This position is responsible for planning and execution of formulation development strategies under supervision. Prepares reports and documents for ANDA submission. The person functions as a subject matter expert in dealing with government agencies.Essential Functions and Responsibilities
Designs and conducts pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects
Plans and executes strategies for formulation development under supervision
Conducts literature search for the projects including publications, patents, etc.
Reviews analytical results, specifications, and solves problems
Prepares reports/documents such as product development reports, quality overall summary, master formulas and other key reports/ documents
Organizes materials and equipment for the execution of batches, and recommends options for procuring
Coordinates with other Actavis development and manufacturing sites
Represents Formulation Development and acts as subject matter expert with government agencies, e.g. FDA during PAI or in responding to deficiencies to submitted ANDA applications.
Presents progress of the projects to the senior management
Functions as per the instructions of the team leader
Guides Technicians on running small-scale R&D batches
Ph.D. in Pharmaceutical Sciences, Chemistry or equivalent with 2 - 4 years of pharmaceutical industry experience in formulation development, process development and/or manufacturing.
M.S. in Pharmaceutical Sciences, Chemistry or equivalent with 2 - 6 years of pharmaceutical industry experience in formulation development, process development and/or manufacturing.
B.S. in Pharmaceutical Sciences, Chemistry or equivalent with 6 – 9 years of pharmaceutical industry experience in formulation development, process development and/or manufacturing.Specialized Knowledge and Skills
Minimum Technical Knowledge and Skills
Thorough understanding of pharmaceutical dosage forms including controlled release drug delivery technologies
Thorough knowledge of Good Manufacturing Practices
Knowledge of FDA regulatory guidance's, ICH guidelines and requirements of ANDA submissions
Working knowledge of patents, pharmacokinetics and biopharmaceutics
Working knowledge of Microsoft suite of software products including Excel, Word and PowerPoint
Minimum Non-Technical Skills and Competencies
Strong oral and written communication skills
Strong organizational skills with the ability to multi-task and prioritize assignments
Ability and willingness to work in a cross-functional team environment
Self motivated with the ability to work under pressure to meet deadlines
Equipment and Applications
Work Environment and Physical Demands
Able to travel as needed
Able to perform laboratory function associated with position and required in a research lab
Standing to perform bench tests, bending, lifting up to 40 lbs., and ability to wear all required safety equipment such as safety glasses, mask, gloves, lab coat as work and environment required