experience
• Manufacturing Buffers (small and large scale) with pH and Conductivity adjustments
• Proficient with ultrafiltration / diafiltration (UFDF) using TFF skids
• Sterile filtration into final bulk
• Experience with CIP/SIP of tanks and associated piping