Quality Control Chemistry Manager / Associate Director
Summit Biosciences Inc. - Lexington, KY

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Summary:

Reporting to executive management, the incumbant is responsible for the overall operations of the Quality Control Chemistry laboratory including assisting with or leading projects related to the development and commercialization of multiple nasal spray drug products. This position is responsible for implementing and managing cGMP compliant practices in the laboratory environment and also for managing raw material and component testing, analytical methods transfer, and in-process and finished product release and stability testing.

Essential Duties:
Manage the day-to-day operations of the QC Chemistry laboratory in a high-growth, fast-paced, dynamic work environment.
Assist with method development, assay validation and characterization for multiple drug substances and drug products.
Manage in-vitro bioequivalence studies for various nasal spray drug products.
Identify, evaluate and purchase analytical and laboratory support equipment.
Write SOPs, programs, specifications and protocols necessary for laboratory operations.
Lead validation activiites related to laboratory instrumentation and contribute as a member to the manufacturing plant validation team.
Manage the laboratory in compliance with FDA, OSHA and DEA regulations.
Write technical reports and assist with formulation development studies.
Direct, perform and resolve out-of-specification investigations and implement corrective and preventative actions.
Recruit, train and manage one or more direct reports.
Assist with the development and management of the QC Microbiology laboratory.
Assist with DEA control and reporting activities.
Manage internal and external projects related to drug development, providing contract services to clients and other miscellaneous projects.
Develop budgets for the laboratory.

Preferred Knowledge, Skills and Abilities:
Ability to plan and manage well in order to deliver high quality results on time.
Extensive technical experience in analysis and development of pharmaceuticals.
Comprehensive understanding of small molecule chemistry.
Demonstrated knowledge of modern analytical techniques, including HPLC. Knowledge of nasal spray characterization is a plus.
Experience in development and validation of methods destined for QC in the pharmaceutical industry
Understanding of current Good Manufacturing Practices (cGMPs).
Proven team player with well-developed interpersonal organizational and communication skills, including written documentation and presentation skills.
Interest in learning and applying new technologies.
Ability to change priorities in response to company demands while continuing to deliver results.

Requirements
BS in Chemistry, Biochemistry or related field.
12 years of applicable experience in a pharmaceutical laboratory with at least 5 years in a leadership position.
Hands on experience with analytical methods development and validation for small molecules.
Experience developing specifications for raw materials and finished product.
In depth knowledge of cGMP and ICH regulatory requirements.
Exceptional expertise and know-how with all laboratory equipment in order to train staff and troubleshoot issues when needed
Excellent technical writing, project management and exceptional organizational skills
Good interpersonal skills and the ability to work well in a team environment
Enthusiasm for building a company with outstanding work ethic; must be able to perform in a fast paced multiproduct environment
Able to shift the priorities of the team quickly while continuing to deliver exceptional work quality
Enthusiasm for working in teams and collaborating with both internal and external colleagues
Formulation development experience is a plus.
Proven ability to train staff on complex analytical equipment and processes.
Qualified to handle controlled substances.

How to apply:

Please submit resume and cover letter.

For additional opportunities, see our career center at www.summitbiosciences.com


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