For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Basic Summary
We are seeking a Scientist I for our Biologics Testing Solutions site located in Wayne, PA.
Serve as a scientist in the Virology Department performing assigned research duties which may include assay optimization, study development and management, interpretation and reporting of study data, and ensuring the regulatory compliance of these projects. Scientists may also directly supervise employees involved in the research and development of both internal and client-related testing procedures. May supervise a limited number of employees involved in the research and development of both internal and client testing procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES:
- In conjunction with senior scientific staff, function effectively as a principal investigator in the direction and execution of assigned studies.
- Assist in the acquisition, review, interpretation, integration and presentation of study data.
- Initiate and perform assays according to defined protocols.
- Assist in the review of existing procedures to identify areas for process optimization.
- Investigate and develop new methodologies.
- Participate in novel assay design and implementation.
- Research innovative equipment and processes for possible inclusion in existing assays.
- Collaborate with others to coordinate interdepartmental projects.
- Provide technical guidance to laboratory personnel, as needed.
- Advise personnel in the statistical analyses of study data.
- Attend scientific meetings, conferences and training courses to enhance job and professional skills, bringing new insight back to the group to enhance overall departmental knowledge.
- Function as a point of contact for the planning and execution of client related studies.
- Job duties will include:
- proposal management,
- protocol generation,
- study scheduling,
- study performance and reporting.
- Recommend short-range operating objectives, organizational structure, staffing requirements and succession plans.
- As required, oversee maintenance of group training manual and training records.
- Support the policy of equal employment opportunity through affirmative action in personnel actions.
- Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures, and biosafety protocols].
- May be responsible for personnel activities such as:
- personnel actions (interview and selection of hires, promotions, transfers, etc.).
- May assist in training and development, including regular direction, coaching and feedback on performance.
- May assist in preparation and delivery of performance and development plans and salary reviews.
- May partner with Human Resources for disciplinary actions.
- May review and approve recorded working time and vacation/time off schedules.
- May schedule overtime as authorized.
- Perform all other related duties as assigned.
- Ph.D. or advanced degree in a scientific discipline.
- Ph.D. with 0 to 3 years or Masters' degree with 3 to 5 years of related industry experience (pharmaceutical, research laboratory, CRO).
- Working knowledge of the following is preferred:
- Virus propagation and titration;
- plaque and adventitious virus assays;
- statistics as it applies to scientific data evaluation.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Effective written and verbal communication skills.
- Ability to handle multiple projects, prioritize work and meet deadlines.
- Proficiency in the use of standard software including Microsoft® Suite, and with standard laboratory calculations.
- Full understanding of regulatory requirements of study types assigned based on Good Manufacturing Practices (GMPs).
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19. Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.About Biologics Testing Solutions
With 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.