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Senior Director, Drug Substance Development
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Viridian Therapeutics Inc. Waltham, United States· 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 therap ...
Associate Director, Device Manufacturing - Waltham, United States - Viridian Therapeutics
Description
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.
Reporting to the Vice President, Device Development & Commercialization, the Associate Director, Device Manufacturing will lead technical oversight of process development for assembly, packaging, labelling and functional testing of medical device/drug combination products.
This role will also support clinical and commercial production as well as life-cycle management.This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.
Responsibilities (including, but not limited to): Support vendor selection activities as needed.
Participate in Design Reviews as process SME to provide expert manufacturing input to ensure design robustness and manufacturability.
Act as Subject Matter Expert (SME) in support of global regulatory filings.
Create and maintain Design and Process FMEAs and other risk management tools in accordance with ISO 14971 and other applicable regulations.
Identify critical process parameters and develop control plans to mitigate risks.Assist in the development of Validation Plans, execution of I/O/PQ's as well as process validations for combination products in accordance with established regulations, corporate policies and procedures, and approved site.
Lead technology and knowledge transfer activities to external contract manufacturing sites (CMOs), including component specifications, test methods, equipment specification development, vendor / equipment selection, vendor management, acceptance testing, and qualification activities.
Perform root cause analysis for major manufacturing investigations and product complaint trends.This includes forensic analysis of complaints, and application of engineering tools (IE:
Design of Experiments).Conduct assessments of changes (component, product, process) post design transfer for impact on manufacturing process, documentation and design control elements to support change control documentation.
Support Quality during supplier audits, in accordance with CFR 820 and other applicable global regulations. Participate as needed on product quality reviews.RequirementsBachelors of Science/Engineering in Mechanical, Biomedical, Industrial Engineering, or relevant technical discipline and a minimum of 10 years relevant industry experience.
Advanced Degree (MS/M Eng) preferred.Process development and engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry, with expertise in aseptic processing (including filling), device assembly, labeling and automated inspection.
Experience with combination products such as autoinjectors and on-body drug delivery devices a plus.Demonstrated knowledge and experience providing technical oversight to drug products regulated under ISO 13485, ISO 11608, and US CFR 820.Demonstrated knowledge and experience with design controls, technology transfer and validation principles for device and combination products.
Strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions, regulatory filing and provide responses to questions from health authorities.
Ability to use risk management tools, such as pFMEA, root cause analyses, etc.Experience in preparation of source documents to support regulatory filings.
Strong organizational skills to manage resources effectively and maintain a high level of productivity within budget and timelines in a dynamic environment.
Proactive, motivated, collaborative, and accountable.Extensive intermediate to advanced computer skills (Microsoft Project, Microsoft Excel, Microsoft PowerPoint, and SmartSheet).Strong commitment to ethical standards.
Ability to travel up to 10% .The salary range for this position is commensurate with experience.
Viridian offers a comprehensive benefits package including:
C ompetitive 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.
