Lupin Pharmaceuticals (Company Headquarters)

Senior Formulations Scientist, Topical Products

2 weeks ago
ID
2017-2193
# of Openings
1
Category
Specialty Product Development

Overview

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 format. Dosage forms include the following: liquid, suspension, emulsion, lotion, gel, ointment, cream, paste.

Responsibilities

  • 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

Any additional project or work assigned from time to time

Qualifications

  • 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 topicals and/or dermatology products
  • 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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