Supervisor, Upstream Manufacturing

Company: Emergent BioSolutions
Location: Canton
Posted on: January 17, 2020

Job Description:

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 protect life.

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.

Responsibilites
* 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 departments
* 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 departments
Physical/Mental Requirements
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 written communications.

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 schedule.

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 submitted will be subject to the terms of our Privacy Policy .

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 submitting agency.

Keywords: Emergent BioSolutions, Boston , Supervisor, Upstream Manufacturing, Other , Canton, Massachusetts