Associate Director/Director, CMC Project management
United States (Remote)
VP, Head of CMC
Tavanta Therapeutics (Tavanta) is a clinical-stage specialty pharmaceutical company developing a diverse pipeline of small molecule, peptide and drug/device combination products that bring clinically meaningful benefits to patients with serious or debilitating diseases. As we continue to grow, there is an immediate opportunity for a CMC project management professional with a strong technical drug development background and operational experience to join our CMC Team. Reporting to the Vice President of CMC, the incumbent will be responsible to work across the organization to develop, manage, and implement project plans and timelines to align with the portfolio, and corporate strategies.
In addition, the responsibilities include engaging in research and development programs, providing technical support to ongoing projects at vendor sites to meet the timelines, generate high-quality data, working closely with Finance on budget preparation, forecasting, and planning, as well as across all functions including the Research Team located in Budapest, Hungary.
The corporate culture at Tavanta is grounded in the core values of accountability, teamwork, and support. It is the responsibility of every person to emulate and abide by these values as the company grows.
- We are all accountable for efficient and effective development of products that help patients with unmet medical needs through focus on innovative strategies and operational excellence
- We value teamwork and work in high-performing teams whose success is based on trust, transparency, and integrity
- We challenge each other. We motivate each other. We support each other.
Essential Duties and Responsibilities
- This is a highly visible role in the organization and the incumbent must be solution-oriented, flexible, and experienced with Project Management challenges in a small company
Responsibilities will include (but are not limited to):
- Engage in R&D programs. Work closely with the formulation, device, process and analytical development, clinical supply chain, quality, regulatory, project leadership to ensure execution of project plans to meet corporate objectives
- Develop and maintain CMC project timelines encompassing deliverables from both internal and external stakeholders, vendors, and contractors to identify/communicate interdependencies as well as critical path activities for development programs
- Attend Project Team meetings, represent the CMC function and ensure seamless communication and alignment between the CMC function and the PTM
- Facilitate CMC team meetings to drive cross-functional communication, timely and effective decision making, and successful execution of CMC objectives. This includes scenario planning to support the development of risk mitigation plans associated with the CMC projects
- Work with Finance and other functions on budget preparation, updates, and forecasting
- Provide technical support to CMC projects to meet the timelines and generate high-quality data
- Review technical issues at CDMOs and provide constructive solutions. Travel to sites as needed.
- Author Process Development Reports (PDRs) for IND/NDA submissions.
- Review CMC sections in IND and NDA filings
- Identify and implement efficiencies to improve collaboration, and operational excellence in the organization with respect to project communication, timelines, and deliverables
Knowledge, Skills, and Behaviors
Education and Experience
The candidate will have a Master’s degree of Science or engineering in a scientific discipline (required) with pharmaceutical/biotechnology Project Management certification (preferred). In addition, the candidate should have a minimum of 6 years of direct experience working in a senior CMC role and a minimum of 4 years as a project manager in the pharmaceutical/ biotechnology industry. Experience with development of combination products is a plus. Additionally, the candidate should have a:
- Strong working knowledge of CMC development (e.g., DS and DP process development, GMP manufacturing, analytical method development, materials characterization, and validation) as well as the supporting quality and regulatory expectations.
- Experience in managing external vendors, CMOs, and consultants, including contracts, budgeting, and tracking work to completion
- Proficient in relevant software: MS Project, Excel, PowerPoint, Word, Smartsheets, etc. in addition to general knowledge with shared work environments
- Demonstrated experience collaborating and partnering across functions and throughout levels of an organization (including executive leadership) with examples of problem-solving skills
- Demonstrated ability to think creatively, work within a team environment, and collaborate effectively in a time-efficient manner
- Experience working in smaller organizations
- Strong oral, written, presentation and negotiation skills required
- Cultural awareness working with team, vendors, and stakeholders across countries
Skills and Behaviors
The Associate Director/Director must be an enabler to internal and external teams and stakeholders.
Required skills and behaviors include:
- Team oriented and goal-driven while being self-aware of strengths and weaknesses
- Highly organized and able to work on his/her own with limited oversight
- Collaborative, creative, and open-minded, and eager to help others
- Persistent and optimistic about overcoming obstacles and uncertainty
- Flexible and willing to try/learn new things and approaches, able to roll-up their sleeves every day and execute on the deliverables and requirements of the role and the company
Per current Tavanta policy, this position will be primarily remote with the possibility of up to 20% domestic and global travel. There is a minimum requirement to visit the office about once a month.