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 Materials Operations Technical Specialist is to provide advanced documentation, equipment, investigative, and process support to the Materials Operations organization. The Materials Operations Technical Specialist will be the Materials Operations representative on various projects and cross-functional teams (include network project teams), will provide training, participate and/or lead in the implementation of new equipment and processes, author Change Control, BOM, and SOP/MBR changes. The Materials Operations Technical Specialist will execute lean and 6-sigma manufacturing improvements.
Duties/Responsibilities:
* Authoring of equipment and facility change controls, EHS change processes, and CAPA Action Plans
* Author, revise and approve critical Materials Operations documentation; i.e. MBRs, BOM, and SOPs
* Project validation support and execution
* Support Lean OpEx initiatives that align with site strategy
* Seek out process inefficiencies and implement solutions
* Development and execution of training materials for new processes and equipment in conjunction with the Site Technical Training team
* Support of Warehouse, Dispensary, and Cryogenics Operations, Tech Transfers, Process Improvements, global network projects and other teams as required
* Lead Materials Operations process improvement projects and interact with cross-functional groups to achieve departmental and organizational goals
* Adhere to all plant safety policies and procedures and proactively identify unsafe conditions
QUALIFICATIONS
Specific Knowledge, Skills, Abilities, etc:
* The position requires a strong understanding of cGMP and regulatory agency requirements and strong technical operational knowledge of materials operations relating to Biologics manufacturing
* Incumbent must have demonstrated experience in solving complex technical issues in materials operations relating to Biologics manufacturing, and have the skills and understanding to troubleshoot process equipment and the overall materials operations processes
* The role requires demonstration of successful participation on diverse work teams where combined contribution, collaboration and results were expected
* The position requires excellent written and verbal skills and the ability to provide direction and communicate expectations to the Materials Operations staff
* The candidate will have strong computer skills and be proficient in the following programs: Word, Excel, Visio
* The position requires the ability to work off-hours as needed to complete projects or key tasks requiring SME oversite
Education/Experience/ Licenses/Certifications:
* Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
* Direct biologic manufacturing experience of 4+ years
* Extensive knowledge of SOPs and GMPs and the know-how to work within a regulated environment
* Strong knowledge of biopharmaceutical manufacturing processes
* Adaptable to a fast paced, complex and ever-changing business environment
* Effective verbal and written communication skills with technical writing skills
* Proficiency in the use of computers and business software applications
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
Work Environment:
* Position is primarily office based with occasional work in a classified GMP manufacturing environment
* Position is a team and project based position that will require occasional shift work, weekends and holidays
Travel:
* This position requires minimal travel (< 5%)
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.
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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Summit, NJ
Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases worldwide. It offers REVLIMID, an oral immunomodulatory drug for multiple myeloma (MM), myelodysplastic syndromes (MDS), and mantle cell lymphoma; POMALYST/IMNOVID to treat multiple myeloma; OTEZLA, a small-molecule inhibitor of phosphodiesterase 4 for psoriatic arthritis and psoriasis; and ABRAXANE to treat breast, non-small cell lung, pancreatic, and gastric cancers.
The company’s products also include IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (rrAML) with an isocitrate dehydrogenase-2 mutation; VIDAZA, a pyrimidine nucleoside analog for intermediate-2 and high-risk MDS, chronic myelomonocytic leukemia, and AML; THALOMID to treat patients with MM; and ISTODAX, an epigenetic modifier. Its preclinical and clinical-stage product candidates include small molecules, biologics, and cell therapies for immune-inflammatory diseases, myeloid diseases, epigenetics, protein homeostasis, and immuno-oncology.
The company has agreements with BeiGene, Ltd; Acceleron Pharma, Inc.; Agios Pharmaceuticals, Inc.; bluebird bio, Inc.; Lycera Corp.; Juno Therapeutics, Inc.; EXSCIENTIA LTD.; and IMIDomics SL, as well as immuno-oncology collaboration with Sutro Biopharma. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.