Small Molecule Drug Substance Lead

About the role

You will lead small molecule drug substance activities from lab development through clinical and commercial manufacturing readiness. You will work closely with teams in process development, quality, regulatory, manufacturing and supply. We value practical scientific judgment, clear communication, and collaborative leadership. This role offers visible ownership, career growth, and the chance to make a meaningful impact by helping deliver safe, reliable medicines.

Responsibilities

• Lead the drug substance workstream for small molecule programs, guiding process development, scale-up, and technology transfer.
• Build and maintain integrated development plans, milestones and decision points that support program timelines and regulatory expectations.
• Design and execute experiments for process characterization, robustness studies, and scale-up risk mitigation.
• Coordinate cross-functional teams and external partners to resolve technical issues and secure clinical and commercial supply readiness.
• Prepare clear technical summaries, risk assessments, and recommendations for project leadership and governance.
• Mentor colleagues, share practical knowledge, and promote inclusive ways of working.

Key working relationships

• Collaborate with CMC, analytical development, quality, regulatory affairs, clinical supply, manufacturing, and external contract organizations.
• Engage suppliers, contract manufacturers and external labs to align technical approaches and timelines.
• Present program status, risks and mitigation plans to project teams and decision forums.

Basic Qualification

• Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, or related field.
• Minimum 10 years industry experience in small molecule drug substance process development, scale-up, or CMC roles.
• Practical experience in technology transfer to manufacturing sites or CMOs.
• Knowledge of process design, process characterization concepts and control strategy development.
• Proven ability to lead cross-functional workstreams in a matrixed environment.

Preferred Qualification

• Clear written and verbal communication skills for diverse technical and business audiences.
• Advanced degree (MS or PhD) in chemistry, chemical engineering, or pharmaceutical sciences.
• Experience in late-stage development, regulatory submissions or supporting regulatory interactions.
• Experience with high-potency compounds, specialized handling, or complex purification processes.
• Formal project management training or experience managing multi-site transfers.
• Track record of mentoring or leading small technical teams.
• Familiarity with quality systems, risk management, and data integrity principles.

Working model

This role is hybrid in the United States. Expect regular on-site work combined with focused remote time. On-site presence is required for lab, manufacturing or key team activities.

What We Value In You

• You put patient impact and safety at the center of your decisions.
• You communicate clearly and make practical, evidence-based recommendations.
• You build collaborative relationships and work with humility.
• You learn from experience and share knowledge to raise team capability.
• You demonstrate inclusive behavior and support a culture of inclusion.

Pay

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $149,325 to $248,875. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.

Benefits

• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays, vacation, and paid caregiver/parental and medical leave