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QC Chemistry Team Lead

Employer
Summit Biosciences Inc.
Location
Lexington, KY
Closing date
Sep 27, 2022

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Summit Biosciences is a fast growing leader in the field of Intranasal Pharmaceuticals. At Summit Biosciences, we aim to provide and promote an environment of continuous learning and improvement, which leads to and harnesses innovation.

We offer fantastic perks & benefits such as strong compensation w/ bonus program, medical/dental/vision/life/disability insurance, 401k + company match, holidays off, PTO, a family like culture, and much more!

The QC Chemistry Team Lead is responsible for managing and coordinating the activities in the Quality Control Chemistry laboratory. The individual will manage all incoming raw material and component testing, contract testing, in-process and finished product testing. The QC Chemistry Team Lead reports to the Manager of Quality Control Chemistry.

Essential Duties:
  • Work in a safe manner in accordance with site procedures.
  • Responsible for the day-to-day QC Chemistry scheduling to meet cycle-times and stability commitments.
  • Responsible for ensuring all QC Chemistry raw material, in process and release/stability testing occurs in a timely and organized manner and in accordance with cGMP and DEA regulations.
  • Advanced cGMPs understanding.
  • Review data and reports to ensure accuracy and compliance to procedures.
  • Oversee and actively participate in investigations, problem solving and troubleshooting.
  • Write, revise and review Standard Operating Procedure, Material Specifications and Forms.
  • Perform data trending analyses.
  • Maintain the laboratory in accordance with SOPs.
  • Proficient with HPLC and GC, ensure analytical instrumentation is maintained and assist in instrument qualification.
  • Participate in DEA licensing and reporting activities.
  • Coordinate projects related to establishing new capabilities and/or drug development programs.
  • Strong oral and written communication skills. Clearly and concisely articulate details in a professional manner.
  • Recommend and implement, as required, innovative approaches to problem solving.
  • Able to manage multiple projects efficiently to meet deadlines.
  • Provide training and assistance to Quality Control Chemistry members.
  • Train and supervise 1 or more direct reports.
  • Other duties as assigned.


Essential, skills and abilities:
  • Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.
  • Team player with well-developed interpersonal, organizational, and communication skills.
  • Maintains proper social etiquette and self-control when dealing with stressful situations.
  • Strong organizational skills.

Qualifications:
  • Bachelor's in Chemistry or related field with at least 10 years pharmaceutical industry experience
  • Master's degree in Chemistry or related field with at least 8 years pharmaceutical industry experience
  • PhD in Chemistry or related field with at least 6 years of pharmaceutical industry experience
  • Qualified to work with controlled substances
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