Allucent

VP CMC, Senior Strategist CMC – Contractor

Allucent

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Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • - 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

Requirements

  • - 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
  • **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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC strategyregulatory submissionsprocess developmentscale-upmanufacturing validationanalytical method developmentpackaging evaluationQuality by DesigncGMP standardsrisk-based strategies
Soft Skills
critical thinkinganalytical skillsfinancial acumeninfluencing teamsrisk assessmentproblem solvingdecision makingstrong communication skillsemotional intelligencecustomer focused leadership
Certifications
B.S.R.Ph.M.S.Ph.D.