VP, Chemistry, Manufacturing & Controls (CMC) - Starting Material & API

VP, Chemistry, Manufacturing & Controls (CMC) - Starting Material & API

Join to apply for the VP, Chemistry, Manufacturing & Controls (CMC) - Starting Material & API role at Sionna Therapeutics

VP, Chemistry, Manufacturing & Controls (CMC) - Starting Material & API

Join to apply for the VP, Chemistry, Manufacturing & Controls (CMC) - Starting Material & API role at Sionna Therapeutics

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Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.

Position Summary:

We are seeking an accomplished and visionary Vice President of Chemistry, Manufacturing & Controls (CMC) to lead all aspects of starting material and API strategy, development, and manufacturing for our small molecule pipeline. This executive will provide technical leadership, strategic foresight, and enterprise-level thinking across the lifecycle of drug development — from candidate nomination through commercialization. The successful candidate will bring a demonstrated ability to balance technical execution with strategic thinking and operate as a player/coach. Willingness and ability to travel (both domestic and international) to manage and audit partner CDMOs is required. This role reports to the SVP, CMC.

Responsibilities:

Strategic and Enterprise Leadership

• Own the end-to-end CMC strategy for starting materials and APIs, ensuring alignment with clinical, regulatory, commercial, and corporate objectives.
• Develop strategic options for sourcing, process development, and tech transfer, optimizing for cost, quality, and risk.
• Anticipate and mitigate supply chain and technical risks through proactive planning, vendor selection and dual sourcing.
• Serve as a thought partner across R&D, Quality, Regulatory, and Commercial to integrate CMC considerations into broader enterprise decisions.
• Provide updates to Senior Leadership and Board of Directors on CMC progress, risks, and strategic initiatives.
• Represent CMC on the Sionna Program team.

Technical Leadership and Execution

• Lead the design, development, scale-up, and validation of robust, efficient, and sustainable synthetic routes for clinical and commercial APIs.
• Guide process chemistry efforts with an emphasis on control strategies, regulatory readiness, and manufacturability.
• Guide process chemistry efforts to develop novel routes that reduce Cost-of-Goods and increase convergency for Sionna small molecules.
• Develop regulatory starting materials for Sionna small molecules.
• Drive innovation in synthetic chemistry and manufacturing technologies (e.g., continuous manufacturing, green chemistry).
• Partner with Quality Assurance to maintain quality system compliance (change control, controlled documentation, deviations, CAPA) and ensure product quality.
• lOversee CMC documentation and regulatory submissions (e.g., IND, IMPD, NDA/MAA) with a focus on starting materials and drug substance modules.

External Manufacturing and CDMO Strategy

• Build and manage a high-performing global external network for raw materials, intermediates, and APIs.
• Establish effective governance, technical oversight, and performance management of CDMOs.
• Ensure external partners meet technical, quality, and compliance expectations through strategic partnerships and tech transfer excellence.

Organizational Development and Team Leadership

• Recruit, mentor, develop, and lead CMC team members and create a high-performing, collaborative, and accountable culture with a focus on scientific rigor and enterprise value creation.
• Foster talent development and succession planning to scale with the needs of a growing pipeline and organization.
• Be a culture champion who lives Sionna values - intentional innovation, unwavering integrity, continuous collaboration, flexible first, and active trust.

Qualifications:

• Ph.D. in Organic Chemistry
• 15+ years of progressive experience in pharmaceutical development and manufacturing, with deep technical knowledge in process chemistry and API CMC.
• Proven track record in developing and scaling synthetic routes from early development through commercial launch.
• Expertise in global regulatory expectations related to starting materials, control strategies, and drug substance modules (e.g., ICHQ11, Q7).
• Experience managing CDMOs and global supply chains.
• Demonstrated ability to develop and execute flexible, risk-informed CMC strategies under uncertainty.
• Skilled in scenario planning and managing CMC trade-offs across cost, quality, speed, and risk.
• Strong leadership presence with the ability to influence across disciplines and senior levels.
• Excellent communication, collaboration, and executive stakeholder engagement skills.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science, Research, and Engineering

• Industries

  Biotechnology and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

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