Sr Associate, Manufacturing Technology - SUF (R1549010-en-us)
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.
Reporting to the Senior Manager of Manufacturing Technology SUF, is to serve as a process technical expert for upstream and downstream purification supporting late-stage and commercial manufacturing of biologics drug substance. The successful candidate will be a key contributor to a highly technical, diverse, and collaborative team of scientists and engineers by setting appropriate objectives and action plans, overcoming obstacles, and delivering results to meet established timelines. The Senior Associate contributes to cross-functional teams to meet highly visible business objectives. This position offers the opportunity to interface with Manufacturing, Engineering, Process Development, Quality, Analytical, and Global Regulatory Sciences groups. Demonstrated skills in cross-functional partnerships, supporting cross-functional teams and knowledge of regulatory and cGMP requirements are required.
Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, review and approval of change controls and preparation of regulatory filings.
Performs root cause investigations and develops CAPAs as needed for process deviations.
Develops process performance data trending for continuous process verification and process improvement.
Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures and incorporate into all assigned projects.
Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Large Scale Cell Culture facility.
Authors technical documents, including protocols, reports and SOPs supporting the validation of the biopharmaceutical product manufacturing.
Serve as an effective partner for manufacturing groups, bringing technical expertise from development and MS&T lab groups to the manufacturing floor, and relaying the voice of the operations staff back to development and MS&T lab scientists.
Routinely liaises with MS&T Process Champions, SUF Manufacturing Operations, and Devens MS&T regarding strategies for technical and operational improvements, investigation resolution, and process validation.
Participate in cross functional project teams to drive complex process improvement or to enable or enhance organizational capabilities.
Actively communicates group’s activities and progress through varied technical and non-technical forums.
Qualifications & Experience:
BS in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
BS or equivalent with 2-4 years relevant experience, MS or equivalent with 0-2 years relevant experience.
Knowledge of process engineering and science generally attained through studies resulting in a B.S. in engineering, a related discipline, or its equivalent.
Knowledge of SOPs, cGMPs and the knowhow to work and manage within a regulatory environment.
Experience in designing and executing process and equipment validation plans
Knowledge of biopharmaceutical facility design and manufacturing operations. Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is desirable.
Successful experience in project management including proficient use of project management tools and software such as MS Project and other collaborative systems.
Proven experience in successful execution of process technical transfer
Experience in the design, modification and optimization of biologics purification processes
Experience in investigating process deviations and developing issue resolving CAPAs
Excellent verbal & written communications skills. Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization
Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
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 firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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