We are looking for an Associate Director, Chemistry Manufacturing and Controls (CMC) to join our A-team. The specific experience for CMC is small molecule (solid, liquid, oral, topical, injectable (sterile products), inhalation. We are mainly focused on pre-approval products.
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
- Scientific and regulatory knowledge of drug, biologic, or device development
- Critical thinking and analytical skills, as well as strong written and verbal communication skills in English
- Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
- Quality focus
- Emotional intelligence 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
- Relevant work experience in a CRO environment, specific experience with small molecule (solid, liquid, oral, topical, injectable (sterile products), inhalation.
- Ability to author eCTD CMC Module 3.0 focused on pre-approval products
Benefits
- 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 enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees