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.
The ideal candidate will be innovative and highly motivated with a strong background in program management and drug development with recent product launch experience. The candidate has a proven ability to manage a cross-functional launch and program team, driving results, to ensure launch priorities are set and milestones are achieved. The candidate will be a team player with well-developed skills for gaining the cooperation of others and ensuring effective communication among team members.
Reporting to the Director, Process Development, the Manager/Sr Manager of Cell Culture Process Development is responsible for leading a molecule for cell culture and cell line process development to advance drug substance from development to commercialization. The incumbent will work in a hybrid model 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 are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
- Lead cell culture and cell line process development for an antibody or fusion protein process
- Manage and support cell culture and cell line process development activities at CDMOs i.e. design and review studies and technical reports
- Focus on speed to clinic, technology transfer and scale up
- Based on an outsourced model, oversight of non-GMP and GMP upstream drug substance manufacture at CMOs, from phase I to PPQ/PV
- Author and review internal and external documentation, technical memos and manufacturing investigations (change controls, deviations, CAPA, etc.)
- Review and approve batch master batch records, bills of materials, executed batch records, etc.
- Manage, evaluate, and maintain critical data and records of all process development / MS&T operations in support of regulatory requirements for multiple projects
- Partner with Quality, to support cGMP manufacturing using Quality Systems tools
- Work collaboratively with SMEs in CMC such as formulation, analytical, and device and team members
- Data mine and support preparation of IND/IMPD
- Act as an SME on behalf of process development for internal team meetings, updating dashboards and presenting to the group where appropriate
Qualifications:
- Minimum requirement: BS/BA in biology, biochemistry, biological/chemical engineering, or related degree and 7+ years of related experience or MS/MA with 5+ years related experience or PhD with industry experience
- Technical knowledge in mammalian cell culture process development (lab based)
- Preferred: Experience with monoclonal antibodies and/or fusion proteins
- Preferred: Cell line development
- Experience in process development and/or manufacturing sciences in pre-IND and pivotal cell culture process development and implementation in GMP facilities
- 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 10%
- 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.