Position Summary:

Scientists/Senior Scientists within Analytical Development contribute significantly to the operation and growth of BIB. The role is for a highly motivated individual who will work independently or as a supervisor/project lead. Responsibilities involve developing analytical methods for biologics characterization, characterizing samples from process development, supporting subsequent clinical and/or commercial GMP manufacturing, and mentoring junior scientists or associates.

Responsibilities:

1. Provide technical expertise and leadership in the characterization of samples from upstream and downstream process groups, analyzing and documenting data, and achieving goals for cross functional development teams.
2. Develop and apply HPLC methods (including RP, SEC, IEX etc.) for biologics process development and support purposes. Additionally, develop and apply other common analytical methods such as electrophoresis, Western-Blot, ELISA, PCR, endotoxin and host cell proteins detection, concentration determination, and possibly cell-based assays.
3. Operate, supervise, and troubleshoot analytical instruments to ensure consistency and reliability. Maintain accurate experimental records and results in laboratory notebooks and/or datasheets. Provide training and appropriate supervision to junior scientists or associates on analytical development, characterization of samples, and interpretation of data.
4. Analyze and interpret experimental data and present/document experimental results. Provide reports and prepare scientific presentations as needed. Deliver conclusions and recommendations to internal teams and external clients. Author SOPs, protocols, and technical reports and ensure adherence to high technical standards and compliance with applicable regulatory guidelines. Contribute to process/technology transfer (externally from client or internally to Manufacturing) and provide manufacturing support and troubleshooting.
5. Maintain awareness of relevant scientific literature and new technologies. Participate in/lead the evaluations of new technologies and their potential applications and business impacts. Provide technical expertise and leadership in innovative efforts of project teams. Maintain substantial knowledge of state-of-the art principles and theories and contribute to the knowledge base through literature reviews, conference attendances, and publications.
6. Ensure and promote safe environmental and laboratory practices.

Qualifications:

1. PhD./Master’s/Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or a related/relevant discipline or demonstrated coursework in such areas. Additionally, hands-on experience with biologics/protein analytics in the biopharmaceutical industry. (Knowledge of AAV and mRNA analysis and characterization a plus.)
2. Ph.D. with ≥0 years (≥5 years for Sr. Scientist) or Master’s with ≥3 years (≥8 years for Sr. Scientist) or Bachelor’s with ≥6 years (≥10 years for Sr. Scientist) of industry experience in analytical method development and qualification of biologics molecules, characterization and data analysis/interpretation, and analytical tech transfer to cGMP manufacturing facilities in biotechnology, pharmaceutical, or related environments.
3. Knowledge/experience of cGMP working environments.
4. Strong technical, organizational, and communication skills, as well as a good ability to develop creative solutions to challenging problems.
5. Strong ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and demands.
6. Proactive attitude to learn new technologies and manage changes in process development and process scale-up.
7. Strong teamwork/collaboration spirit and good ability to communicate appropriately and effectively.
8. Client focused, results oriented, and science and innovation driven with good financial awareness.
9. Advanced written skills.
10. Attention to detail, and the ability to multitask.
11. Proficient with the use of MS Office software (MS Excel, MS Word, MS Powerpoint) and statistical DOE software including JMP, Minitab, Design Expert etc.
12. Flexible and results oriented.