CMC Project Management Lead
Attralus is a newly established biotechnology company with novel protein therapeutics directed at systemic amyloidosis, which is responsible for a wide range of disease states that are currently underserved by currently available drugs. To meet our strategy of rapidly advancing our novel products into clinical trials and beyond, the company seeks the services of a project management professional to support the CMC function. Reporting to the Senior Vice President, Head of CMC, the CMC Project Management Lead will work both independently and with cross-functional teams to provide timely, high-quality support of multiple therapeutic projects. The position will function remotely, with occasional travel to the company’s Bay Area home office expected.
ROLES, RESPONSIBILITIES & EXPECTATIONS
- Develop and facilitate CMC project plans and timelines for development programs from candidate selection through IND and beyond, working independently and with stakeholders across functional areas
- Establish, document, track and communicate CMC timelines, objectives, deliverables and budgets, including assessment of progress and risks, utilizing program management methodologies
- Support management of CMC contract service providers, including vendor identification and evaluation, RFP development, proposal evaluation and negotiation, management of Work Orders and Change Orders, invoice review, and management of critical reagents and clinical supply chain, including international shipping as necessary
- Serve as the primary point of contact for CMC project management both internally and externally
- Manage potentially competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment
- Ensure alignment of projects with global strategic plans while identifying risks and constraints associated with CMC activities
- Lead CMC organizational meetings, providing clear agendas, definitive action items, and documentation of decisions
- Maintain clear and timely communication with cross-functional project team members and key stakeholders to maintain awareness of project status, issues, contingencies, and milestones
- Facilitate problem-solving and decision-making independently and as a member of cross-functional teams
- Responsible for CMC documentation including but not limited to: agendas, meeting minutes, action items, dashboards, risk register, mitigation plan, decision logs, etc.
- Identify and define risks, mitigations and/or contingency plans. Execute scenario planning and risk assessments, providing options for teams
- Ensure project progress and upcoming deliverables are understood by the CMC team and provide updates to management.
- Create and update near and long-term project plans with clearly defined goals. Assure on-time completion of tasks or milestones assigned to support project plans
Requirements / Qualifications
- A Bachelor’s degree with a minimum of 7 years of experience in the biotechnology and/or pharmaceutical industry, and a minimum of 4 years in CMC project management
- PMP or equivalent certification is desirable
- Demonstrated ability to utilize project management and document storage tools is critical
- In-depth knowledge of biopharmaceutical drug development, especially CGMP, is essential
- Hands-on technical experience in CMC development of biologic products is desirable
- Early-stage clinical drug development experience is critical; experience in late stage development and commercial readiness is also desirable.
- Experience in the authorship or organization of CMC regulatory filings is advantageous
- Experience working with and managing relationships with CDMOs and CTOs is essential
- Outstanding organizational, interpersonal, written and oral communication skills are critical, both within and outside of the company
- Experience working in a fast-paced, startup / small company corporate environment is a significant advantage
Does this sound like you? Then we'd love to hear from you.