Sr. Scientist, Quality Control

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary

The Senior Scientist, Quality Control (QC) is an experienced individual contributor responsible for performing both routine and non-routine analytical testing of in-process, release, and R&D samples. In addition to bench work, this position contributes to laboratory investigations, deviations, out-of-specifications (OOSs), CAPAs, and change controls. Additionally, the individual will apply their advanced technical experience to troubleshoot instrumentation and methods.

The ideal candidate brings deep, hands-on experience from a commercial cGMP QC laboratory, helps maintain a compliant and inspection-ready environment, upholds the highest standards of data integrity, and serves as a technical subject matter expert (SME) and as a mentor to QC team members under the direction of QC management

Responsibilities

• Independently perform routine and non-routine analytical testing of IPC, release, and R&D samples in compliance with approved methods, specifications, and cGMP requirements
• Maintain advanced technical proficiency in analytical instrumentation, with required expertise in HPLC systems and chromatographic data systems (e.g., Empower); proficiency with additional QC instrumentation (e.g., GC, dissolution, Karl Fischer, particle size, spectroscopy) is a plus
• Troubleshoot, maintain, and help optimize laboratory instrumentation, working with vendors as needed to resolve complex equipment issues and minimize downtime
• Lead the technical aspects of laboratory investigations, including deviations, OOS, and atypical results
• Contribute to method lifecycle activities including method development, qualification, validation, transfer, and revalidation
• Apply scientific principles, critical thinking, and sound judgment to solve complex technical problems
• Author and review quality system documentation, including SOPs, protocols, deviations, OOS investigations, CAPAs, and change controls
• Perform technical review of GxP and other laboratory documentation in accordance with Good Documentation Practices (GDP) and ALCOA data integrity principles
• Bring a continuous improvement mindset focused on strengthening GMP compliance by proactively identifying gaps, suggesting improvements to procedures and data integrity controls
• Help maintain a safe, organized, and inspection-ready laboratory environment, including proper management of samples, standards, reagents, and supplies
• Serve as a QC technical SME during regulatory inspections
• Serve as a technical mentor and resource for QC team members, including informal coaching, training on techniques and instrumentation, and peer review of analyst work

Requirements

Education and Experience

• Minimum of a B.S. degree in Chemistry, Biochemistry, or a related discipline
• Minimum of 10 years hands on experience in a commercial cGMP pharmaceutical QC laboratory

Knowledge, Skills, and Abilities

• Strong, hands-on understanding of cGMP regulations, data integrity expectations, and documentation practices
• Proven experience authoring and reviewing quality system documentation (e.g., deviations, OOS investigations, SOPs, change controls)
• Advanced knowledge of HPLC operation, maintenance, and troubleshooting
• Strong analytical, problem-solving, and critical thinking skills with exceptional attention to detail
• Ability to manage multiple priorities in a fast-paced, regulated environment
• Excellent written and verbal communication skills

Benefits

Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Recruiting Agencies, Please Note:

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.