Supervisor, Upstream Manufacturing
Company: Emergent BioSolutions
Posted on: January 17, 2020
Those who join Emergent BioSolutions feel a sense of ownership
about their future. You will excel in an environment characterized
by respect, innovation and growth opportunities. Here, you will
join passionate professionals who advance their scientific,
technical and professional skills to develop products designed-to
Supervises employees to execute the upstream production processes
in a cGMP manufacturing environment. Operations include thaw of
cells from vial, static cell culure (flasks and NCFs), bioreactors
(50 L and 500 L), Sweco/Harvestainer, centrifuge, autoclave, parts
washer. Supervise employees to build and prepare equipment
(CIP/SIP) and run production processes.
* Lead employees on the manufacturing floor within a process team
to meet the site goals and priorities. Provides daily job
assignments with manufacturing staff and other cross functional
* Supervise/Execute cGMP production activities to support the
upstream production activities. Maintain a high degree of
visibility and access to employees throughout the shift
* Ensures the proper and timely development and training of
employees. Responsible for performance management of 3-4 direct
reports (Manufacturing Associates).
* Perform deviation investigations, review of documentation
including batch records, logbooks and forms.
* Assures that operations are conducted in compliance with cGMPs,
CBER, WHO, EP and other regulatory bodies.
* Interface with the Quality Assurance, Maintenance, and Materials
Management departments to resolve production, supply, and equipment
issues. Document issues through deviations, as necessary
* Manage or own quality systems including deviations, CAPA's,
change controls, DCC's, etc.
* Develop technical expertise in area of responsibility and provide
technical instruction/training on current and new/improved
processes to appropriate audiences, primarily Manufacturing
Associates. Ability to work aseptically in a BSC.
* Assist the Validation and Maintenance staff with the operation
and execution of engineering projects. Provide technical expertise
for these projects.
* Implement and reinforce practices that make safety an ongoing
consideration for all operational activities leading to a safe and
clean room working environment. Attend all safety training and
exercise self-discipline to follow all EHS policies.
* Provide support to integrate best practices, where appropriate,
into manufacturing. Support process improvement initiatives.
The above statements are intended to describe the general nature of
work performed by those in this job. It is not an exhaustive list
of all duties, and other duties may be assigned.
Education, Experience & Skills
* Bachelor's Degree in science or related field with minimum of 5
years experience in cGMP or regulated environment
* A minimum of 2-3 years of supervisory responsibility in a GMP
Biotech environment is preferred
* Knowledge of cGMP and CFR requirements
* Strong communication skills: oral/written and listening
* Personal Competencies: Self-awareness, Integrity, Team player,
Creative, Highly Motivated
* Must be able to work in a complex matrixed environment
* Must be able to influence without authority across various
Type/keyboard, visual acuity, good eye/hand coordination, stand,
walk, sit, twist/turn, climb, reach outward, reach above shoulder,
hand dexterity, bend, squat/kneel, sense of feel, sense of hearing,
sense of smell, lift 50 lbs. Use phone, fax, copier, and computer.
Use hand tools. Organize/coordinate, analyze/interpret, calibrate
precise measurements, high level of attention to detail, problem
solve, make decisions, supervise, plan, communicate, prepare
Position requires vaccination against different viruses including
Vaccinia virus and Japanese Encephalitis virus. Position requires
weekend and evening hours as required to support the production
Emergent BioSolutions is an Equal Opportunity/Affirmative Action
Employer and does not discriminate on the basis of race, color,
religion, gender, age, national origin, disability, Protected
Veteran status, sexual orientation, or any other characteristic
protected by federal, state or local law.
Information submitted will be used by Emergent BioSolutions for
activities related to your prospective employment. Emergent
BioSolutions respects your privacy and any use of the information
Emergent BioSolutions does not accept non-solicited resumes or
candidate submittals from search/recruiting agencies not already on
Emergent BioSolutions approved agency list. Unsolicited resumes or
candidate information submitted to Emergent BioSolutions by
search/recruiting agencies not already on Emergent BioSolutions
approved agency list shall become the property of Emergent
BioSolutions and if the candidate is subsequently hired by Emergent
BioSolutions, Emergent BioSolutions shall not owe any fee to the
Keywords: Emergent BioSolutions, Boston , Supervisor, Upstream Manufacturing, Other , Canton, Massachusetts
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