Job Description

GENERAL SUMMARY:

Our company is expanding its global Bacillus Calmette Guerin (BCG)_vaccine production by adding an end-to-end manufacturing and laboratory building in a new facility located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for the BCG vaccine.

The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer activities to develop BCG and future testing capability at the Durham site. The successful candidate will report to the Associate Director, Laboratory Operations to lead start-up new laboratories for microbiological testing and environmental monitoring. Method transfer activities will include qualification of equipment, facility and utilities. Successful start-up of the laboratory will require candidates to work cross-functionally with existing Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using principles of our Production Systems, Lean Laboratories, and GMP requirements.

• Work cross-functionally with internal sites and global partners to build and operate testing capability within the Quality Laboratory Operations.
• Collaborate with internal customers and vendors to identify, to ensure successful execution of method transfer or method validation activities.
• Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgeting
• Build knowledge of the company, processes and internal/external customers
• Build and maintain strong relationships with site leadership, stakeholders, and customers
• Build relationships to work in a highly functioning diverse team environment
• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals
• Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing
• Capability to function effectively within an automated/electronic laboratory environment.

• Understands the fundamental business drivers for the company; uses this knowledge in own work
• Understands and applies regulatory/ compliance requirements relative to their role
• Influence, motivate, and energize individuals at all levels in the organization

• Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods
• Trouble-shoot laboratory process and equipment issues as needed
• Sample management
• Planning and test method execution to meet established delivery timelines
• Provide active support during audits and inspections (regulatory, internal, safety)
• Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
• Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements
• Influence, motivate, and energize individuals at all levels in the organization
• Support Divisional and Quality initiatives
• Additional project and routine testing support as required by laboratory testing requirements.
• Other duties as requested by management to support effective laboratory operations and performance metrics

• Identifies and solves a range of problems in both straightforward and undefined situations; analyzes possible solutions and assesses each using standard procedures

• Responds to standard requests from internal and external customers

• Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition
• Influence and Decision Making:
• Represents Quality in the laboratory to influence cGMP compliance and ensure product quality
• Explains information and persuades others in straightforward and low complexity situations as a subject matter expert
• Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines
• Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality

• Accountable for quality and/or technical contribution to project team or sub-team.
• Lead project team initiatives to ensure timelines are met and laboratories are prepared for routine product testing

• Aware of costs and assists in controlling costs related to own work

• B.S. or M.S. degree in Biological Sciences with a minimum of 5 years of laboratory experience.
• Experience with execution and troubleshooting of microbiological testing.
• Experience in Environmental Monitoring, including sampling, testing, and reporting.
• Experience with aseptic handling techniques.
• Technical writing skills.
• Previous GMP laboratory experience.

• Leadership experience.
• Experience in new assay development, validation, and/or technology transfer.
• Experience authoring technical documents supporting regulatory filings (FDA, EMA, JNDA).
• Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry.
• Experience in regulatory agency audits and/or regulatory filings.
• Experience with Lean Six-sigma and problem-solving tools.

• Ability to sit, stand and move within workspace for extended periods.
• Ability to work standing in a laboratory environment for extended periods.
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling.
• Ability to travel.

• Reports to Associate Director, Laboratory Operations.
• Represents the laboratory in cross functional project meetings.
• Interacts with employees within own department.
• Frequent interaction with employees from other departments and across sites.
• Interacts with representatives from regulatory agencies.
• Interacts with external suppliers.