We seek an Associate Director, CMC Project Manager skilled in pharmaceutical late phase drug development and commercialization to support project management of our Chemistry Manufacturing and Control (CMC) activities in conjunction with internal subject matter experts and external project managers from Tricida’s CMOs. The Associate Director will be responsible for planning and on-time completion of a variety of drug manufacturing and testing activities including the management of deliverables and ongoing risk mitigation. The Associate Director will report to the Senior Director, CMC Project Management. The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of drug development, preferably demonstrated with previous drug development and commercialization experience. The position will collaborate closely with cross-functional team members, including process chemistry, drug product manufacturing, analytical chemistry, regulatory and clinical operations, to ensure timely manufacturing of drug substance and drug product, regulatory agency updates, and supply of clinical trial material.
- Assist in project management efforts associated with CMC activities to support manufacturing and release of drug substance and drug product, manufacturing process improvements, analytical method development and transfer, and shipping related activities.
- Provide project coordination and communication in support of multiple CMC projects at Tricida’s CMOs, including participation in technical calls and face-to-face meetings, development of agendas, creation of meeting minutes, tracking of action items, and scheduling of follow-up meetings.
- Facilitate cross-functional planning of CMC activities across departments and disciplines to align dependencies, schedules, funding and delivery commitments.
- Proactively identify potential risks, resource constraints, and conflicts that could impact project timelines; collaborate with the development team to develop appropriate solutions.
- Schedule, conduct, and draft minutes for internal CMC team meetings and ensure regular, efficient team, and stakeholder communication.
- Support writing, review, publication, and filing of CMC related regulatory documents and health authority interactions, including those associated with INDs, CTAs, IMPDs, NDAs, and PAIs.
- Assist in preparing presentations, updating corporate project plans, etc.
- Perform additional responsibilities as deemed necessary by management.
Experience & Skills:
- B.S. degree in scientific field plus at least 7 years of experience in the biotechnology or pharmaceutical industry.
- Minimum of 3 years’ experience in Project or Program Management at a biotechnology or pharmaceutical company with direct involvement in the CMC area.
- Experience in a GMP environment is required; drug substance and drug product manufacturing experience preferred.
- Strong understanding of pharmaceutical product development, including US and EU pharmaceutical regulations.
- Experience working in cross-functional, global, virtual environments. Excellent interpersonal and organizational skills, with an ability to build relationships at all levels of the organization, including external vendors.
- Excellent verbal and written communication skills. Demonstrated ability to influence peers and stakeholders in business and technical roles.
- Demonstrated ability to exercise independent judgment and strategic thinking with minimal supervision.
- Microsoft Project (or Smartsheet), PowerPoint, Excel skills are essential. SharePoint experience preferred.
- PMP certification a plus.
- Ability to travel up to 10%, domestic and international.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Stock Options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday.
To apply for this position, please send resumes to email@example.com and indicate Job Code 310.125