Confidential is hiring: Vice President of Chemistry, Manufacturing & Controls (C

Vice President of Chemistry, Manufacturing & Controls (CMC)

About the Company

Thriving biotech company developing innovative treatments for muscle-related diseases

Industry
Biotechnology

Type
Public Company

Founded
1998

Employees
501-1000

Specialties

• heart failure
• amyotrophic lateral sclerosis
• spinal muscular atrophy
• hypertrophic cardiomyopathy
• and hypertrophic cardiomyopathy

Business Classifications

• B2B
• SAAS

About the Role

The Company is seeking a Vice President of Chemistry, Manufacturing, and Controls (CMC) to lead the transition from a clinical-stage to a commercial-stage organization. The successful candidate will be responsible for developing and executing a sustainable CMC strategy to support the development and commercialization of the company's pipeline assets. This executive will oversee all CMC functions, including drug substance, drug product, and analytical sciences, and will be tasked with leading a high-performing CMC organization. Key responsibilities include providing strategic direction for CMC activities, ensuring regulatory compliance, and managing CMC-related risks. The role demands a leader with a strong technical foundation, exceptional communication and leadership skills, and a strategic mindset with operational agility. Applicants for the VP of CMC role at the company should have a minimum of 20 years' experience in CMC and technical operations, with a focus on small molecule drug development. The ideal candidate will have a proven track record of leading CMC efforts from preclinical development to commercial launch, as well as direct experience with U.S. and European regulatory agencies. A collaborative and motivational leadership style is essential, as is the ability to manage broad responsibilities and engage cross-functional stakeholders. The role requires a candidate with a deep technical, operational, regulatory, strategic, and quality expertise, and a strong knowledge of cGMP, ICH guidelines, and global regulatory expectations. The VP of CMC will be a critical member of the executive team, with regular exposure to the C-suite, and will play a pivotal role in the company's mission to improve the lives of patients.

Hiring Manager Title
SVP of Global Supply Chain & Technical Operations

Travel Percent
Less than 10%

Functions

• Engineering