Location: all cities,MA, USA
Description
At Viridian, we work with a sense of urgency for patients, creating unity with our team, the industry, and the community. We are committed to using proven science and engineering to improve the lives of people living with serious and rare diseases and we are getting closer to achieving this goal every day.
Reporting to the Director of External Manufacturing, the External Manufacturing Specialist will play a critical role in Viridian's development and manufacturing operations across early phase and late-stage programs. The ideal candidate will facilitate document reviews across multiple CMC functions, assist with supply chain operations such as coordinating shipments and managing inventory, manage Quality Management System (QMS) records, and support multi-functional activities as needed.
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
* Coordinate and facilitate document reviews across Chemistry, Manufacturing, and Controls (CMC) functions & external CDMO partners to ensure compliance and accuracy
* Serve as a liaison between departments to streamline communication and resolve any document-related issues
* Manage and maintain documents in a validated document management system, ensuring version control and accessibility
* Communicate accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets for internal and external documents
* Manage and coordinate shipments of materials and products to and from external manufacturing sites
* Facilitate the initiation and closure of QMS records, including CAPAs, deviations, and change controls
* Collaborate with various departments, including Quality Assurance, Quality Control, Regulatory Affairs, Process & Analytical Development, and Supply Chain to support multi-functional activities as needed
Requirements
* Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry, Engineering)
* Minimum of 3 years of experience in biopharmaceutical manufacturing or a related field
* Strong working knowledge of Electronic Management Systems in the manufacturing of monoclonal antibodies or biologics - Veeva preferred
* Demonstrated ability to coordinate CMC documentation initiatives with external contractors such as CMO's and CRO's
* Strong time-management and organizational skills, and the ability to multitask in a fast-paced environment
* Excellent verbal and written communication skills, and the ability to work effectively in a cross-functional team environment
* Ability to work independently and manage shifting priorities while maintaining accuracy and quality
* Strong analytical and critical thinking abilities
* The position requires up to 10% travel
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.