Associate Scientist – CMC R&D

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.

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:

No special requirements
Stress:

High-paced, demanding environment to meet manufacturing schedules
Travel:

Travel not expected.