Manager, Quality Control, Tech Services Waltham, MA

At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.

This a dynamic role with a diverse set of responsibilities. Reporting to the Associate Director of Quality Control, the Manager, Quality Control, Tech Services, will primarily provide oversight of Viridian’s testing program performed by outside testing laboratories. The QC Manager will review method validation at CMO/CTL, manage change and investigations, and manage release data from CMO/CTL. This position works closely with other functions within Viridian and external CMO/CTLs.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Review method qualification/validation protocols and reports. Review sampling protocols
• Manage release data across multiple programs through data review, trending, and generation of CoAs
• Drive change controls including specification changes and method changes
• Author and manage OOS investigations and Deviations. Troubleshoot issues and drive resolutions
• Collaborate with internal stakeholders and CMO/CTLs for QC testing-related topics to ensure compliance and timeliness
• Perform trend analysis including testing data to support specifications for clinical and commercial drug substance and drug products and prepare the reports. Trend assay control parameters
• Write, revise and review Quality Control SOPs
• Track and trend reference materials. Review reference standard protocols and reports
• Author CMC sections for regulatory filings
• Assist in Audits with QA
• Perform other duties as required

Qualifications:

• 7+ years of relevant experience
• Bachelor’s degree required
• Master’s degree preferred with 5+ years’ experience
• Thorough knowledge of GMP testing requirements, including Analytical Life Cycle
• Experience managing a CMO/CTLs
• Experience with technical writing for regulatory CMC sections
• Well versed in various analytical and bioanalytical techniques (e.g., ELISAs, spectroscopy, HPLC, UPLC, electrophoresis, compendial and other methods for biopharmaceuticals). Preference for chromatography experience
• Working knowledge of quality systems and regulatory requirements (ICH and 21CFR Part 11/210/211, 820)
• Experience identifying, evaluating, and closing change controls, OOS’s and investigations
• Experience with Veeva eDMS, LIMS software, statistical software, and Smartsheet preferred
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 5%
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• Fertility and mental health programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various mental, financial, and proactive physical health programs covered by Viridian

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.