Sr. Chemistry Specialist

  • Irvine
  • Confidential
  • 3-8 years
  • 25 Mar 2015

  • R&D/ Research & Development, Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Essential Job Functions:

Provide QA Chemistry Support to the Irvine plant
Right, collect, organize, compile, and review protocols, data and report to comply with regulatory requirements
Investigate deviations to determine the impact on the product quality, the root cause and corrective actions to preclude further impact. Evaluate technical problems and provide recommendation for corrective actions
Conducts hands on experiments or as necessary to solve problems and provides technical guidance to team member on routine and special tasks
Create, review and approve QA chemistry protocols, specifications, test methods and SOPs
Authors, reviews and approves study protocols, reports and any other documents related to analytical methods development and validation, feasibility study, material qualifications and technical investigations follow cGMP, ICH, CFR and USP guidelines
Periodically follow and implement USP FDA ICH changes and updates impacting QC, manufacturing and Pharm. D.
Coordinates/manages sustaining projects such as alternate raw material qualification
Support R&D and other special projects, attend project meetings and keep abreast of the progress
Coordinate and monitor the annual reserve sample selection and storage
Interface and coordinate with various departments, especially regulatory affairs for FDA submissions
Review/approve and assist in writing the CMC for regulatory submissions. interaction with FDA center and local districts
If needed act as team leader supervising and guiding all activities associated with the methods development, method validation, verification, formulation development, raw material qualification and the new product feasibility for QC chemistry group
Designs validation and investigation strategies
Reviews work, results, data, reports and any other documents generated by others for compliance to current requirements
Generates monthly reports
Assist manager and department budget preparation

Qualifications Guidelines:

Candidates must possess a BS degree in Chemistry or scientific discipline with minimum of 3 years experience in pharmaceutical industry.
Basic understanding and experience with pharmaceutical products especially injectable products LVPs and SVPs
Knowledge of microbiological and biological testing
Strong knowledge and understanding of cGMP, USP and CFR/FDA requirements and guidelines, AOAC and EP
Written and verbal English skills with experience in writing protocol reports and proposals
Good communication interpersonal skills
Technical writing skills and experience with writing protocol reports and proposals
Knowledge of LIMS, SAP and data management/analysis software and statistical data analysis
Experience in operations planning, budget planning and staffing.
Provides leadership and technical decision to management and other technical personnel regarding regulatory issues
Basic understanding/experience in formulating parenteral injectables
Basic understanding of manufacturing processes
In-depth understanding of different technologies and chemical analyses in pharmaceutical developments such as: Wet chemistry, MS, HPLC, GC, MS, FT-IR, UV-VIS, Polarimetry, AA and general laboratory techniques and practices
Understanding of the pharmaceutical products and process development
Proven good organization leadership skills