Sr. Manager/Assoc. Director, CMC Project Management

Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by Design™ platform for CRISPR-based genetic medicine.

We are seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current role is for an experienced CMC Project Manager to join our Program Management team to support our process science and manufacturing operations to advance our platform and expanding pipeline. 

The candidate should have a passion for working collaboratively with biologists and bioengineers to enable building the necessary tools for meeting the new frontier of CRISPR-based therapeutics. The candidate will use his/her/their CMC knowledge to play a critical role in managing CMC project activities resources, and timelines, and enable CMC project leads to drive development and execution of the CMC strategy. This role will be highly interactive with stakeholders across the organization and will ensure timely communication of project information to senior leaders. The role will support projects within the research production core, as well as assets in various development stages. 

The candidate will have opportunities for professional growth in a rapidly growing biotechnology start-up, which includes growing into a leadership role of increasing responsibilities and the ability to get hands-on experience in various phases of development.

If you are seeking a role to wear multiple hats, to be involved in cutting-edge science, and to drive changes to make things happen, this position is for you!  

Key Responsibilities:

• Work with CMC project lead(s) and/or functional lead(s) to develop CMC project plans, timelines, budgets and resource requirements. 
• Act as a liaison to CDMO(s) and provide business and project management support to enable initiation and oversight of outsourced development activities. Review and provide input on CDMO agreements
• Actively manage the execution of the CMC project plan with team members, including internal and external activities, to ensure projects are delivered on-time and within budget.
• Organize and facilitate CMC functional meetings to track progress, identify/resolve issues and drive decisions.   
• Create and maintain project documentation including agenda, minutes, action items, dashboards, goals and milestones.
• Support CMC project lead(s) and functional lead(s) to identify, recommend and implement new operational processes to streamline or increase team and process efficiency.
• Ensure proactive communication of project progress and risks to senior management on a regular basis. 
• Contribute CMC operations expertise to inform comprehensive CMC strategies and project plans as needed.
• Assist in projecting CMC demands and establishing resourcing tools to support research production core and projects in various phases of development. 
• Track, coordinate, and communicate CMC regulatory filing timelines. Collaborate with team members in CMC, QA, Regulatory Affairs, among others to drive CMC regulatory filing’s quality and completion.
• Assist with the CMC portfolio review process to support the growing pipeline.
• Foster a driven, fast-paced, dynamic, and fun environment in which to do rigorous science.

Required Skills and Background:

• Have a strong scientific background, minimum of a Bachelor’s Degree in the Pharmaceutics, Chemistry, Chemical Engineering, or closely related field 
• Have a minimum of 4 years of relevant experience, including a minimum of 2 years of CMC project management experience in the biotech/ pharmaceutical industry. Regulatory filings experience a plus
• Demonstrated a track record of managing CDMOs and/or CROs
• Good understanding and experience of CMC considerations with respect to GMP, quality systems, ICH guidelines, FDA and associated regulatory requirements
• Knowledge of CMC and process development activities for preclinical and early phase assets
• Demonstrate a track record of being a fast learner and adapt to put learning into actions
• Excellent interpersonal, influencing and communication skills. Be able to distill the right amount of information and present the right level of detail to various audiences
• Be persistence, proficient and strive for excellence
• Ability to work both independently and collaboratively in a fast-paced, interdisciplinary research and development team.

Preferred Skills and Background:

• MS/PhD in Pharmaceutics, Chemistry, Chemical Engineering, or related field 
• PMP Certification is a plus
• Familiarity with CRISPR technologies and therapeutic approaches is a plus
• Previous experience in startup companies
• Knowledge of project management tools and dashboards

Salary will be commensurate with experience. We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to engineer the future of therapeutics, then we are excited to hear from you! Visit us at www.scribetx.com.  

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.