Scientist I
- Independently design, develop, and optimize robust analytical methods using separations-based techniques (HPLC, icIEF, CE-SDS) to characterize biopharmaceutical products
- Implement and innovate new experimental protocols/techniques.
- Understand the goal and maintain a high proficiency in his/her projects as well as the overall program.
- Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
- Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner.
- Perform routine and complex tasks competently and independently and generate reliable and consistent results.
- Troubleshoot complex analytical issues and implement innovative solutions to improve method performance and efficiency.
- Impact projects mostly through lab and/or pilot plant based activities.
- Responsible for compliance with all applicable Corporate and Divisional policies and procedures.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.
- Bachelors degree in Biochemistry, Bioengineering, or Pharmaceutical Sciences with 5 years of relevant experience or Master’s Degree in Biochemistry, Bioengineering, or Pharmaceutical Sciences or equivalent education with typically two years of experience.
- Theoretical and practical knowledge to carry out the job functions.
- Strong understanding of protein biochemistry and analytical method development principles.
- Experience in developing and optimizing methods for charge variant analysis, including both icIEF and CEX techniques, with the ability to transfer these methods to a QC environment.
- Proficiency in AKTA purification and fractionation to support comprehensive characterization workflows.
- Proficiency in operating and troubleshooting analytical instrumentation (e.g., Agilent, Waters HPLC systems, Maurice, PA800 systems).
- Experience with the qualification and validation of analytical methods in accordance with ICH, FDA, and USP guidelines, ensuring methods are suitable for late-phase development and regulatory submissions.
- Experience using automation to standardize high-throughput workflows.
- Familiarity with statistical tools for data analysis, Empower and regulatory guidelines.
- Experience collaborating with the process development, quality control, and regulatory affairs teams to align analytical strategies with project timelines and goals.
- Knowledge of AAV separation techniques and awareness of future advancements in the field.
- Capable of providing technical guidance and mentorship to junior scientists and laboratory staff.
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
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