Associate Director, Operations
About the role
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 at a facility that includes end-to-end processing of drug substance and drug product, covering culture growth, harvest, filling, lyophilization, product inspection, utilities, warehouse, and quality control laboratories.
The role is accountable for building and leading the manufacturing team and strategy, providing communication across stakeholders to establish start-up and execute the manufacturing process.
Responsibilities
- Hiring, coaching, and developing a team of managers and technicians
- Ensuring execution to schedule and 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 subject-matter expert (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
- Adapting plans and priorities based on departmental budget and profit plan to address resource and operational challenges
- Ensuring compliance with corporate, site, and departmental procedures associated with the manufacturing of vaccine product, and ensuring team is trained on new or revised processes
- Identifying and resolving technical and operational problems; collaborating with peers to resolve cross-unit issues
- Other duties as requested by management
Requirements
Required Education, Experience, and Skills:
- 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 audiences with varying business acumen
- Demonstrated technical expertise during regulatory inspections and audits
- Demonstrated project management and analytical skills
Preferred Qualifications
- 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
Skills
Required Skills: Aseptic Operations, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Bioproducts, Capital Projects, Commercialization, 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
Pay
The salary range for this role is $129,000.00 - $203,100.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits
We offer a comprehensive package of benefits, including:
- Medical, dental, vision healthcare, and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Schedule
- Shift: 1st - Day
- Employee Status: Regular
- Relocation: Domestic
- VISA Sponsorship: No
- Travel Requirements: No travel required
- Flexible Work Arrangements: Not applicable