Contract Analytical Chemist (Small Molecule/Drug Development and Manufacturing) - RTP Pharma/Top $$
Our client, an RTP area pharmaceutical company with multiple products on the market and multiple products in development, is actively recruiting for a knowledgeable and capable Analytical Chemist to join its Manufacturing Analytical team.
This position will begin as a contract (6-12 months) with potential for extension. Company will pay excellent wage to attract and retain an excellent candidate.
Key Things to Note:
- This company is developing a portfolio of sterile products and is one of the fastest-growing companies in the Triangle. It is a cGMP-compliant operation and related industry experience is required.
- This position supports small molecule products in all stages of the development process.
- This is a lab-based role. Most work will be performed on site and strict safety measures are being enforced.
- Role will involve executing experiments towards the development and validation of analytical methods, generating data for process understanding and the establishment of specifications
- Experience with HPLC, GC, GC-with headspace, Karl Fischer, UV, IR, pH, TLC, particle size testing, and other physical testing will be essential
- The company uses Empower software, experience with Empower will be important.
- Perform analytical chemistry to develop and validate analytical methodology, mainly stability-indicating HPLC methods, for new drug substances or drug products.
- Perform and verify compendia methods when appropriate.
- Generate analytical data for new and existing methods to trouble-shoot issues.
- Design and execute method validation protocols (including forced degradation studies).
- Execute stability studies to support the development of new drug substances or drug products.
- Assist in laboratory investigations for aberrant and out-of-specification data
- May author technical documents such as, stability reports, and certificates of analysis
- Conduct work in compliance with cGMP, safety, and regulatory requirements
Targeted candidate will offer a scientific degree (advanced degree preferred) and 5+ years of experience performing analytical testing and method development in industry. Knowledge of cGMP standards is expected.
Other priorities include:
- Strong laboratory skills in analytical testing for small molecules; Drug Development and Manufacturing experience is preferred
- Substantial experience with HPLC
- Familiarity with GC, GC-with headspace, Karl Fischer, UV, IR, pH, and particle size testing
- Empower software experience
- Excellent documentation skills
- Collaborative, congenial work style combined with ability to work independently, once trained
Finally, we seek a candidate who will thrive in this fast-paced, highly dynamic setting. A lot is happening. We seek a flexible and versatile candidate who is ready and able to contribute broadly.
Please forward resume for prompt consideration. Local candidates only.