Supervisor, Manufacturing, CAR-T
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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.
Purpose and Scope of Position:
Supervises the employees who manufacture human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cleanroom environment. Manufacturing Supervisors address employee concerns, ensures staff are complaint with training requirements, reviews & approves timecards, and addresses production issues with cross functional teams. Communication of production deviations and assistance with quality investigations are required, as applicable.
Required Competencies: Knowledge/ Skills, and Abilities:
Advanced understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
Knowledge of cGMP/FDA regulated industry
Basic mathematical skills
Technical writing capability
Proficient in MS Office applications
Background to include an understanding of biology, chemistry, medical or clinical practices
Previous experience managing, coaching, and providing instructions to staff
Sufficient vision and hearing capability to work in job environment.
Duties and Responsibilities:
Ensures staff are properly trained on controlled, approved GMP procedures.
Manages individual development plans for direct reports.
Documents employee growth and performance.
Reviews and approves employee timecards.
Conducts annual employee performance review with direct reports.
Documents and addresses employee corrective actions and performance improvement plans.
Trained in all areas of manufacturing staff upon completion of all proficient tasks.
Pre- and Post-Production shift communication to manufacturing team.
Manages on the floor production issues cross functionally.
Escalates concerns/ issues to Manufacturing Management.
Hires and interviews new employees.
Other duties may be assigned, as necessary.
Requirements:
Required Education and Experience:
Master’s degree plus 4 years of experience
OR Bachelor’s degree plus 6 years of experience
OR Associate/ Medical Technical degree and 7 years of Manufacturing or Operations experience
OR High School diploma/GED and 8 years of Manufacturing or Operations experience.
Working Conditions:
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Physical dexterity sufficient to use computers and documentation.
Ability to lift up to 25 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
Flexibility to don clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
Routine exposure to human blood components.
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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.
