Executive Director, Biologics Drug Product

Disc Medicine

309d

About The Position

As Disc Medicine evolves from a clinical-stage to a commercial-stage organization, the Company has a new role for an Executive Director (ED) of Biologics Drug Products (BDP). The successful candidate will be instrumental in driving the company's growth trajectory and achieving strategic objectives. The ED of BDP will be responsible for providing leadership over all drug product activities across the biologics programs at Disc Medicine, focusing on antibodies. This role will encompass biologics formulation development and sterile drug product process development. There will be a significant contribution, and leadership is expected from this role to enable regulatory filings of Disc Medicine assets.

Requirements

• B.S. degree is required. Advanced scientific degree Ph.D. in a related field is highly preferred
• 15+ years of operations experience in the pharmaceutical/biopharmaceutical industry with a minimum of 12 years of leadership experience in leading antibody drug product development teams
• Demonstrated broad knowledge in sterile drug product development, technology transfer, and manufacturing
• Prior experience in formulation development of antibody products through various stages of the product lifecycle, including first in human and commercial formulations
• Experience in IND and BLA filings is highly preferred
• Strong ability to communicate well with cross-functional groups, including Drug Substance, Analytical Development, Quality, Regulatory, and Program Management
• Demonstrated ability in managing a department and associated budget
• Substantial experience working in CMC teams - with CMC leaders and related team leaders. Preferred to have experience as a CMC leader
• Strong network and prior experience with antibody drug product CDMOs
• Ability to provide excellent leadership to develop high-performing teams, including exceptional communication and one-team spirit
• Excellent collaboration and interpersonal skills; Ability to convey complex ideas succinctly
• 20-30% travel required

Responsibilities

• Lead the drug product function for biologics programs at Disc Medicine
• Oversee drug product manufacturing at contract development and manufacturing organizations (CDMO)s
• Lead commercial formulation development for antibodies
• Engage in selecting appropriate external providers, including formulation and fill/finish process development
• Provide expertise in various areas of biologics drug product, such as in-use compatibility studies
• As appropriate, engage in drug product transfer from one site to another
• Provide leadership in performing successful drug product process performance qualifications
• Manage a team of individuals and build the function that is poised for growth along with the rest of the company
• Form effective relationships and collaborate well with the CMC leader and CMC functions, including drug substance, analytical development, quality control, supply chain, and quality and regulatory organizations
• Responsible for budget management
• Engage with Executive Leadership as appropriate to proactively identify technical risks and provide scientific recommendations for mitigation
• Foster a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement

Benefits

• Comprehensive benefits
• Competitive compensation packages
• Flexible work environment

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree