Senior Scientist, Biologics

Role Summary

This role provides technical and analytical expertise for late phase and commercial biologics process development and clinical manufacturing activities for a specific technology area such as cell banking, cell culture, purification, formulation, or bioconjugation, ensuring manufacturing processes are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for managing tasks, activities, and projects at external CDMO partners, as well as contributing to internal cross-functional collaborations to develop and execute process development studies, clinical manufacturing, and validation activities. The Senior Scientist, Biologics should be comfortable communicating with cross-functional teams in formal settings and third-party meetings, be very knowledgeable in their focus technology area, and manage their own workload to complete assignments with some feedback from colleagues and/or their manager.

Responsibilities

• Designing and documenting development projects for a specific technology area (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) ensuring the appropriate process knowledge, technology transfer, analytical method transfer, design space and/or control strategy definition, optimization, and/or validation to produce clinical and/or commercial drug substance.
• Authors, reviews, and approves external manufacturing operation documents such as SOPs, batch records, protocols, and reports for a specific technology area (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) to produce clinical and/or commercial drug substance.
• Ensures appropriate compliance of a specific technology area (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.
• Authors and/or reviews source documents and CMC content related to a specific technology area (e.g. cell culture, purification, formulation, or bioconjugation) to support IND, NDA, BLA and similar regulatory agency applications.
• Independently collaborate with external partners such as CDMOs to assess capabilities, coordinate activities, troubleshoot and analyze operational performance, conduct risk assessments, and ensure timely deliverables.

Qualifications

• Science or engineering degree with minimum relevant experience as applicable: BS with 8 years of experience, MS with 6 years of experience, PhD with 5 years of experience.
• Minimum 5 years of experience in GMP, quality management system, and CMC compliance and regulation.
• Demonstrated understanding and application of project management principles and tools.
• Ability to work in cross-functional, virtual teams.
• Travel expectation: 10 – 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments.

Skills

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills