Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Syracuse Quality Control (QC) Laboratories support the onsite small scale commercial manufacturing facility, as well as network and third party manufacturing facilities. The QC Supervisor provides operational and technical support to the QC laboratory by enabling continued cGMP compliant daily laboratory operations to meet customer needs.
This position is responsible for providing supervisory oversight in the functional area of expertise of Bioseparations methodologies within QC for the testing of raw materials, in-process manufacturing samples, and drug substance/drug product release and stability samples. A variety of duties are performed relating to the lean and effective functioning of QC laboratories. In addition, this role is responsible for communication with internal and external customers.
Responsibilities:
- Prioritize day to day activities and provide direction and support to team members
- Facilitate communication at team huddle meetings and escalate information to management as appropriate.
- Provide leadership to staff through demonstration of a quality culture and scientific excellence.
- Perform routine data review and safety/compliance verifications to maintain laboratory in cGMP compliant state
- Partner with Quality Assurance to perform laboratory investigations, determine root cause for laboratory errors, and identify appropriate corrective/preventive actions for laboratory errors.
- Perform testing and laboratory maintenance activities as required to support workload.
- Accurately document laboratory work and instruct other less experienced personnel on good documentation practices.
- Recognize anomalous trends or results within realm of experience and training.
- Develop/maintain processes in QC laboratories to support cGMP compliant testing, author/modify SOPs as required.
- Facilitate technical transfer and co-validation activities for test methods.
- Review technical protocols and reports.
- Perform basic troubleshooting of lab instrumentation. Have ability to recognize instrumentation issues and resolve them.
- Collaborate with appropriate laboratory, manufacturing, and other internal/external personnel to ensure accurate communication of information and that business needs/requirements are met.
- Review method/specification changes and work with staff to communicate updates.
- Develop job function training units, ensure staff learning plans are appropriate and staff training is kept current
- Maintain up to date knowledge on QC lab software applications and train less experienced team members on use.
- Become a qualified trainer for area of expertise.
- Lead/Participate on teams in support of business process improvements/operational excellence.
- Facilitate positive culture change with implementation of new processes.
- Present information at group/department meetings.
QUALIFICATIONS
Specific Knowledge, Skills, Abilities, etc.:
- Expert level applied knowledge and in depth understanding of analytical techniques preferred. Current bioseparation methodologies include a variety of HPLC, UPLC, iCIEF, and CE-SDS techniques. Experience with Empower chromatography software is strongly preferred.
- Demonstrated leadership ability.
- Self-directed with a high degree of professional integrity, very organized, and detail-oriented.
- Excellent problem solving ability, attention to detail, and analytical/critical thinking skills.
- Ability to prioritize objectives from multiple project, adhere to scheduled timelines while maintaining flexibility and attention to detail.
- Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
- Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
- Proficient with Microsoft Office Applications (Excel, Project, PowerPoint, Word) and/or other relevant software programs.
- Demonstrated ability to effectively train and assist other less experienced individuals.
Education/Experience/Licenses/Certifications:
- Minimum B.S. degree in a scientific area with 7 to 9 years’ experience, M.S. degree with 4 years’ experience. Experience is required working in a cGMP laboratory.
Physical Demands/Work Environment:
This position is a primarily an office based position, however, requires routine entry into laboratories to review data, test samples as needed, and access instrumentation. Walking within and between buildings is required to enter laboratories and collaborate with others. Lifting (not to exceed 50 lbs.) may be required. Office-based work requires sitting. Repetitive use of arms/hands/wrists, especially when working with a computer. This position is based indoors and you will be primarily working with others, however, will also work independently and alone at times. This position is a team-based position that may require weekends, holidays, and off shift work.
Entry into the laboratory setting requires appropriate levels of personal protective equipment (PPE) and may involve:
- Contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics.
- Handling of powdered materials and high temperature liquids and solids.
- Use of instrumentation, including instruments that have lasers.
- Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching.
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 the resources to pursue their goals, both at work and in their personal lives.
