Job Description
POSITION: Senior Quality Control Scientist
EMPLOYER: Avedro Inc.
LOCATION: 30 North Avenue, Burlington, MA 01803
HOURS: Full-time, 40 hours per week
SALARY: $130,000 to $140,000 per year
JOB DUTIES: 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 [Contract Research Organization], CRO and laboratory portfolio management. Work closely with external operation team and is responsible for quality technical aspects drug product and analytical testing at CMO [Contract Manufacturing Organization] and CMO qualified lab. Under the guidance of the Director of Quality Assurance, provide technical expertise to the Quality group, and be the point person for the quality organization for supporting all commercial, clinical supply chain external quality operations and activities for finished goods manufacturing through final finished goods distribution. 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 [International Conference on Harmonization] and other regulatory guidelines. Represent Quality on project team and partner with 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 drug product. Act as SME for evaluation of analytical test data for In-process testing, Drug substance/drug product batch release and stability data. Ensure external laboratory LIRs [Laboratory Investigation Reports], change controls, OOS/OOT investigations are documented in QM [Quality Management System]. Analyze and interpret complex data sets efficiently and accurately, and make recommendations using professional judgment to impact drug development, API stability data, and regulatory requirements. Requires up to 15% travel (domestic).
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[**Hybrid Remote permissible within MA.]
JOB REQUIREMENTS:
1. Bachelor's degree or equivalent in Chemistry or related field, and 5 years of experience in job offered or as Analytical Scientist/Chemist, or related pharmaceutical QC/QA job. Alternatively, will accept a Master's degree or equivalent in Chemistry or related field, and 2 years of experience in job offered or as Analytical Scientist/Chemist, or related pharmaceutical QC/QA job.
2. Must have experience with:
• Pharmaceutical quality, GMP QA/QC compliance or laboratory experience;
• Pharmaceutical Industry standards and regulations (i.e. 21CFR 210/211, 820, ISO 13485);
• Clinical, commercial and multiproduct facilities;
• Analytical chemistry (QC and/or R&D).
• HPLC, FTIR, UV/vis and Dissolution/Drug Release;
• Analytical method validation ICH Q2, method transfer and managing stability programs;
• Acting as Analytical Chemistry SME and providing technical guidance to junior scientists and QC chemists.
3. Good written and oral communication skills.
4. Requires up to 15% domestic travel.
To Apply, Email resume to: Avedro Inc.
Kevin Sauer - HR Business Operations Specialist II
KSauer@Glaukos.com / Ref. SQCS
#GKOSUS
About Us
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.