3 дня назад
Senior Scientist I, Drug Product Development (Biologics)
96 500 - 183 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Scientist I, Drug Product Development (Biologics) (biologics formulation and process development): Designing and executing formulation, process development, characterization, and robustness studies for biologics drug products with an accent on scale-up, technology transfer, and scientific problem-solving. Focus on developing stabilization strategies, applying Design of Experiments and multivariate analysis, and supporting sterile manufacturing and CMC activities.
Location: North Chicago, Illinois, United States; onsite role
Salary: $96,500–$183,500 annual base pay
Company
develops medicines and solutions for serious health conditions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Lead biologics drug product formulation, process development, characterization, and robustness studies.
- Support scale-up and technology transfer to internal and external manufacturing sites.
- Collaborate with discovery research, analytical development, bioprocess development, combination products, science and technology, pilot plants, and third-party manufacturers.
- Represent Biologics Drug Product Development in cross-functional product presentation, device strategy, and CMC teams when needed.
- Communicate study plans, risks, and mitigation strategies to stakeholders and management.
- Support scientific initiatives that improve capabilities and business processes.
Requirements
- Bachelor’s degree with typically 10 years of experience, master’s degree with typically 8 years of experience, or PhD with 0+ years of industry experience.
- Proven ability to solve critical scientific problems.
- Hands-on experience with biologics formulation development.
- Experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
- Understanding of biologics degradation mechanisms and stabilization strategies.
- Hands-on experience with Design of Experiments, multivariate statistical analysis, and data visualization tools.
Nice to have
- Knowledge of relevant cGMP and regulatory guidance.
- Experience with sterile manufacturing operations, including freeze-thaw, mixing, filtration, filling, and lyophilization.
- Experience with scale-up, technology transfer, third-party manufacturers, quality risk management, and drug product control strategies.
Culture & Benefits
- Work within a global Biologics Drug Product Development organization in ’s R&D function.
- Paid time off, vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) benefits for eligible employees.
- Eligibility for short-term incentive programs.
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