Scientist I, CMC Process Development

The Position
A Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase process development and regulatory filings.

Responsibilities:
- Oversee and perform experiments for late phase process development of API and regulated materials, including process improvement, impurity identification, and fate and purge studies
- Analyze and interpret experimental technical data
- Work with internal and external teams to manage the determination, supply, and specifications of materials for late phase drug substance programs
- Maintain knowledge of process and project history as well as process development and regulatory issues
- Collaborate with Regulatory Affairs in the preparation of regulatory documents (CTAs, IMPDs, NDAs, and MAAs)
- Make oral presentations to scientists and management
- Guide, mentor and develop chemists across the team
- Support talent acquisition efforts
- Identify growth opportunities for team members
- Work closely with other department members
- Recommend new ideas, synthetic routes, and technologies to support departmental goals

Requirements:
- Master’s Degree in Chemistry with at least 5 years work experience, or Bachelor’s Degree in Chemistry with at least 8 years equivalent industry work experience
- Excellent verbal and written communication skills
- Excellent problem-solving skills
- Knowledge in synthetic chemistry and analytical technology; hands-on experience in syntheses and development of small and large molecule drug candidates

Preferred:
- Strong track record of scientific publication
- Prior experience with cGMP manufacturing and pharmaceutical regulatory compliance
- Prior experience working with or within CDMOs

Benefits:
- Competitive salaries and an excellent benefit package

Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.