QC Scientist Molecular
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us
PURPOSE AND SCOPE OF POSITION:
The QC Scientist is responsible for performing as a subject matter expert in the completion of QC bioanalytical testing or data review for method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell therapy drug product.This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, the QC Scientist will be responsible for training and assay transfer.The QC Scientist role is stationed in Devens, MA and reports to the Senior Manager, QC Analytical Technical Support for the Devens CTF.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Advanced hands-on experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR) and scientific knowledge in the characterization, validation and transfer of bioanalytical methods.
- Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely.
- Advanced technical writing skills.
- Advanced problem-solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Advanced ability to communicate effectively with peers, department management and cross-functional peers. Ability to work with management locally and globally.
DUTIES AND RESPONSIBILITIES:
- Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples.
- Use scientific principles to assist with analytical testing methods and the proper use of laboratory equipment.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
- Subject matter expert for training new analysts to general job duties.
- Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.
- Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
- Own and evaluate relevant change controls, investigations, deviations, CAPAs.
- Lead complex projects and continuous improvement efforts.
- Prepare and present continuous improvement projects to management.
- Demonstrate initiative, courage, and continuous improvement throughout investigation/ corrective action lifecycles.
- Perform other tasks as assigned.
- Support for QC and manufacturing operations may include shift coverage consisting of on call, shift, and/or weekend coverage.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree required, preferably in science. Advanced degree preferred.
- 6+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
- Working knowledge of LIMS.
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 firstname.lastname@example.org. 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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