Sr Supervisor, QC Microbiology CAR-T
Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.Senior Supervisor, QC Microbiology CAR-TSummit, NJ
1. Purpose and Scope of Position
The Senior Supervisor, QC Microbiology supervises and oversees the activities and personnel in the microbiology group as they perform environmental monitoring and routine and non-routine microbiological testing in support of CAR-T manufacturing operations. Trends data, reviews documents, trains personnel, writes procedures, protocols/reports, performs investigations and identifies the appropriate CAPA's. The Senior Supervisor performs responsibilities independently in accordance with the Celgene's policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory guidelines/requirements at all times.
2. Required Competencies: Knowledge, Skills, and Abilities
· Ability to interact with regulatory agencies.
· Flexibility and ability to multi-task.
· Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory guidelines/requirements.
· Ability to interpret and write complex documents.
· Advanced written, verbal, and interpersonal communication skills.
· Advanced knowledge/experience with MS Word, Outlook, Excel, MS PowerPoint, Visio, LIMS.
· Advanced problem-solving skills.
· Strong organization and time management skills.
· Strong critical reasoning and decision-making skills.
· Strong teamwork and facilitation skills.
· Able to develop and motivate others; delegate and solve routine problems.
· Ability to gown and maintain an aseptic work environment.
3. Duties and Responsibilities
Ensure employees are properly trained and qualified.
- Assist with development and maintenance of the environmental monitoring program.
- Train and mentor lab personnel and other personnel from other departments as needed.
- Complete performance evaluations and support career development of direct reports.
- Assist with development of the gowning program, aseptic operator qualification program, and aseptic process validation program.
- Documents, tracks, and trends test results.
Performs review of cGMP documents.
- ·Serve as author and/or technical reviewer of departmental SOPs and other technical documents.
- Manage environmental monitoring trend reports.
- Prepare protocol, summary, document change and investigational reports as needed.
- Manage personnel work schedule to ensure all assigned tasks are performed in a timely manner.
- Utilize scientific principles to assist in troubleshooting and problem solving for deviations.
- Manage testing and environmental monitoring activities.
- Plans and develops special project work as needed.
- Manage microbial identifications.
- Initiates and performs Investigations/CAPA's associated with microbiological testing.
Act as liaison with other departments by representing QC Microbiology at cross functional team meetings.
- Effectively communicates with department and cross-functional management.
- Participate in cross-function meetings as needed.
- Perform other duties as assigned.
4. Education and Experience
- Bachelor's degree preferred, preferably in Microbiology or related science.
- 7-10 years' relevant work experience required, preferably in a Pharmaceutical manufacturing environment with cGMP requirements. Experience with cell therapy products is preferred.
- An equivalent combination of experience/education is acceptable.
5. Working Conditions
· This position may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting (NMT 25lb), or carrying (NMT 25lb).
· This may also include concentrating, remembering names, effective verbal and/or written communication, analytical thinking, decision making, and adapting to change.
· This position involves working conditions with constricted personnel movements for up to two (2) hours a day.
· This position works within controlled environments with defined gowning requirements.
· Will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.