Sr. Research Scientist I (Associate Director), Process Development
- Lead CMC development work of pipeline programs for Phase I clinical and up to commercial processes.
- Direct large molecule candidate selection and advance upstream First-In-Human (FIH) platform, and encompass the aspects of process development, optimization, characterization, validation, tech transfer to manufacturing, and regulatory filings.
- Lead efforts on the development and implementation of new technologies and business strategies to improve process capabilities and drive operational efficiency. Drive cell culture and bioreactor development and champion creative process improvement initiatives. Participate in laboratory bench work as needed.
- Oversee project plans, including raw materials and equipment availability, in preparation of laboratory and/or pilot-scale runs from the team.
- Design and execute studies and interpret experimental results. Make strategic recommendations to the team/management on project related issues (e.g., study design, progress, priorities, resourcing, future strategies).
- Write and review SOP, technical summary, and development reports for efficient knowledge management.
- Participate in authoring CMC regulatory filing sections.
- Keep current in relevant literatures/patents and related new technologies with a track record of successful applications of said technologies that comply to current and emerging regulatory requirements (e.g., FDA, EMA, ICH). Foster a culture of innovation and an environment of technical mastery at all levels.
- Pursue fundamental, scientific, and mechanistic understanding as needed, including collaborating with academia, CMO/CDMO, vendors, or regulatory agencies.
- Author patents, peer-reviewed publications, and presentations for scientific and technological developments, as well as being expected to exert influence internally and externally.
- Manage a team of scientists/engineers with different levels of expertise.
- Serve as a technical lead by providing technical oversight to the team and training to junior scientists.
- Build a high performing team. Set SMART goals and directions to the team. Be able to effectively mentor, engage, and develop direct reports. Inspire trust, respect, and collaboration, with prior experience as a people manger.
- Ensure that safe laboratory practices are followed.
- Carries out direct supervisory responsibilities in accordance with the departmental set goals.
- Responsibilities include interviewing potential employees, employee training and development, planning, assigning, and directing work, appraising performance, rewarding and disciplining, corrective action and complaint resolution.
Required Education, Knowledge & Skills
- PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Cell Biology, Biochemistry, or related scientific fields/disciplines with 8+ years, MS with 12+ years, or BS with 15+ years of relevant experience in the biotech or biopharmaceutical industry. Title will be dependent on candidate's experience/qualifications.
- Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products
- Extensive experience with (pre-)pivotal phase process development. Expertise in scale-down model qualification, risk assessment (FMEAs), process characterization and validation (PCPV), tech transfer and process scale-up, and/or regulatory filings.
- Extensive expertise in cell culture, fed-batch process, and/or perfusion (e.g., ATF) technology development in controlled bioreactors with a variety of systems including bench-scale reactors and high throughput technologies (e.g., ambr).
- Good understanding of Chinese Hamster Ovaries (CHO) cell biology, metabolic pathways, cell culture media, and engineering principles (mass transfer, mixing, shear, etc.) for bioreactor scale-up.
- Working knowledge of design of experiments (DOE), in-depth understanding of statistical analysis, and interpretation of cell culture data using statistical software (e.g., JMP, Design Expert, MiniTab) or statistical toolboxes of Matlab, etc.
- Excellent communication and presentation skills. Proven track record of accomplishments (scientific publications and/or presentations) in upstream process, media development, or technology development areas.
- Strategic and innovative thinker with track record of fresh insightful thinking by developing creative approaches to processes/practices and implementation of new technologies
- Self-motivated individual with a "can do" attitude coupled with a willingness to do what it takes to achieve team goals and overcome whatever project obstacles occur. Superior problem-solving skills in anticipating issues, identifying root causes of critical process deviations, and recommending effective/ efficient technical solutions to the team.
- Strong organizational skills to manage projects (or work) in a matrix environment. Comfortable working with minimal directions/guidance. Abilities to work strategically in a detail-oriented framework, react productively to changes in priorities, and handle other essential tasks well as assigned.
- Experience in all aspects of late-stage process development activities, along with control strategy, is highly preferred.
- Strong understanding of processes, equipment, and facilities involved and extensive hands-on experience with bench-top bioreactors (e.g., applikon vessels coupled with finesse controllers) is preferred.
- Hands on experience with high-throughput microreactor systems (e.g., ambr250 or Dasgip) is desirable.
- Experience with perfusion (e.g., ATF) cell culture or continuous manufacturing is preferred.
- Working knowledge of advanced in situ analytics for process monitoring and control (e.g., Raman spectroscopy) is desirable.
- Experience with the operation and troubleshooting of single-use bioreactor (SUB) systems and scale-up (e.g., 50L, 200L) is beneficial.
- Experience in application of Quality by Design (QbD) principles as appropriate for late stage programs and jointly development of suitable control strategy for commercial process are advantageous.
- Understanding of the evolving regulatory requirements and experience in authoring IND/BLA sections and interaction with regulatory agencies is highly desirable.
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