Carries out responsibilities in compliance with all cGMP, Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Safety and Health Administration (OSHA)
Efficiently executes product development activities, including pre-formulation, formulation and process development studies with good scientific standards, under the guidance of senior staff.
Coordinates sample testing with analytical teams and performs characterization as required.
Supports manufacture of GMP pilot and pivotal batches, including drafting of protocols and batch records and reports.
Creates and revises Standard Operating Procedures (SOPs) as needed.
Supports investigations, Corrective Action Preventive Actions (CAPAs) and change controls as required.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
MS or BS degree and minimum 2 – 5 years experience in a product development or formulation laboratory in pharmaceutical, biotechnology or related academic research environment
732-661-0400
info@astrixinc.com