Allucent
Sr. Director, CMC
Cary, North Carolina, United States · Director · Contract
Sponsorship not specifiedDetected 51 days ago
ExcelRecruitingPerformance ManagementClinical TrialsFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingMicrosoft OfficeSharePoint
About the role
- Director, CMC to join our A-team (hybrid*/remote) in the USA.
- Director, 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 Sr.
- Prepare product development plans from early development through Phase 4.
Responsibilities
- Lead end-to-end CMC strategy across drug substance, drug product, and analytical development-from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
- Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
- Perform other related duties, as needed.
Requirements
- Line management experience required.
Skills
- Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles.
- Candidates should never be submitted directly to our hiring managers, employees, or human resources." #LI-Remote #LI-TCW
- Benefits of working at Allucent include:
Benefits
- Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
Company info
- 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 Sr.
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