- Lead cell culture and cell line process development for early and late stage with a focus on productivity, quality and speed to IND and clinic
- Manage and support cell culture and cell line process development activities at CDMOs i.e. design and review studies and technical reports
- Technology transfer and scale up
- Oversight of non-GMP and GMP upstream drug substance manufacture at CMOs, from phase I to commercialization
- Author and review internal and external documentation, technical memos and manufacturing investigations (change controls, deviations, CAPA, etc.)
- Contribute to regulatory strategy and submissions (IND/BLA)
- Manage, evaluate, and maintain critical data and records of all process development operations in support of regulatory requirements for multiple projects.
- Partner with CMC and Quality, to support cGMP manufacturing.
- Work collaboratively with SMEs in other CMC areas such as formulation and analytical to develop sound, integrated plans for development and manufacturing
- Act as an SME on behalf of process development for internal team meetings, updating dashboards and presenting to the group where appropriate
- Recruit, train, motivate, develop, and mentor Process Development staff
- Define and manage technical projects with focus and urgency
- BS/BA in biology, biochemistry, chemical engineering, or related degree and 12+ years of related experience or MS/MA with 10 years related experience or PhD with 6 years related experience
- Technical knowledge in mammalian cell culture process development
- Extensive experience in a biologics upstream process development laboratory
- Preferred: Experience with monoclonal antibodies and/or fusion proteins
- Preferred: Cell line development and/or DoE and statistics
- Extensive experience in pre-IND and pivotal cell culture process development and implementation in GMP facilities
- Experience with tech transfer and/or process validation - manufacturing sciences
- Preferred: Experience working with and managing third party vendors.
- Additional experience under consideration includes analytical and purification development
- Knowledge of cGMPs, regulatory guidelines, validation practices and other relevant regulatory requirements
- Excellent judgement and problem-solving skills, including negotiation and conflict resolution
- Can do attitude and executing the ever-changing tasks needed in a small company environment.
- Strong oral/ written communication skills. Excellent interpersonal/organizational skills and the ability to multi-task.
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 15 % domestically and internationally.
- The salary range for this position is commensurate with experience
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Associate Director, Cell Culture Process Development - 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 Director, Process Development, the Associate Director of Cell Culture Process Development is responsible for the management of cell culture and cell line process development to advance drug substance through development and commercialization. The incumbent will work remotely and collaboratively with internal stakeholders and be responsible for the process development, tech transfer, and oversight of engineering/clinical batches at contract manufacturing sites.
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.
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):
•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.
