Neos Therapeutics® is a privately owned drug delivery and full service contract manufacturing company serving prescription pharmaceutical and consumer healthcare markets. Neos’ proprietary drug delivery technology platform is clinically proven. Our operating model is to develop prescription and OTC products working in partnership with healthcare companies. The Neos technology enables creation of innovative dosage forms, notably controlled release (CR) liquids and CR orally disintegrating tablets (ODTs). Our expertise, technology and full service contract manufacturing spans the range of oral drug dosage forms from conventional tablets and capsules to the truly unique CR liquids and CR ODTs.
The Laboratory Manager plans and implements the laboratory policies, procedures, and services for the Quality Control Laboratory. Ensures efficient and effective departmental operations, including department quality control and regulatory compliance adherence.
Essential Job Functions
Manage all QC sampling schedules and testing; ensure data and lab reports are being generated from the lab in a timely, accurate and methodical manner.
Schedule and oversee all QC laboratory operations and testing to approve/release all finished product, intermediates, stability and raw materials tested in the laboratory.
Ensure raw material, in-process, bulk product, and finished product testing is scheduled efficiently and in support of production scheduling.
Assess suitability of new/proposed methods for routine QC application and investigate opportunities for QC improvements prior to product launch
Coordinate the stability program, including sample procurement, testing, protocol/report writing and approval, database management, inventory control, and statistical projections.
Ensure laboratory cGMP compliance with FDA regulations.
Responsible for the timely hiring, training and development of qualified staff to ensure effective testing, execution of roles and responsibilities, GMP compliance, and attainment of operational and development goals. Maintain daily staffing requirements to meet business needs. Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective lab operation that supports business needs.
Knowledge and Skills Required
Bachelor’s degree in science-related field. Masters Degree Preferred.
7+ years of pharmaceutical laboratory experience.
7+ years experience supervising and managing others.
Proficient with HPLC, GC, FT-IR, particle site analysis, and numerous other pieces of analytical equipment.
Technical writing experience.