Associate Director, CMC Project Manager

POSITION OVERVIEW:

As Disc Medicine evolves from a clinical stage to commercial stage organization, the Company has a new role for an Associate Director, CMC Project Manager . The successful candidate will be instrumental in driving the company’s growth trajectory and achieving strategic objectives.

The successful candidate will support technical teams and manage associated projects both in house and at CDMOs. They will have a strong understanding of the functional operations of Chemistry, Manufacturing, and Controls with a focus on the operational aspects of CMC. Priority will be given to candidates with direct experience in CMC projects working with Contract Development and Manufacturing Organizations (CDMOs) especially on manufacturing oversight, as well as candidates who have direct experience in coordinating CMC teams.

RESPONSIBILITIES:

• Monitor financial approval cadence closely and coordinate budget management within teams
• Build relationships with key-decision makers in finance and SMEs
• Work closely with internal teams including CMC leader and CMC functions including Drug Substance, Drug Product, Supply Chain, as well as Quality and Regulatory organizations for small molecules/biologics
• In collaboration with technical leads, develop and manage risk mitigated CMC development strategies and project plans
• Coordinate CMC team meetings coordinating with CMC leads, 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 but not limited to contract review and negotiation, timeline management, and quarterly business review meetings.
• Collaborate with finance to forecast and manage the budget and quarterly accrual for all tech ops activities
• Support tech ops with Request for Proposal, contracts, POs and invoice approvals.

 REQUIREMENTS:

• Bachelors degree is required in Science, Engineering or related field with at least 10+ years relevant industry experience in biopharma
• A minimum of 3-5+ years CMC project management experience as designated project manager or PM responsibilities as part of a technical role, specific to CMC teams
• Working knowledge of small molecules and biologics process development, analytical development, GMP manufacturing and quality control testing
• PMP certification is a plus
• Ability to accommodate flexible working hours to support business relationships in different time zones
• Approximately 10-25% travel may be required