About the Role
This role involves leading scientific and technical activities in process development for late-stage drug products, supporting commercialization and lifecycle management through process optimization and technology transfer.
Responsibilities
- Lead process development activities for late-stage drug product formulations
- Design and execute experiments to optimize manufacturing processes
- Support technology transfer to internal and external manufacturing sites
- Troubleshoot formulation and process-related issues
- Generate scientific data to support regulatory filings
- Collaborate with analytical development teams to define product specifications
- Evaluate process scalability and robustness
- Develop and refine manufacturing protocols
- Contribute to risk assessments and process validation strategies
- Interface with cross-functional teams including manufacturing and quality
- Provide scientific leadership during process investigations
- Ensure compliance with regulatory and safety standards
- Support deviation and CAPA investigations related to process performance
- Lead process characterization and process validation studies
- Mentor junior scientists and promote technical excellence
- Stay current with industry trends and emerging technologies
- Participate in project planning and timeline estimation
- Present data and findings to internal stakeholders
- Drive continuous improvement initiatives in process development
- Support lifecycle management strategies for commercial products
Nice to Have
- Experience in biologics or large molecule drug product development
- Background in aseptic processing and sterile manufacturing
- Knowledge of continuous manufacturing processes
- Experience with real-time release testing strategies
- Prior work in a global development environment
- Familiarity with regulatory agencies such as FDA or EMA
- Experience mentoring scientists in a matrix organization
- Exposure to automation and process analytical technology (PAT)
- Track record of publications or patents in relevant fields
- Experience with combination products or novel delivery systems
Compensation
Competitive salary and benefits package offered.
Work Arrangement
On-site position with limited remote flexibility based on project needs.
Team
Part of a multidisciplinary team focused on late-stage development within the drug product development organization.
Why Join Us
This role offers the opportunity to work on innovative therapies at a critical stage of development, contributing directly to patient impact. You will collaborate with global experts and leverage cutting-edge technologies in a science-driven environment focused on solving complex development challenges.
Equal Employment Opportunity
We are committed to equal opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status.
Visa sponsorship may be available for qualified candidates based on business needs.
