Sr. Specialist, Quality Control
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.
This Position qualifies for a $10,000 Sign-on Bonus, $5,000 payable within 30 days of start date and $5,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.
Purpose and Scope of Position:
The Quality Control Senior Specialist is responsible for supporting the release, stability, and in-process testing of Cell Therapy clinical and commercial products with the Quality Control department. This includes the ability in interface with multiply groups, provide technical support and troubleshooting, and when needed provide support for training and method transfers.
*This is a Sunday- Wednesday pm shift: 1:30pm- 12:00am*
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Bachelor’s degree required, preferably in the physical or life sciences.
6+ years of relevant work experience in a regulated environment with 2 years' experience within a cGMP environment.
Knowledge, Skills, and Abilities
Advance technical experience in cell and molecular biology techniques such as cell-based assays, flow cytometry, qPCR, and/or ELISA.
Act as a subject matter expert in cell-based bioassay methods.
Execute troubleshooting techniques and help support junior analysts.
Provide the technical expertise in support of method transfer/ validation activities for the QC network or for ongoing incoming, in-process, release, and stability testing.
Reviews or writes technical reports and perform data analysis and trending for both method transfers and investigations.
Recognize and troubleshooting of bioassay method excursions. Provide guidance for equipment troubleshooting as needed.
Author/lead revisions to SOPs for managerial review and approval. Author protocols/reports as required.
Performs investigations for OOS, data analysis for method transfers and process investigations, assists in troubleshooting lab procedures and taking required corrective actions.
Works according to cGMP requirements.
Extensive knowledge and understanding of regulatory standards as they apply to GMP laboratories.
Ability to communicate effectively with peers, cross-functional peers, and management.
Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
Ability to represent the interest of the group on cross-function teams.
Experience with LIMS and ELN computer applications.
DUTIES AND RESPONSIBILITIES:
Knowledge of science generally attained through studies resulting in a BS in physical or life sciences (e.g., chemistry, biochemistry, molecular biology, or related discipline) or its equivalent is required
Possess a strong expertise in cell-based bioassay, operational knowledge of analytical instruments to support
Familiarity with method validations and procedures and method development history; proficient in lab software application such as LIMS.
Knowledge of US/EU Requirements and industry best practices
Develops strategies for solving complex problems
Front room FDA/Inspectional experience on systems, QEs, method transfers etc.
Ability to work across intra and inter functional departments to achieve alignment of company objectives.
Perform testing and data review of in-process, final product, and stability samples of cell therapy product in accordance with applicable procedures and cGMP requirements.
Ensure timely completion of testing and tasks as assigned.
Capable of handling complex issues, solving problems and troubleshoot with minimal guidance.
Author and revise technical documents such as test methods, SOPs, specifications, and/or sample plans as appropriate.
Support method transfers, method validation, and new instrument implementation by representing site QC in cross-site protocols reviews and approval.
Own and lead Deviation, CAPA, Laboratory Investigations, and Change Controls.
Train and mentor others on Quality Control test methods and processes.
Champion and foster a positive and successful collaborative quality culture.
Lead the design, implementation and continuous improvement projects for Quality Control systems and processes that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
WORKING CONDITIONS (US Only):
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
Work in areas that may have strong magnets.
May work in areas with exposure to vapor phase liquid nitrogen.
Must have ability to work assigned shift (Day, Night, Weekends and/or holidays).
Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
Require to work in and around laboratories and controlled, enclosed, restricted areas, included clean rooms.
Require to carry and/or lift up to 10 pounds several times a day.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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