Development Scientist III, Analytical Development and Clinical QC

This is what you will do:

External Testing Oversight: Lead and manage end-to-end for all outsourced testing (release, stability, in-process and impurity), including assay troubleshooting, to meet program milestone deliverables. Ensure testing complies with GMP, GxP and data integrity principles (ALCOA+) enabling audit/inspection readiness.

Laboratory Investigations (LIR): Lead and manage authoring and/or mirroring of Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results with structured root cause analysis, impact assessment, corrective/preventive actions (CAPA) and effective timely closure in quality system. Lead cross-functional meetings with quality assurance to ensure structured investigation alignment.

Test Protocols with Sample and Data Flow Control: Manage established processes and own review/approval of release/stability and PPQ testing protocols as well as sample logistics and electronic record upload to quality system.

Analytical Method Lifecycle Support: Manage and facilitate review and approval of analytical methods, including but not limited to identification of gaps, review and approval of change control and/or updates to associated validation/transfer reports in conjunction with the validation team.

• High attention to detail and ability to maintain accuracy in documentation and processes. Excellent analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.
• A broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Strong proficiency in quality management systems and effective communication skills for interacting with cross-functional teams.
• Strong proficiency with MS Word, Excel, PowerPoint.
• Ability to bend, reach and stand, with lifting up to 15 pounds and carry over short distances.
• Ability to travel up to 10%, if needed.
• Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline with 6-10 years (Ph.D.) or 15+ (M.S.) hands on biological analytical development experience in pharmaceutical industry.

• Experience of managing CLO/CMO.
• Strong understanding of cGMP quality and regulatory requirements for CMC biologics with regulatory authoring experience.
• Database management / statistical analysis (e.g., JMP, Tableau, SAS) with proficiency in Microsoft SharePoint and/or BOX.

The annual base pay (or hourly rate of compensation) for this position ranges from $ - $ USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.