Associate Director, CMC Project Management

The Role:
Reporting to the Senior Director CMC Project Management, the Associate Director, CMC Project Management individual will serve as an integral member of the Technical Operations team as a CMC Project Manager. The individual will partner with leads from Pharmaceutical Development, Clinical Supply Chain, Quality Assurance, Regulatory Affairs, Program Management, and Finance to formulate and drive execution of CMC development strategies for one or more products, ensuring alignment with overall program strategies, timelines, risk profile, and budget.  Has a passion to develop new medicines for patients with cancer.
 
The individual will work with the CMC team to coordinate cross functional activities including, but not limited to process development, analytical development, technical transfers, formulation development, clinical manufacturing, regulatory documentation, commercial planning, and vendor management.  

The project manager will support technical teams and manage associated projects both in-house and at Contract Development and Manufacturing Organizations (CDMOs). The successful candidate will have a strong understanding of the functional operations of Chemistry, Manufacturing, and Controls supporting development of small molecule/oral solid dosage forms with a history of success in clinical stage CMC project management in the biotechnology industry.   

Responsibilities:
•    In collaboration with technical leads, develop and manage risk mitigated CMC development strategies and project plans
•    Coordinate and lead CMC Team meetings, including assembly of agendas and meeting minutes
•    Ensure effective cross-function and cross-project communications in and out of internal development teams
•    Support technical leads with vendor management including but not limited to contract review and negotiation, timeline management, and quarterly business review meetings
•    Collaborate with Pharmaceutical Development and finance to forecast and manage the budget and quarterly accrual for all CMC activities
•    Support Pharmaceutical Development with Request for Proposals, contracts, POs, and invoice approvals
 

Competencies:
•    Proficient with project management tools and techniques
•    Strong business acumen
•    Strong written/oral communication skills 
•    Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively
•    Ability to foster effective relationships and collaboration, motivate others, influence without authority

Qualifications: 
•    Requires a Bachelor's degree in Science, Engineering or a related field with at least 10+ years relevant industry experience in biopharma manufacturing/business; or Master's Degree in Science, Engineering, Business or a related field with 3-5+ years' relevant industry experience
•    A minimum of 3-5+ years project management experience as either a designated project manager or PM responsibilities as part of a technical role 
•    Working knowledge of small molecule process development, formulation development, analytical development, GMP manufacturing and quality control testing
•    Comprehensive project management skills. PMP certification is a plus
•    Experience working with CMC Teams and managing relationships with CMC vendors (CDMOs) is strongly preferred
•    Experience in a matrixed environment, effectively communicating cross functionally
•    Experience in a fast-paced, small company environment 
•    MS Project and MS Teams
•    Ability to accommodate flexible working hours to support business relationships in different time zones
•    Up to 10% domestic and international travel may be required