Senior Formulations Scientist Job at Mallinckrodt

Mallinckrodt St. Louis, MO

Job Title
Senior Formulations Scientist
Requisition
JR000013167 Senior Formulations Scientist (Open)
Location
Webster Groves (Pharma) - USA038
Additional Locations
St. Louis, MO
Job Description
Mallinckrodt Pharmaceuticals is seeking a highly motivated candidate as a Sr. Formulations Scientists in generic dosage product development Research & Development. The successful candidate for the position will be the primary technical member of all formulation development activities including the analysis of innovator’s patents, planning and execution of the formulation and process development, tech transfer, scale up, manufacture of registration batches, creation of product development report and CMC documents for submission, and pre- and validation support at a commercial manufacturing site. The candidate will serve as a key driver to identify, analyze, suggest and own improvement actions to build a high performance organization.
ESSENTIAL FUNCTIONS:
  • Executes assigned projects and activities; develops detailed planning of the formulation and process, scale-up activities, registration batch manufacturing and pre- and validation support at a commercial manufacturing site.
  • Conceives and develops novel, innovative drug delivery systems to enrich product the pipeline.
  • Generates and/or reviews scientific documents including protocols, summary reports, tech transfer reports, and other relevant scientific information packages for internal and external use.
  • Assists the Regulatory Affairs group in preparation of CMC documents for the submission of ANDAs including the product development report (PDR).
  • Provides troubleshooting at scale-up/commercial level.
  • Other duties as assigned.
MINIMUM REQUIREMENTS:
Education /Experience:
  • PhD. in pharmaceutical sciences or related science field with minimum of 0-1 years of related experience or MS degree with minimum of 4 years of related experience or BS with minimum of 7 years of related experience required.
  • Hands-on experience in formulation for oral solid and liquid pharmaceutical dosage forms required.
  • Experience supervising, leading and training scientist and other laboratory personnel preferred.

Skills/Qualifications:
  • Strong knowledge in pharmaceutical dosage products (e.g., both oral liquid and solid dosage forms) and drug delivery concepts for various administration routes.
  • Working knowledge of evaluating patents and literature prior arts.
  • General knowledge of pharmaceutical analytical techniques
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
  • This position reports to the Executive Director Formulations
  • Partners closely with marketing, regulatory affairs, legal, project managers, and manufacturing
WORKING CONDITIONS:
  • Typical laboratory environment
  • Ability to travel 10 – 30%
  • Must pass a security clearance
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