Senior Scientist II - Analytical Chemistry - QA

What You'll Do:

Based in Burlington MA and San Clemente CA, the role of Senior Quality Control Scientist will be to provide technical expertise to the Quality group. The Senior Scientist will support implementation/management of Laboratory Systems, including, but not limited to investigations, change controls, CAPA, inspection readiness, laboratory metrics, analytical method verification/qualification at CRO, CRO and laboratory portfolio management. This position will work closely with Glaukos external operation team and is responsible for the quality technical aspects of drug substance and drug product manufacturing and analytical testing at CMOs and CMO qualified laboratories.

Under the guidance of the Senior Director of Quality Assurance this individual will be the point person from the quality organization for supporting all commercial, clinical supply chain external quality operations and activities for finished goods manufacturing through final finished goods distribution. The Senior Scientist will support batch record review and release activities, to include analytical data review and manufacturing record review.

• Oversee cGMP contract testing, including review and approval of analytical methods, method validations, specifications, qualification, and stability programs at CROs and CMOs
• Ensure Quality Control related documentation (QC test methods, analytical validation and/or qualification, reference standard program, and stability studies) meet ICH and other regulatory guidelines
• Represent Quality on project team and partner with Glaukos Applied Research and Quality Control department to identify, develop, and implement specialized approaches, techniques, and technologies to study drug potency, impurity levels, elution rates, and local drug distribution.
• Manage cGMP stability programs for clinical and commercial products. Perform trend analysis and reporting on stability data for Glaukos drug product.
• Ensure external laboratory OOS and OOT investigations are thorough investigate and properly documented in Quality System.
• Analyze and interpret complex data sets efficiently and accurately. Make recommendations using professional judgment to impact drug development, and regulatory requirements.
• Review and release Clinical and Commercial batches

How You'll Get There:

• Ability to prioritize and work independently with minimal supervision and an ability to escalate issues as needed
• Requires approximately 15% travel (domestic, some international travel may be requested <5%)
• Minimum Bachelor of Art/Bachelor of Science required, Master's degree preferred.
• Minimum of 5-7 years pharmaceutical quality, GMP QA/QC/ compliance or laboratory experience
• Experience in the pharmaceutical industry with a strong analytical and quality background.
• In-depth knowledge of the industry's standards and regulations (i.e. 21CFR 210/211, 820, ISO 13485)
• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Previous working experience with clinical, commercial and multiproduct facilities
• Demonstrated teamwork and ability to work in a team environment
• Ability to multi-task in a dynamic environment with changing priorities 7+ years of experience in analytical chemistry (QC and/or R&D)
• Demonstrated capability to act as an analytical chemistry SME. Highly competent with HPLC, FTIR, UV/vis and Dissolution/Drug Release.
• Experience with analytical method validation ICH Q2, method transfer and managing stability programs.
• Experience managing external contract labs is desirable.
• Proven ability to work independently at a high level and provide strong technical guidance to junior scientist and QC chemists.

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