Specialist, QC Separations
Posted 8 hours 54 minutes ago by PVH (Tommy Hilfiger/Calvin Klein)
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 SummaryBristol-Myers Squibb Cruiserath Biologics is seeking to recruit a QC Biologics Specialist to join the QC-Separations Laboratory, the function of which is to support drug product and drug substance release testing, and Stability testing. The successful candidate will be involved in assisting in laboratory operations, performing testing of samples and performing laboratory duties in accordance with cGMP regulations.
Responsibilities will include (but not limited to):- Perform release and stability testing for drug substance and drug product samples in accordance with approved methods and cGMP requirements.
- Perform routine data analysis and review results based on demonstrated assay proficiency.
- Accurately document all laboratory activities in approved systems, ensuring data integrity and compliance with ALCOA+ principles.
- Assist with updating, reviewing, and approving controlled documentation, including SOPs, protocols, and reports.
- Identify, investigate, and document Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation events in line with quality systems.
- Support preparation, execution, and documentation of technical transfer, co-validation, and method lifecycle activities
- Support engineering, PPQ, and stability campaigns, including prioritisation of testing to meet business timelines.
- Contribute to continuous improvement initiatives, inspection readiness, and audit support activities within the QC Separations lab.
- Adhere to all site safety, data integrity, and quality policies, and actively promote a safe and compliant laboratory environment.
- Work effectively within a cross-functional, team-based environment, demonstrating strong communication and collaboration skills.
- The ideal candidate should hold a minimum of a BSc. in Biochemistry or related discipline.
- Previous experience in a regulated biopharmaceutical laboratory is preferred. HPLC/UPLC and Empower experience is preferred but not essential.
- The successful candidate must demonstrate an ability to work independently and recognize anomalous trends or results.
- Must demonstrate problem solving ability, as well as the ability to prioritize objectives from multiple projects and adhere to scheduled timelines. Excellent communication and the ability to work in a team based collaborative environment are required.
Bristol-Myers Squibb is an equal opportunities employer.
Why you should apply- You will help patients in their fight against serious diseases
- You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
- You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
With a single vision as inspiring as 'Transforming patients' lives through science ', every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your