- Set the strategic direction and operational execution plans for all work performed by Viridian's network of CMOs from pre-IND to late-stage manufacturing and process validation.
- Manage external spend budget for activities executed at Viridian's CMOs; ensure accuracy of accruals, invoices, purchase orders and budget forecasting by serving as the functional liaison with the Technical Operations FP&A Business Partner.
- Establish governance structures that facilitate timely, open communication with CMOs and internal stakeholders and the successful delivery of CMO services.
- Lead the CMO selection process in collaboration with internal stakeholders to ensure alignment with the long-term clinical and commercial manufacturing strategies across all nodes of the supply chain; includes developing and negotiating development, technology transfer, and manufacturing/supply contracts.
- Ensure product integrity by monitoring cGMP compliance at CMOs by implementing and conducting regularly scheduled Quality Business Reviews (QBRs) and by tracking standard Key Performance Indicators (KPIs).
- Identify business risks and implement appropriate risk mitigations.
- Recruit and develop talent for the newly formed External Manufacturing Function to ensure the business needs of the organization are met.
- Bachelor's Degree in life sciences, chemical engineering or related discipline required, Master's Degree a plus.
- 12+ years of experience in the Biotechnology/Pharmaceutical industry with a minimum of 7 years of experience in cGMP manufacturing operations.
- Combination drug device experience desirable.
- Progressive experience in a leadership role in pharmaceutical development and commercial manufacturing; experience partnering with CMOs required.
- Working knowledge of FDA/ICH/EMA guidelines and cGMPs; familiarity with regulatory submission requirements.
- Exemplary interpersonal, written and oral communication skills.
- Demonstrated success leading cross-functional teams with internal and external team membership.
- Understands and listens to team needs while fostering collaborative and productive team environments.
- Exhibits a degree of ingenuity, creativity and resourcefulness in a matrix organization.
- Proficient in Excel, PowerPoint, Visio, Word, and SharePoint.
- Ability to travel domestically and internationally, as required.
- The salary range for this position is commensurate with experience
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Director, External Manufacturing - Waltham, United States - Viridian Therapeutics
Description
At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. 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, strategic 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.
The Director, External Manufacturing, will report to the VP, Commercial Manufacturing & Supply Chain, and is accountable for the business, relationship and operational management of all activities performed within Viridian's Contract Manufacturing Organization (CMO) network (includes biologics Drug Substance and Drug Product manufacturing, device component production, combination device assembly and commercial finished goods production). You will partner with cross functional teams, both internal and external, to ensure operational milestones supporting regulatory submissions are met and clinical and commercial supply to our patients is uninterrupted.
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):
•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.
