Formulation Scientist

Description:

The holder of the position will be responsible for the formulation development of oral drug delivery products. The Scientist will work with the formulations group on multiple projects for internal and external clients and is expected to drive technical innovation in formulation development. Prior experience with transdermal products and/or oral film products is strongly preferred. Knowledge of chemistry, biochemistry, instrumentation and analytical methodologies is required. Experience in drug product manufacturing and technical transfer of drug product processes is preferred. Strong verbal communication and writing skills will be used to interface with representative, internal and external customers.

Essential Duties:

• Responsible for formulation and process development of oral immediate-release dosage forms, including oral film formulations. Troubleshoot and problem-solve unresolved or new formula issues.
• Design and execute formulation trials, analytical testing and evaluate stability data to finalize formulation composition.
• Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
• Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.
• Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, QbR etc.
• Coordinate sourcing of APIs, excipients, packaging components for new products to meet regulatory requirements.
• Make scientific presentations to internal and external teams as well as external industry meetings
• Prepare/review specifications for drug products and packaging components, etc.
• Coordinate the manufacturing of exhibit/submission batches per regulatory requirements
• Participate to technology transfer for manufacturing processes from laboratory scale to production scale.
• Provide technical support during process validation and cleaning validation studies.
• Coordinate with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA.
• Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGLPs.
• Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality.
• Actively participate in obtaining patents for products, processes, or equipment.
• Communicate with outside vendors and laboratories.
• Provide technical assistance/support for other departments as needed.
• Communicate essential information to the employees within the department and/or within the company.

Qualifications / Skills Required

Min. 3 years work experience is preferred. Recent experience in the pharmaceuticals industry is strongly preferred

Preference will be given to people who have recent experience in Pharmaceutical R&D with focus on drug delivery

Requirements:

• Bachelor or Master degree with a focus in Chemistry, Medicinal Chemistry, Pharmacy or Biochemistry
• Thorough knowledge of the pharmaceutical industry, particularly drug delivery industry, and formulation and process development.
• Knowledge of GMP regulations.
• Skills building and maintaining productive relationships with organizational partners including team work
• Excellent communication and writing skills

Pay: $45,000.00-$75,000.00 per year

Benefits:

• Casual dress
• Dental care
• Extended health care
• Flexible schedule
• Life insurance
• On-site parking

Work Location: In person