Associate Director,Operations Job Durham area,North Carolina USA,Manufacturing / Production

Job Description

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.

The

duties of the Associate Director include but are not limited to:

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.

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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

Position

Qualification:

Required Education, Experience, and

Skills:

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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

Preferred

Experience and Skills:

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

Required Skills:

Aseptic Operations, Biopharmaceutical Industry, 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

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.

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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