Associate Research Scientist / Research Scientist
Smithers
Summary
Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories.
Job description
Smithers is seeking a talented Associate Research Scientist or Research Scientist with expertise in bioanalytical assays (PK, ADA, Nab). The job level will be commensurate with previously related experience. The individual will be responsible for design, development and feasibility of new assays.
This position is salaried and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments.
Qualifications
- Associate Research Scientist: BA/BS in Biological or Physical Sciences and at least 3 - 5 years of relevant experience; or MS in relevant field and at least 1-2 years of relevant experience
- Research Scientist: BS/BA in biology, life sciences, or chemistry field and at least 5 years’ experience in immunological assay development; or MS in biology, life sciences, or chemistry field and 4 years’ experience in immunological assay development; or PhD in biology, life sciences, or chemistry field and 2 years’ experience in immunological assay development
- Understanding of bioanalytical assays (various design and platforms)
- Experience supporting or leading method development and validation studies
- Experience with assay troubleshooting
- Ability to assist with training and provide technical guidance to more junior scientists as needed
- Prior CRO and GLP, GCP, and/or CLIA experience a plus
- Experience with automated laboratory systems a plus
- Experience in drafting SOPs a plus
Corporate Responsibilities
- Adherence to laboratory health and safety procedures
- Adherence to Standard Operating Procedures (SOPs)
- Adherence to applicable company policies and guidelines
- Adherence to federal and/or local regulations, as applicable
- Ensures appropriate reporting when there is reason to believe compliance with regulations, policies, guidelines, SOPs, quality, or other criteria are not being observed or enforced
- Ensure materials and equipment are maintained
Standard Requirements
- Excellent oral and written communication skills
- Proficient in advanced computer applications including MS Word, Excel, statistical programs, and Watson LIMS database
- Able to work independently and manage priorities, as well as operate as a team member
- Must be solution oriented and open to input
- Must be able to comfortably and successfully operate in a dynamic environment with shifting priorities
- Must be able to collaborate and partner at all levels of the organization to accomplish deliverables and meet quality standards
Requirements
- BA/BS in Biological or Physical Sciences and at least 3 - 5 years of relevant experience; or MS in relevant field and at least 1-2 years of relevant experience
- BS/BA in biology, life sciences, or chemistry field and at least 5 years’ experience in immunological assay development; or MS in biology, life sciences, or chemistry field and 4 years’ experience in immunological assay development; or PhD in biology, life sciences, or chemistry field and 2 years’ experience in immunological assay development
- Understanding of bioanalytical assays (various design and platforms)
- Experience supporting or leading method development and validation studies
- Experience with assay troubleshooting
- Ability to assist with training and provide technical guidance to more junior scientists as needed
- Prior CRO and GLP, GCP, and/or CLIA experience a plus
- Experience with automated laboratory systems a plus
- Experience in drafting SOPs a plus
- Excellent oral and written communication skills
- Proficient in advanced computer applications including MS Word, Excel, statistical programs, and Watson LIMS database
- Able to work independently and manage priorities, as well as operate as a team member
- Must be solution oriented and open to input
- Must be able to comfortably and successfully operate in a dynamic environment with shifting priorities
- Must be able to collaborate and partner at all levels of the organization to accomplish deliverables and meet quality standards
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan
- PTO
Company overview
Founded in 1925 and headquartered in Akron, Ohio, Smithers is a multinational provider of comprehensive testing, consulting, information, and certification services. With world-class laboratories and operations spanning North America, Europe, and Asia, the company serves diverse industries including life sciences, transportation, packaging, materials, components, consumer goods, and energy. Smithers delivers accurate data and regulatory compliance solutions by integrating scientific expertise with advanced technology and business acumen, enabling clients to innovate with confidence. The company's life science division offers specialized pharmaceutical development services, medical device testing, environmental risk assessment, and cannabis testing, supporting clients through all phases of product development and regulatory approval. With a team of 501-1,000 employees including key opinion leaders and scientific experts, Smithers maintains a reputation for delivering precise, timely results that meet stringent FDA, EMA, and ISO standards across multiple regulatory frameworks.