Salary Range: $85,000 - $95,000/yr DOE

JOB QUALIFICATIONS:

• 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.

POSITION RESPONSIBILITIES:

• 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.

PHYSICAL REQUIREMENTS:

• 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.