Associate Principal Scientist – Analytical R&D
| Company | Inventing for Life |
|---|---|
| Location | Durham, NC, USA |
| Salary | $139600 – $219700 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Mid Level, Senior |
Requirements
- Bachelor’s Degree (BA/BS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR
- Master’s Degree (MA/MS) with a concentration in sciences with four (4) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR
- PhD with a concentration in sciences with two (2) years of experience working in the field of analytical testing, development, transfer, and/or validation.
- Demonstrated experience with analytics for commercial vaccine and/or microbiological products.
- Effective communication and teamwork.
- Experience with large molecule GMP testing, including drug substance and drug product stability and release testing.
- Experience with analytical comparability.
- Experience leading a cross-functional team.
- Strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques.
Responsibilities
- Ensure execution of test methods is aligned and sustainable across multiple QC laboratories
- Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations.
- Responsible for assay monitoring ensuring method performance data are presented, discussed and actions developed at analytical working group meetings as appropriate.
- Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply of BCG
- Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between Company sites as well as and CMO/CROs
- Provide input into cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure life cycle management.
- Act as subject matter expert informing development and optimization of existing analytical methods to enable modernization of our testing strategies.
- Accountability for analytical method transfers and in-line assay method validations, including review of protocols and reports.
- Escalation of key assay challenges to management in a timely and concise manner.
- Partnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing.
- Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.
- Coordinate analytical issue resolution via subject matter experts within the global large molecule network.
- Support RTQs, PAI readiness and audit observations
Preferred Qualifications
- Continuous improvement or Project Management training.
- Writing or review of technical documents, preferably including regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA).
- Experience with large molecule analytical transfers.
- Experience with commercial product analytical method changes.
- Experience with assay monitoring and trending.