Associate Director, Operations

MSD•Durham, NC

2d•Onsite

About The Position

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always, Inclusion for All” 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. Position Description: We are seeking an Associate Director, Operations for a capital project start-up in Durham, North Carolina. The Associate Director will oversee a portion of the manufacturing team. The facility includes end-to-end processing of drug substance, drug product, including culture growth, harvest, filling, lyophilization, product inspection, utilities, warehouse, and quality control laboratories. The Associate Director is accountable for building and leading the manufacturing team and strategy, as well as providing communication across various stakeholders to establish start-up of and execute the manufacturing process.

Requirements

Bachelor's degree in Engineering, Science, or related field AND at least eight (8) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry OR A Master's Degree AND at least six (6) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry
Routine commercial manufacturing experience.
Direct and/or indirect leadership experience of teams and/or projects, including coaching and developing people
Strong communication skills with the ability to present complex data sets to diverse audience with varying business acumen.
Demonstrated technical expertise during regulatory inspections and audits.
Demonstrated project management and analytical skills
Aseptic Operations
Biopharmaceutical Industry
Biopharmaceuticals
Biopharmaceutics
Bioproducts
Capital Projects
Commercialization
Commercial Loan Restructuring
Decision Making
Global Manufacturing
GMP Compliance
Good Manufacturing Practices (GMP)
Lean Manufacturing
Manufacturing Operations
People Leadership
Pharmacology
Process Manufacturing
Production Scheduling
Regulatory Compliance
Strategic Thinking
Team Leadership

Nice To Haves

Experience with Good Manufacturing Practice (GMP) operations, tech transfer, capital projects, facility start-up, production, and improvement projects
Strategic, end-to-end thinking
Experience in regulated or GMP manufacturing and/or technical support of manufacturing operations
Experience with aseptic processing operations such as bulk production, formulation, vial filling, and lyophilization, and supporting clean utilities
Familiarity with change control systems and technical assessment of change in a current GMP production environment
Experience with sterile processing and sterility assurance practices and guidelines
Current Employees apply HERE
Current Contingent Workers apply HERE
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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
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Responsibilities

Hiring, coaching, and developing a team of managers and technicians
Ensure execution to schedule
Ownership for projects and improvement
Creating a strong safety culture
Contributing to the manufacturing team strategy for the facility
Directing routine process support and improvement activities
Serving as technical SME during regulatory inspections and audits.
Providing technical guidance for daily production, projects, deviations and changes.
Contributing to the facility leadership team, strategy, and guiding facility operations.
Adapts plans and priorities based on departmental budget and profit plan to address resource and operational challenges
Decisions are guided by policies, procedures and business plan; receives guidance from manager
Provides technical guidance to employees, colleagues or clients
Ensure compliance to Corporate, Site, and Departmental procedures associated with the manufacturing of vaccine product, and ensuring team is trained on new or revised processes or procedures
Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges
Other duties as requested by Management