Formulation Engineer

Corium Innovations Grand Rapids, Michigan, United States Engineering

About this position

Formulation Engineer

Due to our continued growth, Corium Innovations is seeking a Formulation Engineer who will lead formulation and process development efforts for prototype formulations and be responsible for formulation screening, altering and optimizing process parameters and characterizing the output. This position will take the prototype from a concept stage to manufacturing stage in a cGMP environment and will problem identify and problem solve for corrective and preventive actions while maintaining project deliverables on time and within budget. Candidates must be skilled in writing technical reports, conducting investigations and troubleshooting.
Your most Innovative career move is here!
At Corium Innovations, we've led the way in innovating drug delivery technologies for millions of patients whose GI systems just can't tolerate pills, who can't remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There's so much more to deliver, and we need YOU to do it!
Our Purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients.
Our Goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution.
Our Company Values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last.
  • Celebrate Individuals: We're looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work.
  • Successful Together: We believe we're better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play.
  • Embrace Innovation: We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners.
  • Pride in Ownership: We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!
Responsibilities:
  • Plan formulation DOE and process development trials through development plans.
  • Assist supervisors on sourcing material and equipment.
  • Summarize 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. Coordinate 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:
  • Bachelor's degree in Chemical Engineering, Chemistry, Polymers or Material Sciences or related field. Higher education is a plus.
  • Minimum of 4 years of formulation and process development experience in the pharmaceutical industry.
  • Prior experience in pharmaceutical industry or academia on topical/transdermal/transmucosal drug delivery formulation is preferred.
  • Understanding of physicochemical properties of drugs, materials, and polymers and the ability to apply that knowledge to develop dosage forms for application to skin.
  • Expert knowledge in the areas of adhesive systems, mixing, coating, extrusion, converting, and/or packaging operations.
  • Team player capable of leading cross functional teams. Motivated and results oriented.
  • Good interpersonal and communication skills.
  • Excellent technical writing and presentation skills.
  • 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.
  • Proven ability to independently plan and execute formulation experiments in a laboratory setting. Knowledge of regulatory and quality guidelines pertaining to new drug products, drug/device combination products, and transdermal drug delivery systems.
  • Computer skills including word processing and spreadsheets.
  • Self-motivation and proactivity to design, execute and deliver experiments and projects with a passion for creative problem-solving.
  • 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.
  • 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.