Senior Specialist, Quality Control Cambridge - MA - US R1605098 Posted 18 hours ago

## Senior Specialist, Quality Control Cambridge - MA - USFind out how well you match with this job
** 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. 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:
** Position Summary
** The Senior Specialist will serve as the designated subject matter expert for a number of test methods/processes across multiple products, anticipate and perform complex troubleshooting and problem-solve independently.

This role will own generation of protocols and reports, and other documents aligned with regulatory and corporate guidelines. The Senior Specialist will also represent the department in product review boards and regulatory inspections, both internal and external, and may author responses to regulatory requests.

They will lead transfers, validations, projects, CAPAs, and deviations/investigations, and continuous improvement efforts.

Furthermore, the Senior Specialist will train and mentor others on multiple QC test methods, processes, and procedures and perform other tasks as assigned.
** Responsibilities:
*** Designated Subject matter expert for a number of test methods/processes across multiple products
* Leads method transfer & validation of in-process, final product, and stability methods
* May own scheduling of assignments in consultation with manager.
* Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
* Represent the department in product review boards and regulatory inspections (internal and external audits).
* May author responses to regulatory requests.
* Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts.
* Anticipate and perform complex troubleshooting and problem solving independently.
* May represent the department in regulatory inspections (internal and external audits).
* Train and mentor others on multiple QC test methods, processes and procedures.
* Perform other tasks as assigned.
* Owns and contributes to change controls.
* May act as delegate for laboratory management, as required.
* Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
* Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation.
* Champion and foster a positive, supportive, and collaborative quality culture.
* Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
* Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).
** Qualifications
* ** Bachelor's degree required, preferably in a chemistry, life science, or related discipline with 9+ years relevant experience. An equivalent combination of education and experience, preferably in a regulated environment will be considered.
* Past experience with quality control, preferably with focus on stability
* Hands-on experience on with at least one of the following analyses: mRNA, LNP, Potency assay, Flow Cytometry, PCR, ELISA, and/or HPLC is required
* Good understanding with cGMP, GDP and GLP regulations and guidelines
* General experience in data analysis and statistical evaluation/data trending
* Scientific knowledge and direct…