Manager, Operations Nights

M1 Operations Manager

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

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

• Typically, coordinates and supervises the daily activities of individual contributors;

• 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 a 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 Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Support Talent Management.

• Direct, coordinate, provide guidance and counseling to group leaders to assure optimum quality and quantity of finished products.

• Keep all team members informed on current policies and procedures, and all other plant communications.

• Enforce all prescribed safety rules and regulations, and take prompt corrective action concerning potential safety hazards

• Provide leadership in establishing and maintaining a high efficiency and productivity level from the team members, while maintaining a focus on Safety First and Quality Always.

• Identify root causes of manufacturing issues and implement corrective action to minimize downtime with a focus on Safety, Quality, Delivery and Cost, in that order.

• Actively develop members to obtain maximum potential.

• Support and lead/participate in the Hoshin process and advocate for, and continually strive to achieve, our Vision

Education Minimum Requirement:

• High School Diploma AND at least Six (6) years in a manufacturing, technical, support, or Military role. OR

• Bachelor’s degree in a technical field AND at least Four (4) years in a manufacturing, technical, support, or Military role.

• Bachelor's degree and two (2) years of experience in a direct GMP, biotechnology, manufacturing setting.

Schedule:

• 2-2-3 schedule (2 days on , 2 days off, 3 days on) which includes every other weekend

• 12-hour night shift (7pm-7am)

Required Experience and Skills:

• Demonstrated ability to lead a team (i.e. experience leading directly as a supervisor/coach or indirectly as part of a project or through routine process execution).

• Ability to manage multiple priorities and coordinate people/resources to meet a production schedule.

• Strategic and effective interpersonal, communication, and problem-solving skills.

Preferred Experience and Skills:

• Demonstrated knowledge of MPS/Lean

• Drug Substance/Product start-up experience

• Demonstrated experience of interacting with site, divisional or regulatory audits

Core Skillsets

• Ability to develop and lead others

• Ability to be flexible and understand risk

• Continuous improvement

• Conflict resolution

• Leadership style – adaptive; high performance coaching; servant leader

Note: This job description is not intended to be all-inclusive. Employee may perform other related duties to support the organization.

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