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Scientist, Quality Control Microbiology Cell Therapy

Employer
Bristol Myers Squibb Company
Location
Summit West, NJ, United States
Start date
Sep 30, 2020

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Discipline
Quality, Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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.

POSITION SUMMARY

This position will work both independently and with the team to perform routine and non-routine Environmental Monitoring functions and support of Microbiology labs with microbiological testing, microbiology laboratory maintenance functions, projects and compliance related activities. This is a Monday-Friday, 1st Shift position.

PRIMARY DUTIES/RESPONSIBILITIES
  • Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
  • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
  • Follow directions properly, work cooperatively as an individual contributor and as a team member.
  • Communicate effectively with QC peers, cross-functional peers and management.
  • Assist in troubleshooting and solving problems that may come up in the day to day operation of the department.
  • Participate in Aseptic Process Validations/ Media Fills.
  • Perform Sterility Testing and sample aliquoting.
  • Perform Viable and Non-Viable air monitoring viable surface monitoring.
  • Perform and lead Environmental Monitoring Performance Qualification and Aseptic Qualifications.
  • Perform Environmental Monitoring as needed.
  • Perform microbial identification via polymerase chain reaction (PCR).
  • Perform microbial isolation techniques and perform gram stains.
  • Send out samples to contract labs and track results/reports.
  • Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
  • Support Endotoxin and Mycoplasma assays as needed.
  • Performs general laboratory cleaning/wipe-down.
  • Perform routine maintenance of lab equipments.
  • Maintain lab inventory and order lab supplies and materials.
  • Receives and stock test reagents, lab supplies and test media.
  • Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices.
  • Support/lead continuous improvement projects related to QC.
  • Under minimum supervision, support/lead special projects as needed.
  • Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports as needed.
  • Support investigations &CAPAs associated with QC Microbiology Department.
  • Lead change controls activities.
  • Support data trending and tracking of results.
  • Take ownerships/accountability of assigned tasks and come up with solutions/improvement suggestions.
  • Perform all other duties as assigned by Management.


EDUCATION/EXPERIENCE REQUIREMENTS
  • Requires Bachelor's degree in Microbiology, Molecular Biology, or related discipline. Master's Degree is strongly preferred.
  • Minimum 5-7 years of experience working in a regulated manufacturing environment.
  • Environmental Monitoring and Microbiology lab experience required.
  • An equivalent combination of experience/education is acceptable.
  • Have thorough understanding of USP, EP, JP, and FDA microbiology testing requirements.
  • Proficiency in Microsoft Word, Excel, PowerPoint and project management tools.
  • Responds to challenges and additional workload in an understanding, professional and objective manner.
  • Adaptable to dynamic conditions, work practices, tight project timelines and changing schedules.
  • Ability to multitask, prioritize workload, document properly and interpret data accurately.
  • Able to communicate effectively with GDPO functional areas and external agencies.
  • Excellent writing and presenting skills.
  • Flexible and willing to do all assigned tasks with positive attitude and under minimal to no supervision.
  • Support junior staff members, show team spirit and step up as needed.


Working Conditions
  • The incumbent will be required to wear uniform/ PPE for long durations in the manufacturing or laboratory environment.
  • The incumbent may be required to stand and walk for extended amount of time.
  • The incumbent may be required to work hazardous materials and areas with magnetic and electric fields.
  • Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must to accommodate business needs.
  • Change to work timings and assigned tasks may occur at a very short notice to support business needs.


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.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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