Sr. Manager/Associate Director, CMC Development
Frontier Medicines
- Boston, MA
- $140,000-185,000 per year
- Permanent
- Full-time
- Managing daily pre-formulation/material assessments of API and preclinical formulations
- Fostering collaboration with CMC and Discovery R&D teams
- Conducting development studies, interpreting results, and suggesting follow-up actions independently
- Overseeing drug substance process development and manufacturing
- Coordinating drug substance program management
- Engaging with CROs/CDMOs and identifying new technologies
- Ensuring comparability assessments and cultivating vendor relationships
- Supervising third-party activities and delivering project updates with recommendations
- PhD. in Pharmaceutical Chemistry, Materials Science, Medicinal Chemistry with 5+ years, MSc. with 8+ years, or BS with 10+ years of experience in small molecule drug substances and drug products
- Project Management experience considered advantageous
- Proven ability to work independently, multitask effectively, and manage a diverse range of projects simultaneously.
- Experience with quality by design (QbD), process validations and statistical design of experiments (DOE) is preferred
- Experience with early through late-stage process development is strongly preferred
- Team player who will be able to collaborate effectively in a cross-functional matrix team environment including Safety Assessment and DMPK groups
- Exceptional oral communication and writing skills
- A thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required
- Ability to travel domestically and/or internationally to achieve goals, when required
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Free Food & Snacks
- Wellness Resources
- Stock Option Plan