DescriptionYour Role:The
Scientist, Downstream Process Development, will support the development and optimization of downstream purification processes for protein-based biologics. Responsibilities include chromatography and filtration process development, scale-up and technology transfer activities, viral clearance studies, and data analysis. The individual will collaborate closely with Upstream Process Development, Analytical Sciences, MSAT, Manufacturing, Program Management, and clients to advance development programs from early-stage development through manufacturing.
Key Responsibilities:
- Demonstrated expertise in downstream process development for monoclonal antibodies, recombinant proteins, and other biologic modalities, including chromatography, filtration, buffer development, and process scale-up.
- Strong understanding of protein purification principles, process characterization, experimental design, statistical data analysis, and biopharmaceutical development workflows.
- Experience leading technical projects, troubleshooting complex process challenges, and driving development strategies with minimal supervision.
- Demonstrated ability to analyze, interpret, and present scientific data, author technical reports, and communicate findings effectively to internal and external stakeholders.
- Experience supporting technology transfer, manufacturing process implementation, and cross-functional collaboration within a GMP-regulated environment is highly desirable.
- Knowledge of process analytical technologies (PAT), laboratory automation, high-throughput process development, process intensification, and digital data management tools is preferred.
- Proven ability to mentor junior scientists and provide scientific leadership across project teams.
- Excellent written and verbal communication skills, with experience interacting directly with clients, partners, and senior leadership.
- Working knowledge of regulatory expectations and CMC development activities supporting clinical and commercial biologics programs is desirable.
- Occasional travel by land and/or air may be required to attend seminars or conferences or client meetings.
Minimum Qualifications:- Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biological Sciences, or a related discipline with 0-3 years of relevant industry experience; OR M.S. degree with 5+ years; OR B.S. degree with 8+ years of relevant biopharmaceutical industry experience.
Preferred Qualifications: - Ph.D. in Biochemistry, Chemistry, or related field with 1-2 years or M.S. with 3-5 years of industry experience.
- Prior experience in leading downstream process development of biologics is a plus.
- Experience mentoring or leading scientific staff preferred.
Position Type/Expected Hours of Work:This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $124,000 - $155,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
