Senior Product Development Scientist
Our client has an opportunity for Senior Product Development Scientist.
In this role you will:
- Support product development activities from pre-formulation through formulation and product development, to transfer of the product to manufacturing
- Primary contributor of development programs of novel and generic products
- Collaborate and assist with new business opportunities
- Establish methodologies, tools and know-how required for formulation /product development
- Work closely with clients – re product requirements
- Collaborate with team to develop test methods and characterize formulations/ products
- Perform new formulations/ product characterization studies
- Write comprehension formulation development reports
- Prepare documentation package intended for raw materials, in-process materials, and the finished dosage form suitable for product filings w/ FDA
- Train, coach, and guide new team members
Benefits available to team members
- Medical / Dental Insurance
- Paid Holiday/ Vacation / PTO
- 401K w/ company match
- Life and Short/Long Term Disability
- Flex Spending Account
- Masters or Doctorate -Scientific or Engineering Field with 3-10 yrs of experience in formulation
- Previous experience in Product Development -Preferred!
- Previous experience in sublingual / Buccal and transdermal patches - Preferred!
- Ability to troubleshoot formulation/ drug product issues.
- Previous experience in developing and using analytical methods and testing- HPLC, dissolution, disintegration, etc
- Skills to be successful - highly motivated, self-driven, ability to work independently, ability to plan, prioritize tasks and meet timelines, analytical, technical writing, communication and data management skills
- 7+ yrs experience in a FDA drug/pharmaceutical/medical device industry – Preferred!
- Demonstrated in-dept scientific knowledge and experience in analytical method development, and validation – Preferred!
- Previous experience in the development of pharmaceutical dosage forms and polymeric drug delivery systems with emphasis in transdermal delivery systems and thin oral film – Preferred!
- Previous experience in statical data analysis and Qbd principles – Preferred!
- Advance understanding of polymer science, analytical development, drug and formulation characterization, optimization and scale-up – Preferred!
Keywords: product development, chemistry, biochemistry, formulation science, analytical testing, GC, HPLC, FDA, polymeric, polymer science, medical device, pharmaceutical
"By applying to this position, you are confirming that you understand the requirements needed for this position, and further confirm that you possess the necessary skills and requirements, as outlined above".