Senior Manager/Director, Analytical Research & Development

Hi-Tech Pharmacal is a developer and manufacturer of generic and branded pharmaceutical products. Hi-Tech is a small dymanic company focused on RX liquid and semi-solid formulations, as well as sterile ophthalmic and nasal products.

The Company is looking for a Senior Manager/Director to lead its Analytical R&D Group. Successful candidate will have the following resposibilities:

Manage a group of 8-12 analytical chemists to develop analytical methods for drug substances, preservatives and degradation/impurities in new productsDesign and supervise the execution of validation experiments using HPLC, GC, UV/VIS, etc. in accordance with current FDA regulations, ICH guidelines, USP test methodologies, cGLPs and Hi-Tech SOPsDesign and execute cleaning validation studiesSupervise the in-process, finished product/release and stability testing of dosage forms as per the approved methods.Assure that all method development, validation and testing activities are documented as per cGLPs.Provide analytical support to formulation group in order to finalize the formulation composition for new productsSupervise analytical method transfers from R&D to QC laboratory and from vendor to R&D8.  Write/review analytical methods, method validation protocols, method validation reports, method transfer protocols/reports, stability summary reports etc.

Education/Experience requirements:

MS/Ph.D in Analytical Chemistry or related discipline with 5-8 years of experience in pharmaceutical environment (preferably in generic industry)2-5 years of supervisory experience in analytical laboratory setting is a must.Strong hands-on instrumentation experience using analytical techniques such as HPLC, GC etc.  A sound knowledge of separation and spectroscopic sciences and thorough understanding of FDA regulations are essential. Strong people and organizational skills
The company offers the following Benefits Package:

Solid base salary and bonus
Participation in Company's Incentive Stock Option Plan
Participation in 401 K Plan