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 on the media prep team to execute the production processes in a cGMP manufacturing environment. The media prep team performs equipment preparation (parts washing, manifold prep, autoclaving) in addition to formulation of media and solutions to support Manufacturing operations. This role is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational challenges, as well as routine tasks in the production of bulk drug substance and bulk drug product for commercial GMP manufacturing.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Lead employees on the media prep 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 media preparation 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 Bioprocess Associates).
• Perform deviation investigations, review of documentation including batch records, solution preparation 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. 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.
• Develop technical expertise in area of responsibility and provide technical instruction/training on current and new/improved processes to appropriate audiences, primarily Manufacturing Bioprocess Associates.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelors Degree in Science or related field with minimum of 3-5 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
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.