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UPSTREAM BIOPROCESS SPECIALIST

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
Reporting to the USP Supervisor, Devens Clinical Manufacturing, the Bioprocess Specialist of Upstream Clinical Manufacturing is responsible for advancing the mid to late stage clinical pipeline according to established work instructions and in accordance with current Good Manufacturing Practices (cGMPs).
The Clinical Manufacturing Building (CMB) is a brand new, state of the art facility utilizing single-use technology.
Key Responsibilities Include:
Weighs and checks raw materials.
Assembles, cleans and autoclaves process components.
Leads in maintaining material and component inventory levels.
Operates primary production equipment to complete process steps including media preparation, aseptic transfers, and cell culture and harvest operations in a clean room environment.
Adheres to Good Manufacturing Practices and standard operating procedures.
Recognizes deviations from accepted practice and communicates to area management.
Champions area specific initiatives and engages in creating a safe work environment.
Works on more complex manufacturing assignments per written procedures with minimal instructions.
Revises and creates process documents, i.
e.
SOP's and Batch Records, with no instruction and supports process related investigations.
Effectively uses in process automation systems (i.
e.
Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.
e.
SAP.
Trackwise, Maximo etc.
) to maintain production records.
Assists with reviewing batch and exception reports associated with each manufacturing lot, in conjunction with supervisor and Quality representative.
Qualifications Knowledge of science generally attained through studies resulting in a B.
S.
, in engineering, biochemistry or science related discipline is desired but not required.
A minimum of 5+ years of upstream process operations experience in a biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
Strong knowledge of regulations such as GMP's and company Standard Operating Procedures (SOP).
Previous experience with single use technology a plus.
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
Maintains a professional and productive relationship with area management and co- workers.
Demonstrates good interpersonal skills, is attentive and approachable.
Takes responsibility for personal safety , contributes to establishing a safe workplace environment and mentors junior manufacturing staff.
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502359

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