Associate Research Scientist

Overview

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, and perform the assays necessary to analyze samples from patients on more than 100 clinical trials 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.

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.

• Design, development, and feasibility assessment of new bioanalytical assays (PK, ADA, Nab).
• Perform assay development and validation activities and contribute to feasibility studies.
• Provide assay troubleshooting and technical support to project teams.
• Assist with training and provide technical guidance to junior scientists as needed.
• Collaborate with internal and external teams to meet project deliverables and quality standards.

• BA/BS in Biological or Physical Sciences with 3–5 years of relevant experience; MS in a relevant field with 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.
• Prior CRO and GLP, GCP, and/or CLIA experience is a plus.
• Experience with automated laboratory systems is a plus.
• Experience in drafting SOPs is 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.
• Ensure 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 MS Word, Excel, statistical programs, and Watson LIMS database.
• Able to work independently and manage priorities, as well as operate as a team member.
• Solution oriented and open to input.
• Ability to adapt to a dynamic environment with shifting priorities.
• Ability to collaborate with and partner at all levels of the organization to accomplish deliverables and meet quality standards.