VP CMC/Senior Strategist CMC (Contractor) at Allucent – Cary, North Carolina

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Vice President of Chemistry, Manufacturing, and Controls (VP CMC) contractor to join our A-team (hybrid*/remote). As a VP CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products.

About the role

As the VP CMC, you are the subject matter expert who will work cross-functionally and globally with internal team members and external clients. You will:

• Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch
• Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines
• Oversee critical development activities including process development, scale-up, manufacturing validation, analytical method development, and packaging/labeling evaluation
• Manage cross-functional collaboration as a Subject Matter Expert and Technical Lead, partnering with internal teams and external manufacturing partners (CDMOs/CMOs) to ensure seamless program execution
• Champion quality and compliance by implementing Quality by Design principles, cGMP standards, and risk-based strategies that support clinical trials, regulatory approvals, and commercial success
• Build and mentor high-performing teams while managing budgets and timelines to deliver robust, scalable, and cost-effective pharmaceutical solutions

This role is open to considering candidates from United States, Canada, Countries within the EU, and United Kingdom.

• Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development

• Advanced scientific and regulatory knowledge of drug, biologic, or device development
• >15 years’ post-degree of directly relevant experience in drug, biologic, or device development preferred

Skills:

• Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English
• Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
• Quality focus
• Strong emotional intelligence, customer focused leadership and decision-making skills
• Innovative, creative, and practical thinking including problem-solving skills

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program

Disclaimers:

*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-Remote #LI-Hybrid #LI-TCW