GENERAL SUMMARY:

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 company Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using principles of our company's Production Systems, Lean Laboratories, and GMP requirements.

GENERAL PROFILE:

• Work cross-functionally with internal company 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.

BUSINESS EXPERTISE:

• 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

FUNCTIONAL EXPERTISE:

The Laboratory Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation activities and routine product testing to include the following:

• 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 our Manufacturing 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

PROBLEM SOLVING:

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

INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:

• Responds to standard requests from internal and external customers

IMPACT:

• 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

PROJECT MANAGEMENT:

• 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

RESOURCE MANAGEMENT:

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

QUALIFICATIONS:

Required

• B.S. or M.S. degree in Sciences with a minimum of 5 years of laboratory experience

• Experience with execution and trouble-shooting of microbiological testing

• Experience in Environmental Monitoring, including sampling, testing, and reporting.

• Experience with aseptic handling techniques

• Technical writing skills

• Previous GMP laboratory experience

Preferred:

• 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

PHYSICAL REQUIREMENTS:

• 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

WORKING RELATIONSHIPS:

• 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 company sites

• Interacts with representatives from regulatory agencies