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Summary
About the Role
About You
- Degree in Biotechnology, Chemistry, Biochemistry, Biochemical/Chemical Engineering, or a related field.
- A minimum of 5 years of proven experience in the biotechnology or pharmaceutical industry, specifically focusing on CMC activities in biologics.
- Strong understanding of drug substance development, process development, and manufacturing.
- Demonstrated expertise in regulatory submissions and compliance with GMP, ICH, EMA, and FDA regulations.
- Excellent project management skills, with the ability to manage multiple projects simultaneously.
- Advanced degree in a relevant field.
- Experience with drug product manufacturing.
- Experience in late-stage clinical and commercial phases.
- Excellent communication and interpersonal skills.
- Ability to travel as needed for business purposes.
- Mandarin language is a plus.
Benefits
- Competitive salary range of $118.5k–$139.5k per year.
- Total compensation package may include bonus, stock, benefits, and/or other applicable variable compensation.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate. We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.