Product Development Formulation Scientist III

Research & Development Philadelphia, Pennsylvania


Description

Product Development Senior Formulation Scientist

Job Summary

The Formulation Scientist III is responsible to develop products with minimal supervision-as required that meet the current US FDA Chemistry Manufacturing and Controls (CMC) requirements. The primary focus will be on the development of liquid and solid IR formulations suitable for oral and nasal administration. The products are submitted for registration as part of Abbreviated New Drug Applications (ANDA). This position is responsible for leading product development projects including design, execution, documentation, collaboration, and any additional tasks of a wide range of studies using Quality by Design (QbD) principles and methodologies.

Job Responsibilities

  • Characterizes RLD, API, excipient, packaging materials, and finished product using relevant pre-formulation instrument/techniques independently.
  • Prepare batch record, ensure accuracy of batch record, and execute batch or supervise batch execution accordingly independently.
  • Designs DOE batches and executes experiments to obtain required data to ensure robustness of finished product and critical quality attribute risks are minimized with minimum supervision-as required.
  • Ensures batch manufacturing is completed correctly and efficiently according to batch records including in-process testing and documentation.
  • Review technical package for polymorph & PSD to select API with minimum supervision-as required.
  • Calculate API requirement for the assigned projects with minimum supervision-as required.
  • Searches literature and utilizes all available information to generate a Product summary independently.
  • Searches literature and utilizes all available information to prepare formulation strategies, generate a trade dress and Quality Target Product Profile, and determines Critical Quality Attributes with minimum to no supervision.
  • Prepare drug substance, drug product, and process risk assessment with minimum to no supervision.
  • Review and sign capsules art work and packaging materials COC with minimum to no supervision.
  • Review technical package for polymorph & PSD to select API with minimum supervision-as required.
  • Calculate API requirement for the assigned projects with minimum supervision-as required.
  • Searches literature and utilizes all available information to generate a Product summary independently.
  • Searches literature and utilizes all available information to prepare formulation strategies, generate a trade dress and Quality Target Product Profile, and determines Critical Quality Attributes with minimum to no supervision.
  • Prepare drug substance, drug product, and process risk assessment with minimum to no supervision.
  • Review and sign capsules art work and packaging materials COC with minimum to no supervision.
  • With minimum to no supervision performs IID limit calculation and confirm with RA.
  • Compiles and analyzes data to understand path forward for development work independently.
  • Performs root cause analysis for dissolution/stability issues through literature search with minimum to no supervision.
  • Performs root-cause analysis for development, technology transfer, and submission batches process related issues with minimum to no supervision.
  • Maintains lab notebook accurately in compliance with SOP’s
  • Prepare study design for excipient compatibility/pH challenge/preservatives challenge/antioxidant studies with minimum supervision-as required.
  • Prepare CPR document and re-test memo for BE study with minimum to no supervision.
  • Review Technology transfer and submission batch record, protocol, and report with minimum to no supervision.
  • Compiles and reviews Technology transfer and submission batch data with minimum to no supervision.
  • Prepares and presents technical presentations to management independently.
  • Prepares Modules, Pharmaceutical Development Reports, and QOS and additional reports required for FDA filings with minimum supervision.
  • Prepares FDA deficiency latter response with min supervision-as required.
  • Follows company policies, DEA regulations, and SOP’s.
  • Perform reconciliation of DEA materials with minimum supervision.
  • Wears appropriate personal protective equipment and follows all safety regulations and procedures.
  • Follow up with supply chain for API technical package& ARD for API technical package review.
  • Utilize SAP system to check availability of materials and to create PR for RLD/API/Excipient/Packaging/tablet tools independently.
  • Ensures materials and equipment/equipment parts are available in timely fashion for development work.
  • Request EHS to provide product specific safety requirement for PD and Review MSDS independently.
  • Corresponds with RA to send FDA CC for IID limit, Q1/Q2 with minimum to no supervision.
  • Coordinates development activities with Analytical and Tech Services.
  • Coordinate toxicity report activities independently.
  • Support Technology transfer and submission batch execution.
  • Participates as a member of a multi-functional project team and provide project update with minimum supervision.

 

 

 

Education/Qualifications

  • Bachelor’s degree in pharmaceutical science or chemistry or engineering or related scientific discipline or *Master's degree (M. A.) or *Doctoral degree (Ph. D., etc.) or equivalent
  • 7+ years with BS
  • 3-5+ years with MS
  • 0-2+ years with PhD
  • Competency with MS Word and Excel.
  • Proficient in relevant software (MS office) and statistical software for DOE and data analysis.
  • Capable to manage multiple projects with min supervision-as required.
  • Capable of multi-tasking and adjusting priorities in response to changing conditions and schedules.
  • Working knowledge of equipment utilized in dosage form development -Solid Oral Dosage (Blenders, Granulators, Fluid Beds including Wurster coating, Compression Machines, Encapsulator, Mills, Coater, and any additional equipment for unit operations for Solid Oral product development)- Liquid/Suspension/Nasal Spray (tanks, mixers, homogenizers, filtration assembly, bottle filling, and any additional equipment for unit operations for Liquid/Suspension/Nasal Spray product development.
  • Must be willing to perform hands on work with process equipment as required and flexible to support extended hours, non-standard shift, and manage changes.
  • Establishes and maintains cooperative working relationships with others.
  • Works independently as well as in a group.
  • Impeccable documentation skills.
  • Detailed oriented with the ability to integrate information.
  • Is motivated to do what is expected, a self-starter who makes things happen.
  • Is passionate about work, efficient, and effective in getting the work completed.
  • Proactive, plans ahead, anticipates challenges, accomplishes what is expected and adds value to the job.
  • Familiar with USP to check product specification requirement.
  • Familiar with FDA dissolution guidance/product specific BE guidance/SUPAC guidance/Tablet size and shape guidance/Tablet scoring guidance.
  • Ability to lift equipment or materials weighing up to 25 pounds.