Celgene

Supervisor, Cell Therapy Manufacturing Operations

Posted on: 11 Apr 2021

Summit, NJ

Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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.

This position is for Quad 3, Thurs-Saturday, every other Wednesday 6 am-6 pm. Start and end times are subject to change based on business demands.

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.

Required Competencies:

Education and Experience:

* Masters degree plus 4 years of experience
* OR Bachelors 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.

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

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.
* Sufficient vision and hearing capability to work in job environment.
* 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.
* Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.

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.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Celgene

Summit, NJ

Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases worldwide. It offers REVLIMID, an oral immunomodulatory drug for multiple myeloma (MM), myelodysplastic syndromes (MDS), and mantle cell lymphoma; POMALYST/IMNOVID to treat multiple myeloma; OTEZLA, a small-molecule inhibitor of phosphodiesterase 4 for psoriatic arthritis and psoriasis; and ABRAXANE to treat breast, non-small cell lung, pancreatic, and gastric cancers.

The company’s products also include IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (rrAML) with an isocitrate dehydrogenase-2 mutation; VIDAZA, a pyrimidine nucleoside analog for intermediate-2 and high-risk MDS, chronic myelomonocytic leukemia, and AML; THALOMID to treat patients with MM; and ISTODAX, an epigenetic modifier. Its preclinical and clinical-stage product candidates include small molecules, biologics, and cell therapies for immune-inflammatory diseases, myeloid diseases, epigenetics, protein homeostasis, and immuno-oncology.

The company has agreements with BeiGene, Ltd; Acceleron Pharma, Inc.; Agios Pharmaceuticals, Inc.; bluebird bio, Inc.; Lycera Corp.; Juno Therapeutics, Inc.; EXSCIENTIA LTD.; and IMIDomics SL, as well as immuno-oncology collaboration with Sutro Biopharma. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.