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.
Smithers is seeking a talented Associate Research Scientist with expertise in bioanalytical assays (PK, ADA, Nab). 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.
The salary range for the role is $75,000 - $100,000 per year commensurate with experience and qualifications. Smithers PDS has a comprehensive health insurance package including a choice of 3 medical plans, dental, vision, 401K retirement plan and PTO.
- BA/BS in Biological or Physical Sciences and at least 3 - 5 years of relevant experience, MS in relevant field and at least 1-2 years of experience
- Understanding of bioanalytical assays (various design and platforms)
- Experience supporting method 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
- 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
- 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
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Skills Required
- BA/BS in Biological or Physical Sciences with 3-5 years relevant experience, or MS in relevant field with 1-2 years experience
- Understanding of bioanalytical assays (PK, ADA, Nab) and various platforms
- Experience supporting method validation studies
- Experience with assay troubleshooting
- Ability to train and provide technical guidance to junior scientists
- Proficient in MS Word, Excel, statistical programs, and Watson LIMS database
- Adherence to GLP, GCP, CLIA and laboratory SOPs and safety procedures
- Prior CRO experience
- Experience with automated laboratory systems
- Experience drafting Standard Operating Procedures (SOPs)
- Excellent oral and written communication skills and ability to work independently and in teams
What We Do
Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA. Our experienced medical device and extractables and leachables (E&L) testing teams will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO. Smithers also supports the pharmaceutical industry and the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high sensitivity assays. Our scientists have expertise in large molecule bioanalysis assay development, validation, and sample analysis.
