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Microbiology Lab Manager

Date: Mar 8, 2019

Location: Birmingham, AL, US

Company: Evonik Industries AG

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VACANCY REFERENCE NUMBER 114665
 

Microbiology Lab Manager

 

Location: United States : Birmingham, AL

Function: Innovation Management (R&D); Production & Technology

Career Level: Experienced professionals (2-5 years)

Legal Entity: Evonik Corporation

Business Line: Health Care

 

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

Click here to learn more about Evonik from our employees

The Manager, Microbiology will manage and provide administrative and technical leadership to the personnel and activities of the Microbiological Laboratory in support of all testing requirements necessary for the manufacture of pharmaceutical excipients and parenteral controlled release Finished Dosage Forms (FDFs) as part of the highly regulated Pharmaceutical Industry in addition to the routine microbiological facility monitoring.  

The support and activities include the sampling and testing of utilities (WFI, Clean Steam) and manufacturing facilities, release testing of key raw materials and products, participation in method transfers from customers or other Evonik HC sites into the microbiology laboratory, and support and testing as necessary to ensure compliance with the regulatory requirements at Birmingham. The responsibilities include reviewing analytical work, conducting technical interactions with subcontractors, overseeing the budget, hiring of personnel, monitoring the work and performance of personnel in the micro lab.

The team works closely with the quality assurance, EHS, engineering and manufacturing teams to ensure the successful development and commercialization of pharmaceutical products. These management responsibilities may involve microbiological support for client-funded research and development programs as well as internally-funded Internal Research and Development (IR&D) programs. 

RESPONSIBILITIES

  • Development and maintenance of metrics to monitor operational efficiency and capacity.
  • Planning for and accountability for component financial metrics.
  • Ensuring that the operations are fully compliant with all applicable regulatory and safety requirements (cGMP, OSHA, CHP, etc.)
  • Develops procedures/processes to outline how the group will execute on internally and externally funded projects
  • Identifies gaps within the current microbiology organization and proposes strategic alternatives
  • Applies appropriate regulatory guidance by considering development stages as well as internal and client requirements to ensure the successful progress of pharmaceutically acceptable products
  • Work effectively with internal and external customers to ensure their needs are met.
  • Proactively seek feedback from the customer regarding the quality and timeliness of services
  • Provide both personal and technical leadership to the micro staff.
  • Work constructively with upper management to further elaborate and implement a strategic vision for the operation.
  • Effectively communicate with and influence customers to achieve improvements in the transfer of methods into the Microbiology Laboratories  and in the management of routine workflows
  • Work effectively with internal and external customers to ensure their needs are met.
  • The primary point-of-contact with manufacturing managers on technical/scientific discussions regarding the environmental monitoring program for the manufacturing facilities and the microbiological testing of raw materials and finished product.
  • Proactively seek feedback from the customer regarding the quality and timeliness of services
 

REQUIREMENTS

  • BS/MS in microbiology
  • Minimum 10 yr. experience in a pharmaceutical microbiology laboratory
  • Knowledge and understanding of cGMPs required
  • Experience with bacterial endotoxin, bioburden and sterility testing required
  • Environmental monitoring experience required
  • Experience of manufacturing water and utilities testing required
  • Knowledge and understanding of microbiology method development and validation
  • Excellent written and verbal communication skills
  • Excellent organizational skills
  • Excellent computer skills including experience with spreadsheets and databases.
  • Ability to work with microorganisms and hot liquids.
  • A demonstrated ability to propose, plan, design, organize, conduct, supervise, and report on technical programs; a demonstrated ability to successfully meet and achieve goals and objectives with consideration of budget and time schedules for technical activities of appropriate scope and complexity.
  • A demonstrated ability to effectively communicate and interact with technical and non-technical client representatives.
  • A demonstrated technical capability in the microbiology and biological sciences areas.
  • A demonstrated ability to supervise, train, and manage technical staff.
 

Your Application

To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.

VACANCY REFERENCE NUMBER 114665

Evonik Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.

Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.
 


 


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