21 days old

Sr. Manager, QC Microbiology

Emergent BioSolutions Inc.
Baltimore, MD 21202


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 managements assignment of essential functions.

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

 Bachelors 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.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

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Posted: 2020-12-31 Expires: 2021-02-07

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Sr. Manager, QC Microbiology

Emergent BioSolutions Inc.
Baltimore, MD 21202

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