Lead Chemist - Method Development / Validation

LEINER HEALTH PRODUCTSWe’re growing and looking for world-class team members.At Leiner Health Products, we manufacture store brand vitamins, minerals, supplements and over-the-counter drugs for America’s top retailers.
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LEAD CHEMIST – METHODS DEVELOPMENT / VALIDATIONThe Lead Chemist is responsible for New Product Method Development in the OTC /VMS setting.Coordinates and conducts all activities related to developing and validating methods for OTC products and processesLeads the Method Validation group by assigning tasks, and supports the generation of specifications for new OTC products
Performs reviews of SAF samples to approve new vendors and itemsWrites, reviews and approves Method Validation Protocols and Reports
Interfaces with contract customers regarding their requirements for Method Validation
Secures approvals from contract manufacturing customers on Protocols and Final ReportsRepresents Method Validation function during customer and regulatory audits
Develops and validates new OTC and/or VMS methods from product profiles provided by Marketing, Technical Operations, and R & D
Directs resources to accomplish group requirements, and assures completion of corporate project timelines
Through research, remains current with developments and trends in area of expertise REQUIREMENTS
EDUCATION
Bachelor’s Degree in Chemistry, Life Science, or equivalent.
EXPERIENCE
Seven years of lab experience (QA/QC).Three years experience in Method Development for a OTC/Pharmaceutical company.
SKILLSProficiency in analytical instrumentation (HPLC, GC, FT-IR, UV-Vis, etc.) processes
cGMP, OSHA, FDA, and related policies
Advanced mathematics, including conversions, statistics and percentages
Software applications, MS Office, LIMS, and Millennium/Empower
Problem solving independently and in teams
Effective presentation skills (preparing & developing)
Strong ability to train others
Strong conflict management skillsLeiner Health Products is an Equal Opportunity Employer – EEO/AA/M/F/D/V