Specialist, Transfer Analyst, QC NPI Chemistry
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.
The Specialist, Transfer Analyst , QC New Product Introduction Chemistry, is responsible for executing protocols for
method validations, verifications, and transfers for the Quality Control laboratory. The position will perform routine
release testing of both material and finished product in support of the larger product introduction activities, e.g. area
qualification and process performance qualification. This position will work with network and local resources to
accomplish transfer activities, including instrument installation. The position will facilitate the technical transfer from
the transfer team to the routine QC Operations team including analyst training. The position will report to QC New
Product Introduction Chemistry and Tech Services management.
• Perform testing of raw material, in-process, finished product samples in support of transfer/qualification.
o Perform various wet chemistry and analytical chemistry methods.
o Execute protocols, methods and procedures with adherence to cGMP documentation requirements.
o Complete all work assigned in a timely manner.
o Work and communicate effectively within the team to ensure timelines are met.
• Assists with peer review, verification, and approval of data
o Serves as technical reviewer of appropriate departmental procedures
o Reviews and approves documentation as required by laboratory procedures
o Performs verification of software templates and custom fields
o Performs peer review as needed for QC New Product Introduction Chemistry and Technical Services projects
• Performs modifications to QC lab electronic systems, including custom field development
• Work with QC leadership to identify equipment needs.
• Work with vendors to obtain quotes and initiate capitol asset requests.
• Participate in cross functional teams to execute induction and method transfer process.
• Own Change Management records related to instrument induction and decommissioning.
• Coordinate and assist with documentation activities for new procedures.
• Performs other tasks as assigned.
Qualifications & Experience
• Required Competencies: Knowledge, Skills, and Abilities
o Hands on experience with various analytical techniques and scientific knowledge in the characterization of pharmaceutical drug products.
o Intermediate ability to accurately understand, follow, interpret and apply Global Regulatory and cGMP requirements.
o Technical writing skills.
o Organizational and time management skills.
o Knowledge of laboratory instrumentation.
o Demonstrated ability to communicate effectively with peers, department management and cross-functional peers.
Education and Experience
o Associates or bachelor’s degree preferred, preferably in scientific field
o 1-3 years experience preferred
o An equivalent combination or education and experience may substitute
o Ability to work with moderate supervision
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.
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