| Title: | Chemist - Dissolution Apparatus |
|---|---|
| ID: | 1469 |
| Location: | Dallas, TX |
| Department: | Development |
| Job Related Skills: | Analytical Chemisty, Bioavailability/Bioequivalence, Dissolution Apparatus, Pharmaceutical Development, Protocol / Technical Report Writing, SOP Writing |
Company Overview:
Synergy Bioscience is a pharmaceutical contract research organization (CRO) and laboratory testing services provider, serving the FDA-regulated companies. We are currently seeking highly qualified chemists with extensive experience and the ability to work independently on laboratory instruments and write technical reports.
Role and Responsibilities:
The successful candidate will have knowledge on how to operate, calibrate, and troubleshoot the following analytical instrument:
- Dissolution Apparatus
We looking for candidates to have substantial experience with Dissolution Apparatus. Duties will also include conducting laboratory tests, analyzing the results, interpreting data, initiating out-of-specification (OOS) procedures when necessary, and generating technical reports. Adherence to standard operating procedures (SOPs), safety guidelines, and cGMP/GDP regulatory requirements is mandatory.
Key responsibilities include:
- Maintain sample documentation and specifications to ensure product safety, verification, traceability, and Out of Specification Investigation (OOS).
- Perform pharmaceutical product development scientific studies, such as product stability, formulations, dissolution, leachable/extractable, and test methods.
Qualifications and Experience:
- Bachelor’s degree in chemistry.
- EP, USP, and JP experience (Required).
- Minimum of 5 - 7 years of experience in R&D chemistry laboratory.
- Exceptional technical writing skills.
- In-depth knowledge of US FDA regulations and the ICH Guidelines.
- Strong organizational skills.
Skills Required:
- Detail-oriented with the ability to multitask and prioritize tasks to meet deadlines.
- Demonstrated ability to use logic and reasoning to solve problems.
- Proactive in seeking direction as required.
- Self-motivated individual, capable of working hard both independently and in a team, while maintaining a focus on quality.
- Professional attitude emphasizing teamwork and cooperation.
- Manual dexterity to operate a variety of laboratory tools and equipment.
