R&D Formulation Chemist - St. Petersburg, FL | Biospace
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R&D Formulation Chemist

R&D Partners

Location:
St. Petersburg, FL
Posted Date:
8/22/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Dermatology, Formulation, Regulatory,

Job Description

 The R&D Formulation Chemist II will be responsible for all aspects of product development for topical cosmetic, medical device, OTC/RX products, such as formulation development, sourcing raw materials, and overseeing the process from scale-up through launch. Working on multiple projects simultaneously, this individual is responsible for designing experiments to support product development in a team based environment, and will conduct hands-on laboratory and bench work, while participating in multi-functional teams throughout the product development cycle.
The R&D Formulation Chemist II must understand FDA regulatory requirements and utilize GDP in a cGMP environment.
Responsibilities include but not limited to:
Formulation of new products, particularly topical cosmetic, medical device, and OTC/RX products.
Assess new projects, create project plans, and identify milestones and deadlines.
Qualify all new raw materials including initiation of supplier qualifications.
Develop Raw Material, Bulk and FP Specifications, as well as Stability Study protocols, and work with QC to establish analytical test methods.
Work closely with QA and QC on method development and validation, where applicable.
Lead manufacturing transfer process from pilot lab batches to commercial production.
Support customers and ongoing production activities by troubleshooting formulas, updating batch records, investigating product issues, etc.
Oversee change control process for R&D to include launch of new products and revision of current products.
Keep detailed records of all data for Development files, Master Batch Records, Drug Master Plans, FDA filings, etc.
Write and review technical documents including formulation development protocols and reports, SOPs, Master Batch Records and other documents
Participate in multi-disciplinary project teams (QA, QC, Production, Business Development) through the complete product development cycle.

Requirements

Bachelor's degree in Chemistry or a related field.  Master's Degree preferred.
7+ years’ of pharmaceutical/OTC formulation experience in creating creams, lotions, emulsions, suspensions, wash-off and leave on products.