Jen Lutton Email & Phone Number

Kirkland, Wa, Us

Seattle, Wa, Us

Ensure raw materials and components are inspected, sampled, and tested as per approved procedures and meet specifications.

Seattle, Washington, Us

Onboard laboratory and office spaces. EH&S: implement safety training, generate OSHA-required procedures, manage hazardous wastes. Facilities Management: supervise cleaning, plumbing, electrical, locksmith, and IT contractors. Manage building security. Execute various repairs. Quality: introduce GDP and document control practices.

Bothell, Wa, Us

Supervise raw materials systems and staff for a biologics CMO. Oversee contract testing. Data and lotfile review for material disposition. Coordination with internal customers in Procurement and Production to set release priorities. Instrument procurement and onboarding. Supplier qualification tracking. Laboratory investigation. Material change risk assessments. Compendial method verification. Functional approval of reports, specifications, and SOPs. Raw materials SME for audits. Goal setting and performance evaluations with analysts.

Bothell, Wa, Us

Supervise raw materials systems and staff for a biologics CMO. Oversee contract testing. Data and lotfile review for material disposition. Coordination with internal customers in Procurement and Production to set release priorities. Instrument procurement and onboarding. Supplier qualification tracking. Laboratory investigation. Material change risk assessments. Compendial method verification. Functional approval of reports, specifications, and SOPs. Raw materials SME for audits. Goal setting and performance evaluations with analysts.

Bothell, Wa, Us

Supervise raw materials systems and staff for a biologics CMO. Oversee contract testing. Data and lotfile review for material disposition. Coordination with internal customers in Procurement and Production to set release priorities. Instrument procurement and onboarding. Supplier qualification tracking. Laboratory investigation. Functional approval of reports, specifications, and SOPs. Raw materials SME for audits. Goal setting and performance evaluations with analysts.

Reading, making, and working on my fitness.

Paris, France, Fr

Supervision of a team of six analysts responsible for inspection, sampling, testing, and release of all GMP raw materials used in the manufacture of a commercial biopharmaceutical product. Facility environmental monitoring and cleaning validation support. Development and maintenance of raw material specifications. Staff recruitment and performance evaluation. Training of analysts in cGMP, instrument use, test technique, documentation, data review, SAP, batch release. Creation and management of raw material qualification, vendor qualification, and vendor change notification programs. Compliance auditing of raw material vendors. Planning, design, and qualification of new quality control laboratory facilities. Selection and IQ/OQ/PQ of analytical instrumentation, including HPLC, FTIR, density meter, polarimeter, TOC analyzer, pH and conductivity meters, balances. Familiarity with cGMPs, ICH, and compendial monographs. Laboratory investigation. Interaction with regulatory agencies. HPLC method development and validation. Development of CTDs, SOPs, protocols, reports. SAP subject matter expert for the QM module.

Leverkusen, North Rhine-Westphalia, De

Analytical testing of GMP raw materials as per USP and ACS monographs and in-house methods. SOP writing and revision. Peer review of data. Maintenance of raw material release specifications in SAP. SAP implementation of varied testing severity.

HPLC method development and validation. HPLC-MS, GC-FID. Quality review of contract laboratory analytical data and reports for pharmaceutical in Phase I trials. In-process testing of synthetic reactions. Stability testing of pilot formulations.

Us

QC release testing of pilot plant raw materials using compendial and in-house methods. HPLC, Dissolution testing, UV/Vis, Viscometry, wet bench methods.

Wilmington, Massachusetts, Us

Contract testing laboratory. HPLC, TLC; ELISA and Origen Analyzer immunoassays; SGS-page, IEF, cellulose acetate electrophoresis; total protein determination; TOC and conductivity testing; DNA quantitation; FTIR and UV/Vis spectroscopy. Performed assays on blood samples under Biohazard Level 2 conditions. Peer review of data, SOP writing and revision, training of new staff, support of client and FDA audits.