Associate Scientist

About the role

Smithers PDS LLC (Pharmaceutical Development Services) assists in the development of new medicines by providing bioanalytical services for all phases of drug development from discovery through approval and post-market surveillance. 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 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.

This position is classified as exempt and paid on a salary basis. 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.

Responsibilities

• Perform data entry and written documentation with supervision.
• Preparation of reagents and standards with supervision.
• Perform service tasks as directed.
• With supervision, assist with data interpretation and provide data summaries for studies.
• Perform study activities to meet the regulatory, GLP, protocol, and SOP requirements.
• With supervision, ensure the experimental records and raw data are stored securely to protect data integrity.
• Order supplies and other materials necessary for the conduct of studies.
• Work safely with potentially hazardous substances, exercise universal precautions.
• Function effectively in a team-oriented atmosphere and work independently when necessary.
• Capable of learning new systems such as Watson LIMS and cell culture techniques (a plus).
• Navigate and update electronic inventory systems.
• Other duties as assigned.

Additional Responsibilities

• Perform general laboratory support functions, including shipping procedures, receiving, checking-in, and disposing of study samples according to established guidelines and SOPs.
• Complete all assigned tasks with appropriate paperwork in a timely fashion.
• Sample management functions, including:
  • Identify and document all discrepancies between client paperwork, Watson LIMS, and sample vials.
  • Notify sponsor, Project Team, and PI/PM of discrepancies.
• Must be able to lift 40 pounds.

Requirements

• BA/BS in Biological or Physical Sciences or AA with at least 6 months to 1 year of relevant experience.
• Knowledge of GLP regulations and other regulatory guidelines.
• Excellent communication skills, both oral and written, and strong organizational skills.
• Proficient in the use of basic computer applications such as MS Word and Excel.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Additional Requirements

• Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.
• Overtime, weekend, and holiday work as required.
• Effective written and oral communication skills.
• Work requires some standing and sitting for long periods, including working within a laboratory hood and at a standing bench top.
• Intricate work with hands.

Corporate Responsibilities

• Adherence to laboratory health and safety procedures.
• Adherence to Standard Operating Procedures (SOPs) and applicable company policies/guidelines.
• Adherence to federal and/or local regulations, as applicable.

Pay

The annualized salary range for an Associate Scientist position is $60,000 - $70,000. Experience and qualifications will determine salary and job level.

Benefits

• Comprehensive health insurance package including a choice of 3 medical plans.
• Dental insurance.
• Vision insurance.
• 401K retirement plan.
• Paid time off (PTO).