Ar&D Group Lead

PRIMARY PURPOSE:

Ensure all analytical development work is scheduled and executed as per defined project timelines. The AR&D Group Leader will act as the primary scheduler of analytical development work conducted by AR&D Team. The AR&D Group Leader will work closely with the AR&D Laboratory Manager to communicate project status and work collaboratively to address technical issues associated with AR&D work.

MAJOR DUTIES AND RESPONSIBILITIES:

• Schedule and supervise daily work for the AR&D group in the AR&D Lab.

• Provide clear visibility to all appropriate personal as to project status, investigations, or development issues.

• Collaborate with AR&D management for laboratory investigations, as required.

• Collaborate with QC staff in scheduling of personnel and equipment.

• Attend project team meetings as needed.

• Perform all of the activities for transferring and validating analytical methods.

• Revise and write Test Methods, IRs, PTS, and SOPs as needed

• Write and review method transfer/validation protocols and reports

• Interface with I&D Formulators to support testing for new product development

• Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP and other approved test methods.

• Maintain analytical reagents in AR&D laboratory including but not limited to: inventory, current MSDS, PPE required for handling, waste generation and disposal.

• Assist Validation teams in cleaning validation activities.

• Promote GMP and safety throughout the facility.

• Promote continuous improvement and customer satisfaction.

• Follow-up on OOS's and CAPAs to verify compliance.

• Potential exists for exposure to potentially harmful chemicals.

• Participate in other activities as assigned by the AR&D Lab Manager and CSO

QUALIFICATIONS:

Required

• Knowledge of Compendia testing.

• Working knowledge of FDA regulation for drug/device especially for the lab.

• Ability to use a personal computer and peripheral equipment to accurately enter an analyze data and produce reports.

• Knowledge of chemical safety and protective equipment.

• Knowledge of various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, infrared spectrum, HPLC, GC, atomic absorption.

• Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.

• Ability to handle and resolve recurring problems.

• Communicate with others clearly and concisely.

• Ability to work in a dynamic fast paced environment-sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.

• Must be able to lift up to 15 pounds.

EDUCATION AND TRAINING

• Bachelor's degree in Chemistry or appropriate discipline.

• Must have four to five years experience working in an analytical laboratory in an FDA regulated industry.