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.
SUPERVISOR, MANUFACTURING OPERATIONS UPSTREAM
Emergent BioSolutions is currently seeking a Supervisor, Manufacturing Operations Upstream at our Canton location. The successful candidate will have a bachelor’s degree in Science or another related field with a minimum of 5 years’ experience in a cGMP or regulated environment and a minimum of 2-3 years of supervisory responsibility, preferably in a GMP Biotech environment. Must have strong communication skills, be able to work in a complex matrixed environment and influence without authority across various departments. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.
Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.
As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.
We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.
Supervises employees to execute the upstream production processes in a cGMP manufacturing environment. Operations include thaw of cells from vial, static cell culture (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 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:
- Bachelors 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
Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
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.