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.
I. JOB SUMMARY
Responsible for managing and oversight of routine and non-routine microbiological activities. This includes scheduling and execution of the environmental monitoring testing program, utility testing program, raw material, in-process, and product release testing requirements and well as ensuring adequate resources to support non-routine method qualification, area re-qualification, growth promotion, and reagent control activities.
The manager will provide support in transferring new microbiological projects into the Bayview site and maintain routine analysis and release of product. The manager will serve in supporting other Emergent sites as needed and support documentation required to conduct laboratory and data services in a complaint manner.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Manages the Microbiology laboratory support of production by ensuring the timely release of manufacturing areas, utilities, raw materials, in-process, and finished products
• Serves as the technical subject matter expert on microbiological assays and techniques
• Defines and manages the activities of the Microbiology Laboratory to assure that all test samples meet the raw materials, intermediate, final product, and stability specifications
• Provides expertise and troubleshoots microbiology related issues for EMOB
• Authors, reviews, and approves SOPs, validation protocols, investigations, and batch records specifications as they relate to this department
• Work with the Microbiology staff to author Microbiology related deviations, CAPA, OOS, and OOL investigations
• Responsible for cGMP compliance of the laboratory and personnel
• Define the development needs in the Microbiology Laboratory
• Represent microbiology in meetings with Production, Quality Assurance, Engineering, Regulatory Affairs, and other related departments
• Provide industrial microbiology regulatory/technical guidance to site
• Advises, recommends, and implements resolutions for quality problems and regulatory commitments to site management
• Interact with other departments as required to define and/or verify the scope of work for a project; i.e. Provide testing services for validation work
• Responsible for the scientific and managerial training for the staff to assure a competent, professional, and committed work force. Recommends promotions and salary increases as deemed necessary
• Ensure the completion of projects within budget limits and time projections
• Participate in and attend professional seminars, conferences, and conventions
• 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.
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor's Degree in Microbiology/Biology or related field
• Minimum of 10 years of experience, including 5 or more years of supervisory responsibilities in Pharmaceutical industry with emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, cGMP, validation, and manufacturing processes
• Must have previous hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, Enhancement and Inhibition, LAL, Sterility, and Bioburden Testing
• Competent in the use of various computer programs of Microsoft Access and Excel
• Excellent communication, documentation, and organization skills
• In depth knowledge of FDA regulations pertaining to cGMPs, international regulations, and industry practices
• Experience performing extensive investigations related to microbiology/biology issues
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.