Principal Scientist – Analytical Development, Tech Ops, Biologics
Oruka Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $175,000 - $230,000 per year
Job Level
Senior
About the role
- Lead external method development, optimization and qualification/validation efforts across liquid chromatography, capillary electrophoresis, spectrophotometric and bioassay (among others) for release and stability testing of clinical trial materials.
- Manage multiple non-GMP and GMP stability studies for drug substance (DS) and drug product (DP) batches for multiple programs.
- Leverage stability data to project shelf-life of both DS and DP supply through trending analysis.
- Develop strategies to establish characterization and comparability packages across various DS/DP lots.
- Support process and manufacturing teams towards implementation of relevant analytical methods.
- Work closely with cross-functional stakeholders (QA, Regulatory, Clinical Supply Chain) for shelf-life extension of clinical material to support ongoing clinical trials.
- Partner with internal and external stakeholders to justify and establish DS/DP protocols and specifications.
- Work with CDMO partners to perform root cause analysis and investigations to support OOS/OOT results that may arise during stability studies.
- Contribute to IND/BLA sections pertaining to analytical methods, stability studies, characterization and analytical comparability.
- Lead the diligence process to select clinical and commercial CDMO vendors.
- Partner with operations, legal, and finance groups to finalize confidentiality, master service and contractual agreements.
- 20-25% travel in support of diligence and campaign execution at the CDMOs.
Requirements
- Associate Director: Master’s (10+ years) or a PhD (6+ years) or Principal Scientist: Master’s (6+ years) or PhD (4+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC. Experience with monoclonal antibodies is a requirement.
- Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics.
- Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based)
- Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada, EU, etc.
- Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
- Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies.
- Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch.
- Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
- Must have a creative and strategic attitude with the ability to work in a fast-paced environment.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
- A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
liquid chromatographycapillary electrophoresisspectrophotometrybioassayU/HPLCELISAcell-based assaysmethod developmentqualificationvalidation
Soft skills
writingorganizationcommunicationpeople managementstrategic thinkingcreativitycollaborationproblem-solvingadaptabilitystakeholder engagement