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.
The Manager in Vaccine R&D Virology will have a critical lead role in a variety of research and development activities, including evaluation of new technologies and provides scientific support for pipeline R&D programs. The successful candidate will also support the development, qualification, and validation of pre-clinical and clinical assays, with primary focus on immunoassay testing of clinical and nonclinical samples. The main responsibilities will include design and execution of assays, management of laboratory quality systems, including data review, equipment and materials, samples and reagents, and documentation. Responsibilities will also include overseeing regulatory compliance during all laboratory testing activities. Must be able to multi-task, adapt, and be flexible in a fast-paced and demanding work environment. GxP-compliant documentation, organization, and accountability are key. Will work closely with R&D, Regulatory Affairs, and Quality Assurance groups to ensure timely delivery of data to meet project specific demands and requirements.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Contribute to the design and development of new pipeline vaccines.
- Evaluate new technologies or vaccines being considered for acquisition.
- Contribute to writing grant proposals to external funding sources & generate supportive data.
- Represent the company externally at scientific conferences and community science outreach events.
- Establish and manage relationships with external collaborators.
- Contribute to the preparation of scientific manuscripts for publication.
- Manage, support, and monitor equipment maintenance, calibration, and qualification
- Supervise development, optimization, qualification, and/or validation of immunoassays or other assays to support clinical trials and pre-clinical efforts
- Supervise/manage laboratory safety program, ensuring personnel compliance
- Maintain a quality program to oversee day-to-day operations, including sample handling and chain of custody, study planning, sample processing and data analysis, reporting, document control, storage, and retention of data
- Manage and support the preparation, organization, and archiving of laboratory documentation In conjunction with senior laboratory staff, manage and review the laboratory training records
- Write and review SOPs, worksheets, and checklists related QC compliance
Minimum Education, Experience and Skills
- PhD in a scientific discipline with minimum of 4 years experience or
- MS with 6 years experience in a research environment or
- BS with 8 years of relevant experience in a research environment with demonstrated scientific skill sets
- Able to effectively lead a team of researchers.
- Experience working in a regulated GxP laboratory environment
- Experience with Good Documentation Practice (GDP)
- Demonstrated experience with strict adherence to compliant procedures
- Industry experience with applied Biology, Cell Biology, Virology, or Immunology
- Excellent understanding of scientific methods and statistical analysis
- Ability to analyze complex data and come to valid scientific conclusions
- Experience with clinical programs from pre-clinical through trial testing, including clinical trial documents
- Thorough understanding of regulatory requirements, including ICH guidelines and CFRs
- Ability to plan project tasks effectively, keep to timeline and prioritize
- Have strong innovation, analytical thinking, and troubleshooting capabilities
- Ability to present effectively to internal and external audiences
- Be a proven team player with outstanding oral and written communication
- Ability to collaborate with research team and perform project specific experiments
- Productive, willing to take initiative, able to work in a collaborative team
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.