Vice President, CMC & Technical Operations

The Company:

Newleos Therapeutics is a clinical stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development. Newleos’ clinical-stage pipeline was in-licensed from Roche and includes multiple oral small molecules targeting novel mechanisms across a broad range of indications, including generalized anxiety, social anxiety, substance use disorders, and cognitive impairment.

Position Overview:

Reporting directly to the SVP of Clinical & Technical Operations, the VP of CMC and Tech Ops will be a key member of the leadership team responsible for building and executing the Chemistry, Manufacturing, and Controls (CMC) strategy, as well as overseeing technical operations for our neuroscience pipeline. The ideal candidate will bring deep technical expertise, strategic foresight, and a builder’s mindset to help us scale from preclinical to clinical development.

This position is based in Back Bay, reports to the Sr. Vice President, Clinical and Technical Operations, and supports a weekly hybrid work schedule with 3 days (Mon, Tues, Wed) in office and 2 days (Thurs & Fri) remote.

Responsibilities:

CMC Strategy & Leadership

• Develop and lead the overall CMC roadmap across preclinical and early clinical development stages.
• Provide strategic guidance on formulation, analytical development, process development, and manufacturing approaches tailored to CNS drug delivery challenges.
• Author and review CMC sections of regulatory submissions (INDs, IMPDs), ensuring scientific rigor and regulatory compliance.

Technical Operations Oversight

• Manage all aspects of drug substance and drug product development, from process design to clinical trial material production.
• Oversee technical transfers, scale-up, and manufacturing readiness to support Phase 1/2 trials.
• Ensure seamless integration of technical activities across internal teams and external partners.

Vendor & CDMO Management

• Identify, select, and manage contract development and manufacturing organizations (CDMOs), CROs, testing labs, and supply chain vendors.
• Establish robust contracts, quality agreements, and KPIs to ensure performance, compliance, and cost-effectiveness.
• Maintain close communication with external partners to monitor timelines, troubleshoot issues, and ensure deliverables.

Cross-Functional Collaboration & Leadership

• Collaborate with Medical, Regulatory, Clinical Operations, and Quality to ensure CMC alignment with clinical and business objectives.
• Serve as a technical leader and internal subject matter expert for CMC-related topics in cross-functional discussions.
• Build, lead, and grow a small, agile CMC and technical operations function suitable for a lean biotech environment.

Quality & Compliance

• Partner with Quality Assurance to ensure GMP compliance of manufacturing and testing activities.
• Support audit readiness and resolution of CMC-related observations or deviations.

Qualifications:

• Education
  • PhD, MS, or equivalent in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• Experience
  • 15 years of industry experience, including 5 years in a leadership role overseeing CMC and Technical Operations, preferably in early-stage biotech.
  • Strong background in small molecule or CNS drug development
  • Demonstrated success managing CDMOs and global vendors to support preclinical and clinical supply.
  • Deep understanding of regulatory expectations (FDA, EMA) for early-stage filings, including IMPD, IND, CTA preparation.
  • Demonstrated general ability applying fundamental scientific and engineering know how for crafting innovative and practical solutions to technical challenges
  • Demonstrated ability creating and executing strategies for successful product development through effective management of CMOs/CTOs resources
  • Substantial experience with cGMP manufacturing and testing of pharmaceuticals from early through advanced clinical development; ability to manage and simultaneously advance multiple tasks/projects and pivot in strategy and operational execution
  • Knowledge of cGMP regulations and CMC-relevant ICH guidance documents as well as experience in the preparation and defense of CMC regulatory documents
  • Skilled in clearly conveying complex concepts and study results in written and verbal form to a range of audiences, such as peers, executive management, regulatory agencies, and intellectual property attorneys
  • Highly motivated, ethical and professional self-starter with strong interpersonal skills and a quality and sense of urgency mindset, who is capable of influence and negotiation with stakeholders to successfully prosecute the completion of projects per timeline
  • Demonstrated, motivational leadership leading technical teams within a highly matrixed environment; ability to articulate vision and successfully drive execution

Newleos Therapeutics is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.