Manager of QC Chemistry

Kindeva is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows.

Summary:

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:

• 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.
• Participate in the validation of the laboratory support equipment and the manufacturing plant systems and processes.
• Manage the laboratory in compliance with FDA, EU, DEA, and OSHA regulations.
• Write technical reports and assist with formulation development studies.
• Direct, perform and resolve out-of-specification investigations and implement corrective and preventive actions.
• Recruit, train and manage one or more direct reports.
• Assist with DEA licensing 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.
• Other duties as assigned.

Preferred Knowledge, Skills and Abilities: 

• 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
• BS in Chemistry, Biochemistry, or related field
• 15 years of applicable experience in a pharmaceutical laboratory
• Hands on experience with analytical methods development and validation for small molecules
• Experience in developing specifications for raw materials and finished product
• In-depth knowledge of cGMP and ICH regulatory requirements
• Ability to manage and develop the laboratory staff
• Excellent technical writing, project management and organizational skills
• Qualified to handle controlled substances
• Good interpersonal skills and the ability to work well in a team environment
• Ability to change priorities in response to company demands while continuing to deliver results
• Enthusiasm for building a company with outstanding work ethic; must be able to perform in a fast-paced multiproduct environment
• Enthusiasm for working in teams and collaborating with both internal and external colleagues
• Formulation development experience is a plus
• Interest in learning and applying new technologies
• Qualified to work with controlled substances