Associate Scientist, QC Client Services

Position Summary

The Associate Scientist, QC Client Services will provide technical knowledge to clients in a defined area of expertise. Expertise will include fundamental knowledge in technical transfer and data integrity evaluation in relation to Quality Control (Microbiological and Analytical) testing. The Associate Scientist will also author technical documents with Quality Assurance (QA) oversight. Additionally, the role will involve client interfacing, testing of samples, data review, and support of key business non-testing activities including client support, in accordance with cGMP regulations and departmental procedures.

Duties & Responsibilities

• Author technical documentation to completion.
• Assisting Quality in completing new technical method qualifications and modalities.
• Assisting Quality in completing data integrity assessments for new instrumentation and modalities.
• Provide client facing support for existing and potential clients.
• Perform sample testing and data review.
• Applied knowledge and in-depth understanding of microbiological and analytical techniques.
• Demonstrated proficiency and ability to work independently.
• Assist with scientific insight for laboratory investigations, determine root cause for laboratory errors, and identify appropriate corrective/preventive actions for laboratory errors.
• Accurately document laboratory work.
• Be knowledgeable of current regulations pertaining to area of expertise.
• Assist with scientific insight for trends or results.
• Assist with scientific insight in determination of instrument performance checks/calibrations and participate in new instrument qualifications.
• Assist with scientific oversight of troubleshooting of instrumentation and methods. Recognize instrumentation and method issues and provide recommendations to management to resolve them.
• Provide scientific review during revision of SOPs as required.
• Seek to improve/obtain new technical skills and share learnings with department.
• Participate in filing review activities for area of expertise.
• Maintain and promote a safe working environment.

Education & Experience

B.A or B.S. degree in Biological Sciences or related field with greater than 3 years of cGMP laboratory experience and/or relevant biopharmaceutical industry experience.

Knowledge, Skills, Abilities

• Demonstrated expert level theoretical and technical knowledge in area of concentration; skills, hands on training, and cGMP experience within the laboratory setting are required.
• Instrumentation experience in area of concentration.
• Familiarity with pharmaceutical regulations and general compendia (USP/EP/JP) methodology and instrumentation requirements are required.
• The candidate should be self-directed with a high degree of professional integrity, be organized, and detail oriented.
• Demonstrated problem solving ability and effective technical trouble shooting is required.
• Interpersonal, oral and written communication skills required.
• Demonstrated ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail and to contribute to a team based, collaborative, and positive environment ensuring clarity of purpose and high commitment to business goals.
• Demonstrated ability to work independently and in a team setting.

Physical Demands

Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on stepstools, and reaching is required. This role also requires frequent unassisted lifting (not to exceed 50 lbs.). Repetitive use of arms/hands/wrists and grasping is also required.

Work Environment

This position is office and laboratory based and requires the use of appropriate levels of personal protective equipment (PPE). This role will require safe interaction with biohazardous materials. Powdered materials and high temperature liquids and solids are also handled. This position is based indoors and primarily involves working with others, but also independently at times. This position is a team-based position that may require shift work, weekends, and holidays.

Travel

Less than 5% travel is required for this position. 

Target Bonus

8%

Work Location:

East Syracuse, NY