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ASSOCIATE ENGINEER II

Bristol-MyersSquibb is a global biopharmaceutical company whose mission is to discover,develop and deliver innovative medicines that help patients prevail overserious diseases.
One shared journeyis moving us forward at Bristol-Myers Squibb.
Around the world, we arepassionate about making an impact on the lives of patients with seriousdisease.
Empowered to apply our individual talents and ideas so that we canlearn and grow together.
And driven to make a difference, from innovativeresearch to hands-on community support.
Bristol-Myers Squibb recognizesthe importance of balance and flexibility in our work environment.
We offer awide variety of competitive benefits, services and programs that provideour employees the resources to pursue their goals, both at work and intheir personal lives.
Bristol-MyersSquibb has announced plans for an expansion of its large-scale biologicsmanufacturing facility in Devens, Massachusetts.
The expansion will create amammalian cell biologics center of excellence through the introduction ofbiologics development and clinical trial manufacturing capabilities to thesite.
Both represent new capabilities for Devens, a site that in its earlyyears has focused solely on large-scale, bulk biologics manufacturing.
The Associate Engineer II serves as a processtechnical lead and subject matter expert to small/large scale cell culture andharvest unit operations for the commercial manufacture of biopharmaceuticals atDevens manufacturing.
The successful candidate will be key contributor to adynamic and highly technical team of engineers and scientists by settingappropriate objectives and priorities, overcoming obstacles; and deliveringresults within project timelines and will build and maintain effectivecollaborations with Manufacturing, Manufacturing Support, Process Development,Quality Assurance, Analytical and Global Regulatory Sciences groups.
Strongcommunication and technical writing skills are required.
The incumbent will lead the design and executionof experiments for design & control of large scale inocula, seed train,bioreactor, filtration and centrifugation unit operations.
Appropriate GLP/GMPprocedures must be followed.
This position also involves troubleshooting andproblem solving of process related problems observed at manufacturing scale andthe evaluation of new process technologies through the effective design ofscale-down studies and the evaluation of data from manufacturing lots.
Duties:
Provides technical expertise for investigationand resolution of upstream process deviations, root cause investigation, CAPAs,process improvements, scale-down model development, new technology evaluationand preparation of regulatory filings Demonstrates a strong knowledge of cGMPcompliance, BMS corporate, site and regulatory agency requirements andprocedures Supports process technology transfer, processvalidation and the preparation of CMC documentation for regulatory filings forBMS Devens Large Scale Cell Culture facility Authors technical documents, including protocols,reports and SOPs supporting the validation of the manufacturing upstreamprocess Participates in the preparation of regulatoryfiling documents and inspection readiness Provides process subject matter expertise forregulatory inspections and other interactions with regulatory agencies,representing the Devens site.
This position will be temporarily based inHopkinton, MA & requires routine travel between our Hopkinton & Devens,MA sites.
Qualifications B.
S.
, in the biological sciences orchemical/biochemical engineering, a related discipline, or its equivalent.
Graduate education through M.
S.
highly desired.
Minimum BS or equivalent with a minimum 4-6 yearsrelevant experience, MS or equivalent with minimum of 2-4 years relevantexperience in upstream manufacturing technical support or upstream processdevelopment in the biopharmaceutical industry Experience in contributing to the design,modification and optimization of cell culture or fermentation unit operations Proactively identifies problems and troubleshootssolutions Organizes and presents data for internal/externalscientific meetings Works independently and collaborates with othergroups Capable and willing to train others onprocedures, operations, new technology, methods or processes Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502424

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