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Sr. Formulations Scientist, Nasal Spray

Lupin


Location:
Somerset, New Jersey 08873
Date:
11/15/2017
2017-11-152017-12-15
Job Type:
Employee
Job Status:
Full Time
Lupin
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Job Details

Perform formulation development and scale-up processes in support of ANDA submission batches in a regulated manufacturing environment. Analyze and interpret results in written and oral formats. Dosage forms include the following: nasal sprays (both suspension and solution), sub-lingual sprays.

  • Develop new delivery technologies and incorporating existing or emerging technologies in the development of proprietary products
  • Lead development efforts of complex generic products and development of new proprietary formulations
  • Develop pharmaceutical formulations utilizing Quality by Design (QbD) and risk assessment concepts
  • Support process development and manufacturing when required
  • Work closely with patent attorneys to establish and protect intellectual property
  • Review work done by junior scientist as it relates to R&D projects, to ensure accuracy and flawless product development
  • Write/review technical documents supporting INDs/NDAs/ANDAs that also may include papers for publications regarding new or emerging drug delivery systems
  • Provide technical expertise in intellectual property strategies
  • Work closely with all departments (Analytical, Product Development, Quality Control, Quality Assurance, Regulatory, and Manufacturing) to achieve project goals in a fast-paced environment
  • Maintain accurate lab notebooks and complete all related development reports, in compliance with SOPs
  • Ensure equipment and materials are available in a timely fashion for submission batches and to coordinate with manufacturing department as needed

Requirements

  • B.S., 10-15 years' experience; or M.S., 5-10 years' experience, or PhD, 1-5 years' experience, with focus in chemistry, biology or pharmaceutics
  • Experience in product development of nasal spray/sub-lingual spray
  • Experience in devices used for nasal spray/sub-lingual spray products
  • Experience in the use of analytical equipment used for spray characterization (e.g., spray pattern, plume geometry, droplet size, drug in small particles, etc. using SprayView® Spraytec®, Andersen Cascade Impactor).
  • Subject matter expert for CMC-related activities, including formulation development, process development, container / closure.
  • Pilot plant manufacturing experience.
  • Experience in project management as either project leader or functional lead to project team
  • Skilled in drug delivery optimization, using DOE where applicable
  • Experience with regulatory requirements for ANDAs.
  • Experience with eCTD format for regulatory filings
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