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. PDS is seeking a Scientist with experience in Molecular Biology to join our team. The successful candidate is able to apply prior experience and knowledge to successfully perform in a laboratory environment under regulated conditions.

Essential Position Responsibilities:

• Proficiently perform Molecular biology techniques such as purification of nucleic acids and quantitation assays (e.g. qPCR or ddPCR) 
• Proficiently performs Cell biology techniques applying acceptable aseptic technique.
• Able to qualify and proficiently perform Ligand-binding assays (e.g. ELISA / MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies is a plus.
• Independently performs service tasks as directed.
• Independently performs analysis for validation and sample testing in support of GLP studies.
• Assists with method transfer, development, and troubleshooting in support of GLP studies.
• Responsible for data interpretation and provide data summaries for studies.
• Performs study activities to meet the regulatory, GLP, protocol, and SOP requirements.
• Maintains the experimental records and raw data in a secure way to protect the integrity of the data.
• Reviews and checks data generated by other staff as assigned.
• May represent group in cross departmental initiatives.
• Works safely with potentially hazardous substances, exercise universal precautions.
• Functions effectively in a team-oriented atmosphere and work independently when necessary.
• Knowledge of Watson LIMS and cell culture techniques a plus.
• Capable of navigating and updating electronic inventory systems.
• Maintains a clean lab and work environment.
• Perform other duties as assigned.

Additional Position Requirements:

• May perform operational duties in areas of appropriate experience and training.
• Mentoring and training junior staff
• Become a Subject Matter Expert on process or equipment
• Must be able to lift 40 pounds.

Additional Requirements:

• Perform general laboratory support functions such as supply inventory, shipping procedures, or data maintenance.
• 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 of time, including working within a laboratory hood and at standing bench top.
• Repetitive work with hands.

Qualifications:

• BA/BS in Biological or Physical Sciences and at least 2 - 3 years of relevant experience, MS in relevant field and at least 1-2 years of relevant experience.
• Level of position will be commensurate with 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.

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