Formulation Scientist II

Organization
Actavis, Inc.
Job Location
Elizabeth, NJ
Job Description

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

Requirements: 

Education/Training/Work Experience 
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 

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