Develop analytical methods internally, with hands-on UPLC and LC-MS work, including characterization of process impurities and degradation products.
Transfer methods to external partners.
Oversee outsourced analytical and QC activities, including method development, validation, release testing, stability monitoring, OOS/OOT investigations, and data package review.
Support identity testing for critical raw materials, including method selection, vendor coordination, data review, and targeted in-house analytical work.
Support formulation development by using analytical data to evaluate solubility, dissolution, stability, and provide analytical support to discovery and preclinical programs.
Author and review analytical sections of Module 3 submissions, covering methods, specifications, validation, stability and control strategy.
Partner with the CMC lead and quality team, and manage external CDMOs and CROs.
- Support bioanalytical development work for future generations of the compound.
- You might thrive in this role if you:
- Have a MS or PhD in analytical chemistry, medicinal chemistry, pharmaceutical sciences, or a related field, with 7+ years relevant industry experience in small-molecule analytical development, including experience in a regulated GxP environment.
Understand phase-appropriate analytical control strategy, including specifications, stability strategy, impurity control, reference standards, method validation, and regulatory documentation.
Have experience developing, validating, transferring, and overseeing analytical methods for drug substance and drug product release, stability, dissolution, and impurity testing.
Have experience working with CDMOs, CROs, or external laboratories to manage analytical development, validation, release testing, stability testing, investigations, and data review.
Bring hands-on expertise with UPLC/HPLC and LC-MS method development, troubleshooting, and data interpretation for small molecule assay, purity, impurities, degradation products, and related substances.
- Can operate independently in a lean environment, prioritize across internal hands-on work and external partner oversight, and communicate analytical recommendations clearly to cross-functional partners.
- It’s a bonus if you:
- Have run LC-MS/MS for drugs and metabolites in complex biological matrices.
Have experience contributing to or reviewing analytical sections of CTD Module 3 submissions; direct authoring experience is preferred.
Have worked on extractables and leachables, container closure, or device compatibility studies.
Have supported discovery or preclinical programs with analytical data to accelerate progression decisions.
