MISSION

The GMP Chemist will be responsible for handling all peptide purification techniques under cGMP requirements and be accountable managing all phases of their assigned projects from concept through to release, ensure adequate prioritization, proper documentation and timely execution of the projects. This individual will work closely with Synthesis, QC, Sales and other areas in production.

General Responsibilities

• Performs large scale peptide purification using reverse phase HPLC methodology.
• Performs sample preparation and analysis using analytical HPLC for purity and mass spectrometry for identity.
• Analyzes and troubleshoots methods and data obtained from individual projects;
• Recommends alternatives and suggestions to improve processes, validity and/or accuracy.
• Maintains and troubleshoots instruments, equipment and general lab areas if needed;
• Maintains detailed records of results which may include collecting, extracting and entering data via both electronic and paper files (i.e., notebooks, logbooks, batch records, etc.)
• Manage resources according to project priorities.
• Assist is method development practices.
• Train and assist team members. Create an environment knowledge-sharing so everyone on the team learns and grows with the Company.
• Produce and maintain good written documentation of GMP projects;
• Follows protocols, SOPs, and batch production records while adhering to good documentation practices (GDP).
• Manipulates, interprets and/or presents results; prepares charts and graphs for presentations and publications as needed;
• Tracks and summarizes lab supply expenses; orders and maintains inventory of reagents, lab supplies and consumables and requests quotes for external vendors and verify accuracy of invoices.
• Participate actively in joined projects.
• Work closely with Quality Assurance/Quality Control and other departments to ensure that products meet and/or exceed specification requirements.
• Ensure implementation, compliance, and continuous improvement of QMS through SOP documentation.
• Other duties as assigned by Management.

Requirements

• Bachelors in chemistry, organic chemistry, biochemistry or equivalent experience.
• Strong peptide purification and analysis background.
• GMP experiences a plus.
• Writing technical SOPs, Batch Production Records (BPR) and technical reports.
• Work experience biotech/life science industry environment preferred.
• Good oral and written communication skills.
• Must be organized and detail oriented.
• Experience working in a global atmosphere is a plus.
• Proficient in computer skills (MS Office, data analysis, ChemDraw, others).

 AnaSpec, Inc. is an equal opportunity employer offering a competitive compensation and benefits package including medical, dental, vision, life insurance, health and dependent care flexible spending accounts, short-term & long-term disability, 401(k), profit sharing, paid holidays, sick and vacation pay and other benefits!