Job Description
GENERAL SUMMARY
The Associate Director – Fermentation Technology Lead within our Bulk Facility Technical Operations organization will be responsible for tactical and strategic decisions related to facility start-up and stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, regulatory compliance, employee and environmental safety, integration of new/existing technologies, customer service, resource utilization, financial performance and fiscal stewardship.
The role encompasses fermentation area support for technical/process issues, strategic projects, deviation management, change management, quality risk management, licensure and filing project management, and human resource activities for a technical staff.
GENERAL PROFILE
- Provides leadership and direction for a team of individual contributor full-time employees
- Adheres to site/project priorities based on departmental budget and profit plan to address resource and operational challenges
- Is part of the GBF Technical Operations Leadership Team along with partners from other suite teams
- Also interacts with other functional groups, including Operations, Quality, Automation, Maintenance and Safety
PEOPLE MANAGEMENT
- Coaches/mentors direct reports responsible for their area within Technical Operations
- Executes tasks related to people development such as one-on-ones, mid-year reviews, year-end review/calibration, team staff meetings, new employee onboarding, etc.
FINANCIAL MANAGEMENT
- Assists Technical Lead with managing the Technical cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year related to hiring and schedule adherence
TECHNICAL SUPPORT
- Responsible for execution of deviation management activities, including coaching staff through incident/investigation authoring, QN review/approval, speaking to QNs pulled for audits/inspections
- Responsible for oversight and project management of regulatory filing preparedness in the Fermentation area – including interactions with CMC-Reg, providing GBF source documents, escalating needs and issues related to license readiness
- Responsible for technology transfer and qualification of the fermentation process, including successful completion of engineering runs, PPQ stage gate review, successful PPQ execution, and maintaining alignment with the sending/partner sites in the network
- Collaborates with internal/external partners, e.g. Other of our Company sites, CMC-Reg, Procurement, Planning, Quality CoE, etc
- Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments
- Leads aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls
- Evaluates and develops innovative process technologies, continuous process improvements and post launch process enhancements
- Provides post approval support and subject matter expertise support to ongoing manufacturing activities.
- Develops a team of competent technical professionals through one-on-ones, midyear reviews, year-end reviews and continuous improvement efforts
Essential:
- Bachelor Degree in Engineering, Science or related field
- Minimum 7 years of experience in a GMP Facility or Capital Project as a technical staff member (5 Years with a Masters Degree, 3 years with a PhD)
- Previous people management experience required, including contractor management
- Strong planning, scheduling, and time management skills
- Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
- Good oral and written communication skills
- Experience with tech transfer activities and regulatory inspections
- Experience with deviation management and change control
- Project management, including change control, validation and equipment qualification
WORKING RELATIONSHIPS
- Reports to Director, GBF Technical Operations
- Manages and interacts with employees within own department
- Frequent interaction with employees from other departments
- Interacts with representatives from regulatory agencies
- Interacts with external suppliers
Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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