Job Type Full-time Description Mozart Therapeutics is an early clinical phase biopharmaceutical company located in Seattle, focused on developing novel immune engagers that specifically target a subset of T lymphocytes to delay the onset and ameliorate pathology of autoimmune diseases. We are developing first-in-class immune modulators that specifically target a novel regulatory T cell network. The company is seeking a highly motivated and experienced individual to join the CMC group. The ideal candidate will work in a dynamic start-up environment to perform project management of our chemistry, manufacturing, and controls process, joining a team focused on the discovery, generation, and development of therapeutic candidates in inflammatory and autoimmune disease. The CMC Project Manager will work closely with CMC Leadership and team members across functional areas to drive effective execution of CMC deliverables through program and project management support. They will play a key role in the management and integration of cross functional CMC activities partnering closely with team members as well as functional leads to orchestrate development and ensure execution of CMC plans, timelines, and budgets that are aligned with CMC and overall program strategy. CMC Project Planning Facilitate development and execution of CMC project plans by ensuring:
- Identification of critical program assumptions/activities/constraints.
- Integration of detailed execution and long-term development plans across the various CMC areas such as: drug substance development, drug product formulation and process development, analytical method development and validation, manufacturing, release, material characterization and stability testing, product control strategy, CMC regulatory interactions, and report/submission planning and execution.
- Proactive analysis of potential risk areas, including identification and implementation of mitigation and/or contingency plans.
- Build and monitor fully integrated project schedules capturing all manufacturing activities and resources needed in accordance with corporate goals, scope, budget, and risks.
Project Management, Budget, & Tools
- Create regular project reporting including CMC program budgets, timelines, and appropriate risk analysis.
- Facilitate internal and partner/CDMO CMC meetings, including scheduling, developing agendas, writing and distributing meeting summaries, and tracking goals and action items to completion.
- Establish and manage collaboration and team sites. Create, organize and maintain CMC documents for access by the project teams and coordinate timely CMC document review/approval to support development, manufacturing, Regulatory and Quality activities. Track delivery and create repositories for all Process Development deliverables.
- Contribute to the establishment and enhancement of CMC project management tools and best practices to ensure we are providing effective PM support to the teams &/or the organization.
- Implement new processes and process improvement initiatives designed to improve the efficiency and effectiveness of the Project management function.
Team Alignment
- Provide overarching project management support to a CMC teams for multiple programs, fostering an environment that encourages clear and open communication, strong collaboration across departments and sites, curiosity and ingenuity, discussion of challenges &/or opportunities, and problem solving with an enterprise mindset.
- Establish strong partnerships with internal and external team members to lead effective decision-making and risk/opportunity scenario planning and developing strategies.
- Support external vendor oversight, contract development, and budget alignment and management.
- Partner with key stakeholders, with a need to understand the Clinical Development plans and strategy to enable alignment with toxicology, clinical and commercial targets.
Requirements
- Work effectively in a fast-paced, matrix environment to integrate CMC team efforts across multiple programs.
- Apply Project Management Best Practices and demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement project management process improvements.
- Project management skills, along with critical thinking and problem solving, negotiation skills, conflict resolution, influencing skills, and team building skills.
- Experience managing cross functional teams with timeline management and budgetary responsibility
- Experience working on regulatory submissions for biologics.
- Expert knowledge of Smartsheet, MS Office (PowerPoint, Word, Excel), SharePoint.
- Strong understanding of drug development, including in-depth knowledge of CMC functions and the strategic and operational requirements from IND to commercial launch.
- Knowledgeable in cGMP manufacturing and CMC regulatory requirements for biological pharmaceuticals.
- Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders.
- Ability to travel domestically and/or internationally to CDMO sites, when required.
EDUCATION AND EXPERIENCE:
- BS/MS in a scientific or bioengineering discipline.
- 10 years of experience in the Pharmaceutical, Biotechnology or other related field
- Minimum of 6 years of CMC program/project management experience in the pharmaceutical or biopharmaceutical industry
- Project Management Professional (PMP) or Biotech PMP certification preferred
The salary range is $112,970 min to $173,030 max. Fully qualified candidates will be paid in proximity to the salary mid-point. Mozart Therapeutics has an innovative, fast paced, collaborative culture looking to hire individuals who are seeking to make a significant contribution to advancing and developing novel CD8 Treg modulators that target a subset of T lymphocytes to improve clinical outcomes in patients with autoimmune diseases. We are a well-funded privately held biopharmaceutical company founded in 2020. We offer our employees competitive compensation including annual performance bonuses and stock option grants. The wage range shown is based on the job posting's primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location, in addition to internal equity and alignment with market data. Benefits include paid vacation, paid sick leave, paid holidays, and paid time off between Dec 25 and Jan 1, medical, dental and vision insurance, life insurance, 401(k) with company matching. All benefits are non-contractual and may be amended, terminated, or enhanced as Mozart Therapeutics deems necessary. We are an equal opportunity employer. Salary Description $112,970 - $173,030