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Downstream Clinical Shift Supervisor

Reporting to the Associate Director, Devens Clinical Manufacturing, the Shift Supervisor of Downstream 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:
1.
Leads the operation of all areas specific to production equipment (buffer preparation, chromatography, column packing and TFF), process automation systems (Delta V and Syncade Interactions, OSI/Pi Historian) and supporting business systems (SAP, Trackwise, Maximo).
2.
Ensures team adherence to Good Manufacturing Practices and standard operating procedures.
3.
Ensures daily work coordination and distribution of work to team members to accomplish the production schedule.
Act as an area/system owner - a point of contact for all work to be carried out for the area over assigned shift.
Manage decisions- acquire feedback, input, and consult as required 4.
Manages daily communication to shift personnel, drives shift huddles and supports functional team meetings.
Provides shift handover support in working with other shift supervisor/manager.
5.
Provides coaching, mentoring and development of staff.
Manage performance by being accountable for the preparation of performance connections objectives and for the mid-year and EOY performance connection review process 6.
Drives continuous improvements and a safety culture through staff engagement Qualifications o Scientific knowledge generally attained through studies resulting in a B.
S.
, in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
o Direct biologic manufacturing experience in purification for 6+ years with minimum of 2+ years of previous supervisory experience.
Candidate must possess the ability to effectively develop personnel.
o Extensive knowledge of SOPs and cGMPs and a demonstrated ability to work and manage within a regulatory environment.
Good technical writing skills required o Adaptable to a fast paced, complex and ever changing business environment.
Experience with single use technology in a GMP environment is a plus.
o Effective communication with support groups (Development, Quality, Tech Services) to obtain needed cooperation and collaboration to meet key milestones and objectives.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1502286

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