Formulation Engineer

Responsibilities

• Plan formulation DOE and process development trials through development plans.
• Avoids assisting supervisors on sourcing material and equipment.
• Summarizes trial results in technical summary reports.
• Create, revise and approve batch records, work instructions, and other quality system documents.
• Conduct technical investigations of manufacturing and laboratory deviations.
• Use various lab physical and chemical characterization equipment.
• Prepare samples for all the tests using optimized process methods, operating equipment, and tooling. Make detailed observations and notes during all experiments and analyze data and interpret results, as appropriate.
• Prepare written documentation of work performed (protocols, data, observations, summaries, technical reports, lab notebooks) and conduct technical presentations.
• Support manufacturing clinical trial materials.
• Cook up coordination activities with internal stakeholders and communicate with suppliers to obtain technical information on equipment and materials.
• Aid in developing material/product specifications and test methods and associated documentation.
• Perform inventory control in relation to the materials for formulation developmental work.

Qualifications

• Obtain a bachelor’s degree in Chemical Engineering, Chemistry, Polymers or Material Sciences or related field.
• Have at least 4 years of formulation and process development experience in the pharmaceutical industry.
• Possess prior experience in pharmaceutical industry or academia on topical/transdermal/transmucosal drug delivery formulation.
• Understand the physicochemical properties of drugs, materials, and polymers and apply that knowledge to develop dosage forms for application to skin.
• Master the areas of adhesive systems, mixing, coating, extrusion, converting, and/or packaging operations.
• Be a team player capable of leading cross-functional teams.
• Be motivated and results-oriented.
• Have good interpersonal and communication skills.
• Have excellent technical writing and presentation skills.
• Have background in mixing, coating, laminating, physical and mechanical characterization of transdermal and transmucosal dosage forms and in vitro formulation evaluation.
• Understand transport phenomena in the aspects of thermodynamics and kinetics.
• Have proven ability to independently plan and execute formulation experiments in a laboratory setting.
• Have knowledge of regulatory and quality guidelines pertaining to new drug products, drug/device combination products, and transdermal drug delivery systems.
• Have computer skills including word processing and spreadsheets.
• Be self-motivated and proactive to design, execute and deliver experiments and projects with a passion for creative problem-solving.
• Have the ability to lead and prioritize multiple concurrent projects, while demonstrating organizational skills for time management and flexibility to adapt to changing project directions or scopes.
• Have understanding of cGMP requirements.

Benefits

• Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program.
• 401(k) retirement savings account with a company match and immediate vesting.
• 12 paid holidays.
• Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.