Senior Specialist, Operations

MSD•Durham, NC

1d•$106,200 - $167,200•Onsite

About The Position

The Manufacturing Operations Senior Specialist role within our company is a manufacturing leadership role supporting a vaccine end to end manufacturing process (e.g. media preparation, harvesting, filling, lyophilization, capping and inspection, and packaging), testing and release. You must provide direction, coaching, and technical expertise to operations support personnel responsible for running/improving the manufacturing, testing and release processes and business systems. This individual must actively manage their assigned team to reliably support commercial operations (including hiring, employee development, routine 1:1 meetings and coaching, recognition, and performance management). Additionally, they must become proficient in the use of manufacturing systems and knowledgeable of site procedures to lead their team through resolving/improving manufacturing and business processes.

Requirements

Medical clearance
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)
Lean Six Sigma certification
Demonstrated mastery of Company Production Systems, problem solving, process improvements, LEAN manufacturing practices
Strong leadership and interpersonal skills, technical aptitude with the ability to learn new skills and tasks, and problem-solving skills; strong team skills and interpersonal skills including motivating/empowering others and resolving conflict
Ability to manage multiple priorities and coordinate people/resources to meet a production schedule
Strong interpersonal, communication, and problem-solving skills

Nice To Haves

Previous supervisory experience
Experience in a Good Manufacturing Practice (GMP)-regulated manufacturing environment using electronic manufacturing systems (e.g. SAP, GLIMs, etc.)
Experience interacting with regulatory auditors as part of area tours and/or topic discussion

Responsibilities

Develop, motivate, and manage a team to ensure reliable manufacturing, testing and release execution
Assign yearly performance objectives for the team in alignment with department and site goals
Provide regular feedback and coaching to employees on work performance
Provide leadership to the team as needed based on the team’s capabilities and maturity
Provide a leadership presence on the manufacturing floor
Champion standard work to drive consistent use of best practices across teams
Regularly help the team troubleshoot issues to minimize downtime and maintain product quality
Identify opportunities to improve the process (e.g. cycle times, ease of execution, reliability)
Support work as needed to implement improvements (e.g. scheduling, staffing, protocol execution)
Coach team members in executing smaller improvement projects in their operational area
Represent Operations on project teams
Lead and support site (Tier) meetings to facilitate flow of information up/down through the organization
Hold regular team meetings to cascade information and collect team feedback
Provide clear consistent communication to site stakeholders
Escalate issues as needed to ensure the right support/awareness is given to issues as they arise
Serve as a Subject Matter Expert (SME) during tours to provide area/process overview information to visitors/auditors upon request
Foster strong safety culture on the team through actions, coaching, and prioritization
Coach individuals when reporting safety issues and completing corrective/preventative actions
Drive culture of compliance through actions, consistent quality-driven decision making, and coaching of the team (e.g. documentation, housekeeping, area 5S, etc.)
Participate in safety/regulatory audits (i.e. tours, topic discussion)
Manages the Site cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year
Recognize opportunities for cost savings and communicates them for potential project chartering