We are looking for a Sr. Director, CMC to join our A-team (hybrid*/remote) in the USA. As a Sr. 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. Director, CMC, 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 with a focus on scientific aspects.
- Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
- Prepare product development plans from early development through Phase 4.
- Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
- Perform other scientist related duties, as needed.
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
- Experience in pre-approval products; large biologics experience required.
- Line management experience required.
- Prior CRO experience preferred.
Skills:- Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, 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
- >10 years' post-degree of directly relevant experience in drug, biologic, or device development desirable
BenefitsBenefits 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.
#LI-Remote #LI-TCW
