Position Summary:

Member of the TNPD group executing responsibility related to new chemical product development and application of new technologies. 

Essential Job Functions:

Participate in team meetings for assigned projects including:

• Active participant in team meetings for new products
• Participate in risk assessment activities and assessment

Implement making and evaluating prototypes

• Related formulation development and testing per USP, ICH, and other related compendials
• Device/drug history files to support design process within Sunstar
• Prepare specifications
• Preliminary regulatory understanding and classification for US and Canada,
• Contact as needed with external regulatory and quality consultants/contract manufactur
• Laboratory stock of raw materials, calibration of equipment and minor troubleshooting.
• Patent application
• Collaboration with Marketing unit to commercialize the developed products.

Lead the Laboratory stability program for New products; this includes Room Temperature Stability, Accelerated Aging Stability, Temperature Cycling (Freeze/thaw) and ICH Photostability.

The Laboratory stability program includes measuring of pH, viscosity, specific gravity, organoleptic evaluation, and quantitative and qualitative assays. Create, evaluate/monitor, maintain and/or update test methods.

Additional Job Functions:

• Test prototype samples to specification using HPLC, spectrophotometer, viscometer, pH and fluoride methods

Education

• Bachelor’s Degree of Science within a Science discipline (i.e. Chemistry, Biochemistry or similar degree)

Knowledge/Experience

• Knowledge of HPLC method development (Empower software)
• Troubleshooting Skills
• Knowledge of GMPs and GLPs
• At least 2 years previous related laboratory experience, Pharmaceutical and/or R&D preferred
• Familiar with UV/Vis spectrophotometry
• Familiarity with ICH, USP, FDA and Health Canada guidelines related to drug and device products, stability and lab testing

Skills 

• Computer proficiency: Microsoft Office, Smart Solve, MasterControl
• Basic laboratory skills for handling and mixing chemicals, SDS understanding

Abilities

• Ability to manage complex projects and timelines in a matrix team environment
• Excellent written and verbal communication, presentation, and facilitation skills
• Strong problem solving skills
• Must be able to work independently and function as a strong team player

• A business focused on health and wellness of people around the world
• High Quality Products
• Beautiful state-of-the-art facility
• Diversity and Inclusion
• Corporate Social Responsibility Program and partnership with charitable organization
• Strong value placed on company culture
• Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits. 

• Opportunities for career growth and advancement
• Employee discount on Sunstar products
• 401K retirement plan with 2.5% employer match (Pretax and Roth options)

• 401K profit sharing contribution based on company performance.
• Paid holidays and generous paid time off. Pet, Legal and Identity Theft Insurance Plans
• Competitive bonus 
• On-site café

• On Site Fitness Center
• Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
• Holiday Lunches
• Beautifully maintained walking trails
• Hybrid Schedule (certain departments)
• Numerous employee appreciation events throughout the year.
• Recognition and Rewards Programs
• Pizza With the President
• Anniversary, Birthday and New Hire Announcements

 If you’d enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.