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- BS/MS in Chemistry or related Scientific Discipline with a minimum of 8 years of pharmaceutical experience or equivalent combination of education and experience with testing Finished Products, Raw Materials, and Analytical Method Verification, Validations and Transfers.
- Advanced technical skills in HPLC and GC required, including theoretical understanding of technique, troubleshooting, maintenance and consumable replacements.
- Advanced level of Chromatography Data Software (CDS) preferably Empower 3.
- Ability to enable quantification for assays and impurities calculations, create custom calculations, and design chromatographic reports in CDS.
- Able to interpret data, including evaluation of stability testing for trends.
- Demonstrated use of analytical techniques in support of product development activities.
- Comprehensive knowledge of current Good Manufacturing Practices (cGMP), regulatory requirements, and ICH Guidelines
- Understanding and adherence with CFR 21 Part 11 requirements.
- Understanding, Knowledge, and performing of Raw Material qualifications of new incoming raw materials along with annual review requirements for existing Raw Materials.
- Comprehension and ability to follow procedures of various pharmacopeias (USP, EP, JP).
- Comprehension of regulated guidance (WHO, FCC, FDA, and ICH)
- Understanding and basic regulatory requirements and applies knowledge appropriately to activities.
- Demonstrated ability to work well in a fast-paced setting with teams.
- Self-starter with a strong work ethic.
- Must possess problem solving skills.
- Must be able to operate with minimal supervision.
- Demonstrated ability to train and/or mentor employees.
- Excellent written and verbal communication skills.
- The Ability to analyze Finish Good Products and Raw Materials on HPLC, GC, FTIR, and Titrations (visual and potentiometric).
- Ability to manage multiple projects and accurately project realistic timelines.
- Ability to Qualify Raw Materials by compendial testing procedures.
- Authors Analytical Method Validation or Method Verification Protocols as guided by ICH, FDA, and cUSP.
- Responsible for analytical method validation/verification/transfer from clients or R&D to QC when assigned.
- Performs testing on raw material, in-process, & finished good samples when applicable.
- Documents all data in corresponding laboratory notebook and files documentation according to approved SOP and data integrity guidelines.
- Interface with contract labs regarding QC sample handling and reporting.
- Evaluate and interpret the test results and other related technical documentation.
- Additional document writing includes, but not limited to, preparation and review of SOPs, STMs, failure investigation and process deviation report, stability study protocol/report, instrument qualification protocol/report and analytical technical transfer protocol/report.
- Other duties may be assigned as deemed appropriate by management.
- Mentors QC chemists and assists with training and professional development.
- Upholds all elements of data integrity.
- Employees are required to wear eye protection and lab coats while in the lab area.
- Work safely and follow all OSHA regulations and company safety policies and procedures.
- Ability to frequently lift and/or move up to 25 lb.
- Ability to occasionally lift and/or move up to 35 lb.
- Ability to regularly stand, sit and walk to perform tasks.
Scientist III - Lynwood, United States - PL Developments
Description
Salary Range: $85,000 - $95,000/yr DOE
JOB QUALIFICATIONS:
POSITION RESPONSIBILITIES:
PHYSICAL REQUIREMENTS: