GMP Upstream Chemist

Mission

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

General Responsibilities

• Performs GMP large scale peptide synthesis using solid phase peptide synthesis methodology
• Performs non-GMP grade large scale peptide purification using reverse phase HPLC methodology
• Adhere to GMP BPR and follow in-process control identified in the BPR
• Analyze and troubleshoot methods and data obtained from GMP and large-scale Research grade (non-GMP) projects
• Recommend alternatives and suggestions to improve processes, validity and/or accuracy of downstream and upstream methods
• Maintains and troubleshoots instruments, equipment and general lab areas if needed
• Maintains detained records of results which may include collecting, extraction and entering data via both electronic and paper files (i.e. notebooks, logbooks, batch records, etc.)
• Manage resources according to project priorities
• Assist in purification and synthesis method development practices such as during engineering runs, feasibility or pilot runs
• Train and assist team members. Create an environment knowledge-sharing so everyone on the ream leans and grows with the Company
• Produce and maintain food written documentation of GMP projects
• Follow 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
• Work closely with Quality Assurance and Quality Control and other departments to ensure that products meets and/or exceeds specification requirements
• Ensure implementation, compliance, and continuous improvement of QMS through SOP documentation
• Other duties as assigned by Management

Requirements

• BS or above in Chemistry, Organic Chemistry, or related disciplines.
• Strong peptide purification and analysis background
• Able to lift, push and pull up to 40lbs
• Working experience in ISO 9000, , ISO13485, cGMP environment.
• Writing technical SOPs, Batch Production Records (BPR) and technical reports
• Proficient in computer skills (MS Office, data analysis, ChemDraw, others).
• Good oral and written communication skills.
• Must be organized and detail oriented
• At least 3 years of relevant experience in biotech/life science industry environment

Job Type: Full-time

Pay: $75, $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Ability to Commute:

• Fremont, CA Required)

Ability to Relocate:

• Fremont, CA 94555: Relocate before starting work (Required)

Work Location: In person