Director, Project Manager, CMC
We are currently seeking a qualified, highly motivated, experienced individual for the position of (Sr.) Director Project Manager, CMC 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.
WE CAN OFFER YOU:
- The chance to join a successful and growing organization with an unmatched leadership team, passionate about their employees.
- An opportunity to make a real impact on chronic kidney disease patients with our cutting-edge therapeutics.
- A supportive, collaborate work environment, with colleagues who care about the success of the organization.
- A place that will treat you fairly, provide competitive compensation, on-going recognition, and most of all, a chance to learn, contribute and develop your skills.
- Fun, enthusiasm, support, a passion for healthy living and never a dull moment…
The 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 Director will report to the Vice President 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, quality assurance, regulatory and clinical operations, to ensure timely manufacturing of drug substance and drug product, regulatory agency updates, and supply of clinical trial material.
- Lead project management efforts associated with CMC activities to support manufacturing and release of drug substance and drug product, manufacturing process improvements, process validation, analytical method development and transfer, and product launch 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, budgets 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.
- Conduct internal CMC team meetings and draft minutes to ensure regular, efficient team, and stakeholder communication.
- Support writing, review, publication and filing of CMC related regulatory documents and 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.
EXPERIENCE AND SKILLS:
- BS degree in scientific field plus at least 10 years of experience in the biotechnology or pharmaceutical industry.
- Minimum of 6+ 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 clinical and commercial project management 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, stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday will also be provided according to company practice.
Tricida is located in South San Francisco, CA and this is an on-site position.
SEND RESUMES TO: email@example.com and indicate Job Code 310.137
Tricida is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.