Sr Manager, In Vivo Testing
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.
This position supports pre-clinical and advanced development of biologics and vaccines, for chemical and biological defense and emerging infectious diseases through managing non-clinical studies and key contract testing lab relationships. Key responsibilities include design, execution, and monitoring of non-clinical studies aimed at meeting regulatory requirements for approval/licensure of biologics and vaccines, as well as analysis, interpretation, and presentation of the data obtained in the course of these studies. The incumbent also directly contributes to regulatory filings and interactions with regulatory agencies, participates in the evaluation of and response to U.S. Government RFPs, RFIs, and RFAs in support of new and existing products, as well as provides technical due diligence support for merger and acquisition activities.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Supports non-clinical development of vaccines and anti-infectives (anti-bacterials and anti-virals), particularly those in the infectious disease and biodefense countermeasure pipeline.
• Responsible for the design and implementation of non-clinical studies to meet regulatory requirements for approval/licensure of biologics and vaccines.
• Responsible for project management and budgeting activities related to non-clinical development of products, establishes operational objectives for specific non-clinical programs.
• Ensures success of projects through interaction with Project Management, Regulatory Affairs, Quality Assurance, Clinical Development, and contract research organizations.
• Participates in the development of regulatory strategy; contributes to regulatory filings in support of development and approval/licensure of biologics and vaccines; participates in interactions with U.S. and foreign regulatory agencies.
• Prepares for and participates in meetings with FDA, EMA, and other regulatory agencies.
• Maintains knowledge base around the state of the art pertaining to development and use of animal models in vaccine and anti-infective development.
• Identifies, evaluates, and compares internal and external resources to arrive at the most efficient means of executing projects and ensures their success through the oversight of scientists, project managers and CROs.
• Ensures compliance with the applicable federal, state, and local regulations, as well as compliance of employees with the applicable Company rules and regulations.
• Authors and reviews SOPs, business operating procedures, business practices, and guidelines.
• Authors manuscripts and presents data at scientific meetings.
• Serves as a non-clinical subject matter expert on multifunctional product development teams.
• Presents progress and scientific data to senior management and U.S. Government and NGO funding agencies.
• Participates in the evaluation of and response to U.S. Government RFPs, RFIs, and RFAs in support of new and existing products.
• Provides technical due diligence support for merger and acquisition activities.
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Advanced degree Ph.D. or M.S. in Biology, Microbiology, Immunology, Biochemistry, Toxicology, Animal Science or related discipline
• A minimum of 5-8 years of experience in pre-clinical/non-clinical development of drugs and biologics, particularly design and execution of in vivo efficacy, immunogenicity, pharmacokinetics, pharmacodynamics, and toxicology studies
• Minimum of two years of experience in GLP-regulated animal research or testing (pharmacology/toxicology preferred)
• Effective organizational and interpersonal skills, as well as excellent written and verbal communication skills are essential, including proven track record of writing scientific and regulatory documents
• Working knowledge of principles of project management, including earned value management (EVM), is preferred
• Experience overseeing work performed by CROs is desirable
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.