About the position
The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures lifesaving vaccines in bulk and finished forms. The Durham site is supporting the expansion of a new vaccine manufacturing facility to help eradicate HPV-related cancers. Members of the Operations team in this new and exciting facility will have the unique opportunity to experience commercialization which includes facility start up, licensure, and ramp up to full production. As a Senior Specialist, Operations you will be in a critical position to the organization with direct impact on our Company vision to make a difference in the lives of people globally. In this role you will be a project manager that drives the execution of production objectives, while creating an inclusive culture that energizes a Safety First, Quality Always, continuous improvement mindset. You will also have the ability to direct, coordinate, and counsel cross-functional collaboration with Quality, Technical Services, Planning, Global Functions and other areas to assure optimal quality and quantity of finished products. This is an excellent opportunity if you are looking to build or expand your career in Vaccine Manufacturing. As a Senior Specialist you will be given the opportunity to challenge and grow your talents through progressive on the job training and development of interpersonal and leadership skills to overcome business complexities and solve technical problems.
Responsibilities
- Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.
- Drive transparency, inspection, and adaptation of project plan progress-ensuring tactical execution plans align with operational strategy.
- Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones.
- Management of project schedule, project portfolio, and project Tier processes.
- Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency.
- Lead scenario planning, risk assessments, and prioritization of critical activities.
- Create schedule adherence metrics and identify opportunities for continuous improvement.
- Actively manage appropriate cross-functional involvement in activities and decision-making.
- Author, review, and/or edit procedures and technical documents to support Operations and regulatory filings.
- Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
- Attends and actively participates in facility gembas, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
- Analyzing and implementing initiatives, training programs, and systems that will help to increase overall success within the department.
Requirements
- Bachelor's (BA/BS) degree in Engineering, Business, Biological Science/Biotechnology, or a related field.
- Minimum of 5 years of commercial manufacturing experience within the biopharmaceutical, pharmaceutical, biotechnology, or life sciences industries (or 3 years of experience with a master's degree in a related field).
- Proactive self-starter with strong leadership skills, executive presence, and cross-functional influencing abilities.
- Demonstrated proficiency in project management and execution of plans across a broad group of stakeholders/functions.
Nice-to-haves
- Exceptional written and verbal communication and presentation skills.
- Documented success in developing strategies and executing tactical plans with cross-functional teams.
- Demonstrated ability to manage multiple initiatives simultaneously.
- Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools.
- Excellent planning, organizational, documentation and communication skills to ensure alignment of customers' needs relative to site output.
- Capable of managing and re-evaluating the production plan under very dynamic circumstances.
- Experience in SAP, automation and manufacturing execution system (MES), process modeling and process improvement.
- Experience in a manufacturing facility start up and commercialization and cGMP manufacturing and familiarity with regulatory requirements.
Benefits
- 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.
