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.
POSITION SUMMARY:
The primary role of the Manufacturing Technology Associate/Scientist/Engineer is to conduct high quality root cause analysis investigations of GMP Quality Events. The Level of responsibility and complexity of investigations and additional projects undertaken will typically increase with grade level.
Duties/Responsibilities:
•Lead Quality Event Investigations to determine root cause, assess product impact and determine CAPA
o Conduct assessments of quality events to evaluate the potential for SISPQ Impact
o Conduct root cause analysis for quality events with potential SISPQ impact
o Complete product impact assessments for quality events
•Identify opportunities for improvement of process performance and/or quality event reduction through CAPA development
•Support projects for productivity, robustness, quality, business process, and safety improvements
•Author and review technical documents including protocols/technical reports, SOPs and risk assessments
•Support MT initiatives, such as process performance monitoring, process improvement projects and evaluations to identify process risks and suggest recommendations for process robustness and/or remediation
QUALIFICATIONS
Specific Knowledge, Skills, Abilities, etc:
•Experience in problem solving ability and ability to apply risk-based critical thinking in technical environment
•Ability to collaborate across technical teams and good interpersonal skills
•Technical communication skills in a written and presentation format are essential
•Ability to work with management to appropriately prioritize and complete deliverables within given timelines
•Good organizational skills and attention to detail with high quality output
Education/Experience/ Licenses/Certifications:
•Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing: Minimum of a B.Sc/B.Eng with 2+ years or a M.Sc/M.Eng degree with 0-2 years of experience
•Knowledge of biologics manufacturing and/or GMP investigations is preferred
Physical Demands:
•Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs.
•Occasional bending, twisting and stooping to allow for gowning into classified environment required
Work Environment:
• Position is primarily office based with occasional work in a classified GMP manufacturing environment
Travel:
This position requires <5% of travel.
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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Job ID: 42362
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