Chemical Engineer (14-134) FibroGen
THIS JOB HAS EXPIRED Description:
Reporting to the Department Senior Director, the successful incumbent will focus on process safety, scale up manufacturing and process validation associated with new small molecule pharmaceuticals
Responsibilities will include:
Working in multi-functional teams to develop scalable processes which supplies API for safety testing, clinical trials and formulation development.
Supporting API projects through all phases of development (Phase I to Process Validation including commercial manufacturing).
Assisting in oversight of CMO activities related to technology transfer, optimization, scale-up and manufacture of drug substance
Ensuring that CMO is managing material handing appropriately and that processes are run safely
Providing significant support for process validation projects including criticality assessment, writing/reviewing process validation documentation, and process validation execution.
As needed, providing on-site monitoring of drug substance manufacturing at contract sites, and support of investigations and deviations
Reviewing, verifying and approving process documentation and batch records for cGMP drug substance manufacturing
Regularly reporting work status and preparing written reports on work performed
Reviewing drug substance documentation and reports for technical accuracy in support of regulatory filings
Cooperatively working with personnel in Chemical Development and with personnel from other departments: Analytical Development, Formulation Development, Quality Control, Quality Assurance, Regulatory Affairs, and Project Management
PhD in Chemical Engineering
At least 5+ years in chemical engineering associated with development of pharmaceutical small molecules
Skills focused on optimization of unit operations such as reactions, distillations, extractions, membrane separations, chromatography, crystallization, centrifugation, filtration, drying and milling.
A technical background in kinetics, thermodynamics, fluid mechanics, mass transfer and heat transfer.
Experience writing technical reports
Analytical skills are desirable, such as HPLC, GC, NMR, microscopy, FTIR, DSC, and/or on-line techniques
Team player with ability to positively communicate with team members
A basic understanding of government regulation such as FDA cGMPs, ICH guidance EPA hazardous waste regulations, local and federal environmental regulations, and OSHA chemical hygiene plans.
Knowledge and understanding of the CMO industry and sources of commercial chemicals
Experience with transfer, scale-up and process validation of chemical processes to commercial facilities
Hands-on experience with pilot plant scale-up and/or larger scale chemical synthesis desirable
Ability to analyze extensive data sets and communicate a summary of their analysis effectively
Proficiency with word-processing, spreadsheet, chemical drawing, simulation/modeling, statistical, and project management software (i.e. MS Word, Excel, ChemDraw, Dynochem, Vismix, Aspen, CFD, JMP, Design Expert, MS Project).
||San Francisco, CA |
THIS JOB HAS EXPIRED