Job OverviewWe are seeking an experienced nonclinical drug development professional to serve as a Senior Director, Scientific and Portfolio Global Biologics within our Manufacturing Solutions business unit.
The Biologics Testing team is hiring an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance now medicines through various stages of the development process. This position provides opportunity for independent scientific guidance and leadership roles within project teams and functional areas across the organization, with an emphasis on providing innovative advice on clinical and commercial (raw materials, drug substance and drug product) drug development programs across biologics, advanced therapeutics, nucleic acid modalities using a variety of methods. This position offers a stimulating and dynamic work environment, flexibility in work schedule, and opportunities for professional development and leadership growth.
- This position is remote and open to candidates based in the United States or Europe.
- Travel expectation: 20-30% per year, both domestic (US) and international.
Essential Duties and Responsibilities: - This individual will work closely with current and potential clients and internal Charles River functional groups to design robust and scientifically sound clinical testing programs. This position will support potential and current clients globally.
- The person may act as the scientific leader for cross-functional teams for integrated testing programs. When appropriate, the individual may perform gap analyses, support due diligence procedures, and perform scientific review of testing data or reports.
- This role provides for recognition throughout the company as a subject matter expert in one or more therapeutic area(s) or class(es) of therapeutic products.
- Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in determining the appropriate analytical strategy for complex and novel products, including advanced medicinal products.
- There will be opportunities to support department leadership regarding strategy and recruitment. More broadly, one will work closely with Business Development, Client Services, Account Management, Marketing, and Operations by ensuring that clients' business and scientific needs are understood and efficiently addressed.
Job QualificationsEducation: Master's degree or PhD in relevant discipline (toxicology, pharmacology, biology, immunology, etc.).
Experience: Minimum 15 years' experience in pharmaceutical/biotech sector, contract research, regulatory or consulting including at least 10 years experience in developing analytical testing protocols.
- Must have direct experience in regulated environments (GLP, GMP).
- Prior experience in program management leadership is preferred.
- Ability to represent Charles River Laboratories at external conferences.
Preferred Qualifications: Certification/Licensure: M.A./M.A./Ph.D. preferred.
Other:
- Applied understanding of regulatory requirements for the conduct of clinical and commercial analytical activities including Testing Facility SOPs and the Good Manufacturing Practices (GMP).
- Deep understanding of relevant regulatory guidance documents is essential.
- Demonstrated leadership skills in support of intra- and interdepartmental initiatives, client/external interactions, and business development.
- Strong presentation skills to technical and non-technical audiences strongly preferred. Ability to present to executive leadership as well as Board of Director audiences.
- Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and standard laboratory calculations.
Compensation DataThe hiring range for this position in the US is $220,000/yr - $250,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, location and any collective agreements, if applicable.
Physical RequirementsAbout Biologics Testing SolutionsWith more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
