The opportunity
Actavis Laboratories FL, Inc. is seeking a Scientist III (Weston, FL) to carry out the design and development of solid oral dosage forms using quality by design (QbD concept) through ANDA filing and / or product launch.
Design experimental plan and perform pre-formulation and formulation development work on Oral Controlled release and immediate release dosage forms.
Generate and review analytical data to support the product development work. Identify, review, and select the appropriate API and other specialized raw materials required for use in new product development.
Prepare pharmaceutical product development report (PDR), Quality overall Summary (QOS), and other necessary documents to support regulatory filing of ANDA’s.
Survey the scientific literature and perform patent search to remain current with recent developments in generic pharmaceutical research and regulatory arena and novel drug delivery systems.
Plan bioequivalence studies on drug product and evaluate the bioequivalence data to recommend changes in formulation. Maintain appropriate documentation of primary data records, report sheets, and laboratory notebooks as required by Standard Operating Procedures.
10% domestic travel and 10% international travel required.
Your experience and qualifications
Requires a Master’s degree in Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences, Pharmaceutics, or a related field and 7 years of product development of oral solid dosage forms and formulation & process development through ANDA submission experience.
Must have experience with :
- Handling and trouble-shooting all major manufacturing processes / equipment that are used in formulation development including blending, tableting, wurster coating, extrusion / spehronization, and hot melt extrusion;
- Regulatory requirements needed for product development process including guidance from various regulatory agencies, compendia requirements, and cGMP requirements;
- ANDA filing procedures and necessary requirements needed as part of the regulatory documentation needed for the submission of various projects to various regulatory agencies;
- Preparing various scientific documents needed as part of the development and submission; Handling queries from the regulatory agencies;
- BA / BE studies that are performed on human volunteers; and Correlation of the data generated during the development in labs and its interpretation from BA / BE perspective.
10% domestic travel and 10% international travel required.
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM.
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