Associate Director, Engineering

Job Description

The Associate Director – Purification Technology Lead within the Vaccine Technical Operations organization will be responsible for tactical and strategic decisions related to tech transfer and process 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 purification area (Purification suites 4 and 5) 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 Facility 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 Director 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 Purification area – including interactions with CMC-Reg, providing source documents, escalating needs and issues related to license readiness

• Responsible for technology transfer and qualification of the purification process, including successful completion of engineering runs, clinical batches, successful process validation, and maintaining alignment with the sending/partner sites in the network

• Collaborates with internal/external partners, e.g. Other 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

QUALIFICATIONS

Essential:

• Bachelors Degree in Engineering, Science or related field

• Minimum 8 years of experience in a GMP Facility or Capital Project as a technical staff member

• 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

• Experience with tangential flow filtration and chromatography unit operations is preferred

WORKING RELATIONSHIPS

• Reports to Director, 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

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