Under supervision of Formulation Chemist, this position will be responsible for the support of new product development of Young Dental's Prophy Paste, Fluoride Varnish and other chemical products.

ESSENTIAL DUTIES:
Assist in the Product Development Process to help increase pace of development for Class I and II medical devices or drugs products

• Responsible in gathering raw materials, making lab batches/prototypes and prepare samples requests for Branded, Private Label and OEM customers. Complete evaluations as outline in finished product and/or stability specifications.

• Assist in developing analytical and physical test methods including validation for all related chemical products and/or in correlation with the hygienist performance evaluations in the field.

• Work with process engineer in pre-weigh and scale up for pilot/production batches and prepare stability samples for the entering of the stability program.

• Assist in managing R&D stability by preparing stability samples, writing stability protocols, create stability specifications, perform physical and analytical testing, entering data/result in software and write reports.

• Write and review documentations to include

  • Raw material, Finished Product and Stability Specifications

  • Batching and Packaging Records

  • Validation Protocols and Reports

  • Standard Operating Procedures

• Assist in new product development line extension and/or contract manufacturing for new customers with supervision

• Assist in compiling documentations using MS office software to support the development of design history file (DHF).

MINIMUM QUALIFICATIONS:

• B.S. in Chemistry, Biochemistry, Chemical Engineering or Biomedical Engineering
• 2-4 Years of experience in medical device, pharmaceutical, or food product development. Applicants with significant internships or a full Co-op term in an applicable field would qualify.

Knowledge, Abilities and Skills

• Ability to work in groups
• Strong verbal and written communication skills
• Strong analytical and problem solving skills
• Intermediate knowledge of Laboratory Equipment and Analytical Testing Instrumentation –mixers, homogenizer, pH determination, fluoride content determination, viscometer, loss on drying, specific gravity, melting point, refractometer and FTIR.
• Intermediate knowledge of MS Word and Excel
• Demonstrated ability to manage multiple projects
• Basic knowledge of data interpretation

• Office environment, with Sitting and Standing for long periods of time.

• Occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.

• Periodic lifting or moving objects 40 lbs. or less.

• Ability to travel 10% or less. Visit trade shows, vendors, or customers to provide technical assistance when nee

• Design of Experiments

MINIMUM QUALIFICATIONS:

• Basic knowledge Product or Process Validations
• Basic knowledge of cGMP and regulatory requirements

 PHYSICAL REQUIREMENTS:

• Office environment, with Sitting and Standing for long periods of time.

• Occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.

• Periodic lifting or moving objects 40 lbs. or less.

• Ability to travel 10% or less. Visit trade shows, vendors, or customers to provide technical assistance when needed.