Associate Director, Rightsource Operations

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

**Job Summary**:
Responsible for implementing a new cGMP Testing facility in Stevenage, UK for our RightSource group. This testing site will be used for quick turn-around-time assays to support C&GT clients in the vicinity. The focus of the assays will be around Microbiology and product specific release assays. This role requires someone who is comfortable setting up a lab from scratch with support from global operations. Includes responsibility for technical oversight and operational performance of Biologics Testing Services performed in the United Kingdom, primarily at the new site in Stevenage, UK. Primary liaison for assigned key client(s) within the UK to establish and foster best practice initiatives, provide technical and operational consultation, enhance communication, and facilitate positive client relationships.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**:

- Establish and run a new biologics testing cGMP facility in the UK.
- Liaise with global operations, procurement, QA, HR, IT, and other functions in establishing the lab.
- Provide technical guidance to staff, scientists and clients as needed.
- Day to day oversight to ensure on-time delivery of all client projects related to biologics testing services.
- Work within and external to the group to resolve scientific and technical issues.
- Oversee acquisition and implementation of new technologies.
- Ensure compliance with all applicable local, state, and federal regulations, including but not limited to GMP, FDA, and OSHA.
- Supervise staff and provide excellent service to customers.
- Responsible for refinement and development of assays as needed to meet current industry standards and the subsequent training of technical personnel in general laboratory skills; reinforce regulatory concepts (cGMP) and specific laboratory techniques.
- Provide guidance to Customer Service and Sales departments in drafting proposals, reviewing proposals and handling customer relations.
- Maintain assays in a state of current industry standard validation, including revalidation when necessary to meet regulatory expectations.
- Document revisions to ensure the laboratory maintains its compliance status.
- Participate in industry technical and trade groups to enhance the company's image as an industry leader, generate new business leads and strengthen market intelligence.
- Interact closely with other Site department heads and Charles River personnel to ensure seamless Biologics Testing Solutions operations and client satisfaction.
- Direct activities of assigned group(s) to ensure optimum performance of the group/function.
- Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
- Develop short
- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
- Integrate activities with those of other major organizational units (e.g., segments, departments, functions).
- Develop and recommend departmental budget and authorize expenditures.
- Collaborate with site training to implement departmental training programs, including orientation.
- Support the policy of equal employment opportunity through affirmative action in personnel actions.
- Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
- Perform all other related duties as assigned.

**Job Qualifications**:
**With respect to all assays and tests performed in laboratories managed, the Associate Director of RightSource UK assures that**:

- Study or assay protocols, including any changes, are approved as provided by applicable regulatory requirements and that the protocols are followed.
- All experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
- Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
- Test systems, including reagents, live cells, equipment, or other material are as specified in the protocol.
- All applicable good laboratory or manufacturing practice regulations are followed, as applicable.
- All raw data, documentation, protocols, specimens, and final reports ar