HPV Fermentation Mgr, Operations - Day Shift

Job Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. Due to the importance of this facility in our Company 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.

This role as a Manager, Operations will be an energetic, leader with strong interpersonal, leadership, and collaboration skills responsible for supporting Operational Readiness projects to support biological processes for a new manufacturing facility or currently established manufacturing facility. This role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will be required based on business unit needs during start up and operations, and specific assignments.

This position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities of: Media Preparation, Fermentation, Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning.

Accountability

• First line operations supervisor with a team of individual contributor production direct reports including safety, quality, and daily operations;

• Ensure that Shift(s) objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment and safety

• Tactical and strategic Shift(s) management, including collaboration with indirect staff;

• Promote the behaviors and principles that drive continuous improvement.

Duties

• Coordinates and supervises the daily activities of hourly personnel (Operations Technicians)

• Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors

• Decisions are guided by policies, procedures and business plan; receives guidance and oversight from Operations Associate Director and Director;

• Interprets client and/or customer needs and assesses requirements;

• Applies supervisory skills to improve efficiency and accomplish operational objectives within own unit;

• Identifies and resolves standard day-to-day technical and operational problems within own unit and collaborates with peers in other areas and functions;

• Sets priorities for unit to meet daily deadlines; develops plans to meet short-term objectives;

• Works within budgetary/ financial objectives set by Director;

• Makes decisions – guided by policies and standard operating procedures – that impact the efficiency and effectiveness of own unit;

• Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business.  Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement.  Responsible to review and approve compliance documents, as per procedures or need.

• Supply – Support Tier.  Exercise judgment and decision making to ensure quality product is reliably produced while managing cost.  Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.). 

• Continuous Improvement - Accountable for developing our Company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s).  Develop strategic initiatives related to the manufacturing process, equipment and human resources in support of long range operating plans.   Report Shift(s) monthly metrics and any action plans to address gaps to the Associate Director and/or Director.  Identify, prioritize, and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability, and eliminate waste.

• Financial Stewardship – Accountable for meeting the Shift(s) operating budget and continuously reducing cost.  Ensure members of the Shift(s) have business acumen and understand how they may impact business finances.

• People Management – Responsible for creating and sustaining a highly engaged workforce through utilization of our Company Leadership Behaviors and Inclusion.  Provide coaching on professional development and career paths.  Provide timely feedback and performance evaluations for direct reports after obtaining th