We are seeking a Senior Scientist with a strong technical background in Biologics and ADC process development to join our Manufacturing Sciences and Technology (MST) team. This position will have a dual role in the company and a wide range of input to support product development and cGMP manufacturing. Initially the position will be external facing and be the PD SME driving technical discussions with External CMOs as we drive multiple antibody and ADC candidates to IND. Later, and as dictated by company needs, the incumbent will work to establish in-house PD capabilities as part of a broader MST team.
For our currently outsourced development candidates, the PD SME will partner with external CMO technical teams, leverage your knowledge to identify and implement process improvements to optimize the manufacturing process and trouble shoot and mitigate operational bottlenecks. Design and execute experiments to generate supporting data for these improvements and analyze experimental data and generate documentation to support quality sections of multiple INDs.
- Have a broad knowledge in biologics and ADC process development pertinent to development, transfer and cGMP manufacture.
- Apply knowledge across each purification process module to optimize the overall process based on CQA’a.
- PhD in relevant engineering or scientific discipline with 5+ years of direct industry development experience.
- Deep knowledge and hands on experience with development and cGMP purification process.
- Strong oral and written communication skills; experience with GMP operations, technical reports, and specifications.
- Build a trusting relationship with CMO teams and be recognized as important team lead.
- Coordinate cross-functionally with internal and external groups to drive efficient and scalable processes.
- Serve as a key SME during scaleup, transfer, manufacture and any investigations to resolve issues that may be due to process related causes.
- Evaluate all aspects pertaining to or having impact on Manufacturing.
- Ability to influence cross-functionally in a matrix environment.
- Experience with data analysis tools, OTFAT, DOE, and statistical analysis.
- A strong appreciation of current good manufacturing practices (cGMPs).
Please send resume to email@example.com