Job Type
Full-time
Description
Position Summary CMC R&D is seeking candidates interested in contributing to a burgeoning field that has the potential to help millions of patients.
Essential Duties & Responsibilities
- Develop, qualify, and validate methods for protein analysis on HPLC/UPLC, capillary systems, and equivalent analytical instruments, and plate-based assays using different readers, using literature references and scientific principles.
- Ensure adherence to highest quality and efficiency standards in laboratory operations (cGLP, cGMP)
- Develop, optimize, and validate new chromatography methods
- Document laboratory work in notebooks and appropriate systems in accordance with GLP systems and internal SOPs, following compliance.
- Write and review technical documents such as study protocols, reports, SOPs, experiment summaries test method, etc.
- Foster morale and teamwork
- Performs other functions as required or assigned
- Complies with all company policies and standards
Requirements
Position Requirements and Qualifications Education:- Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 6-8 years industry experience
- Or Master's degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 6-8 years industry experience
- Or Ph.D. in Biochemistry, Biotechnology, Biology with 0-2 years' experience
- Experience with a wide variety of analytical technologies such as peptide mapping, HPLC, UPLC SEC, HIC, IEX at a minimum
- Experience in method development, as well as method qualification/verification/validation in a GLP/GMP environment
Special Skills: - Excellent communication and technical writing skills
- Ability to multitask technical responsibilities in a fast-paced, dynamic environment is required
- Proficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook.
- Experience with Empower and/or ChemStation HPLC software programs is desired.
- Experience with any or all of the following is considered advantageous: spectroscopy (UV-Vis, CD, and fluorescence), mass spectrometry, DOE software, strong knowledge of statistics.
Work Environment & Physical Demands: General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.
General Work Environment:
- Laboratory and controlled cleanroom space.
- Cleanroom gowning required.
Noise:
- Standard noise levels expected with laboratory and manufacturing equipment.
Standing/Lifting:
- Extended periods of standing and walking while working in the manufacturing areas
- Must be able to lift 15 lbs.
Visual:
Stress:
- High-paced, demanding environment to meet manufacturing schedules
Travel:
Supervisory Responsibility, if any: NoThis position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
