Director, Potency Assays - Vaccines

Ology Bioservices, Inc.
Job Description
DESCRIPTION

Summary:

The Head of the Potency Assay group within the Vaccine franchise will:

  • Establish Resilience as a leader in vaccine analytical science through the application of processes, procedures and technologies in the development of best in class testing strategies.
  • Lead the validation and technical transfer of state-of-the-art analytical techniques in support of advanced characterization of Resilience vaccine products.
  • Establish leadership across industry working groups and with regulatory agencies to advance Resilience's vaccine development and manufacturing goals.
  • Interface directly with customers to evaluate requirements and identify opportunities within development programs.
  • Manage a mix of senior and junior staff in the development of novel analytical methods.
  • Collaborate with analytical groups in other Franchises to develop best practices.

Responsibilities:

  • Development and qualification of molecular, ELISA and cell-based assays in support of vaccine testing.
  • Providing analytical characterization support within the Resilience organization and with external groups.
  • Utilize external networks to maintain and enhance current knowledge of emerging technologies in potency assay development to support improvements for existing analytical strategies.
  • Responsible for building and managing Resilience's Potency Assay group, including talent recruitment.
  • Communicating technical information to internal and external partners.
  • Writing and reviewing technical documents and regulatory submissions
POSITION REQUIREMENTS

Qualification:

  • Strong scientific background with extensive hands-on experience in a broad array of molecular, immunological, and cell-based techniques is required.
  • Extensive experience with experimental design, data analysis, organization and presentation of complex scientific data.
  • The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
  • Established external network of service providers, technical experts, suppliers, and technology providers.
  • Ability to recruit, lead, manage, and motivate a diverse team across various functions. Demonstrated ability to work efficiently across multiple project teams and business functions.

Preferred:

  • PhD and a minimum of 8 years experience or MS and a minimum of 10 years experience in vaccine or biologics assay development
  • Demonstrated experience managing teams in a matrix environment preferred.
  • Excellent written and verbal communication skills
NUMBER OF OPENINGS 1  
EOE STATEMENT Ology Bioservices,is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.

EEO Minorities/Women/Disabled/Veterans  
ABOUT THE ORGANIZATION Thank you for your interest in joining the Ology Bioservices team! We believe we have the most talented and committed employees in the industry with decades of combined experience in manufacturing, developing and licensing vaccines and protein/antibody therapeutics.
Ology Bioservices is a full-service Contract Development Manufacturing Organization specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in our state of the art Advanced Development and Manufacturing ADM) facility in Florida. Ology Bio has 20 years of experience developing and manufacturing drugs and biologics for the US Government, and over $500M in government contracts awarded over that time.
The company expanded to Commercial Manufacturing upon the move into the new facility in early 2017. Our infrastructure provides unique services to our clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3).
We offer outstanding career growth opportunities, excellent fringe benefits, and competitive pay.
We are an Equal opportunity Employer
AA/EEO Minorities/Women/Disabled/Veterans  
POSITION Director, Potency Assays - Vaccines  
LOCATION Alachua  
Contact Information