Senior Specialist II, Tech Support & Sample Support
About The Position
The QC Program Management Technical Support (TT) and Sample Support (SS) Senior Specialist II provides technical leadership by managing QC Sample Plans, QC Specifications, stability protocols and reports, stability sample-pull scheduling, and stability specifications in collaboration with stakeholders and customers. The role supports timely completion of project milestones and deliverables, GMP-compliant laboratory operations, and participation in audits and inspections. As a QC representative, the specialist works with customers to scope QC Sample Plans, QC Specifications, and stability studies, and leads or participates in cross-functional collaborations. The position supports technology transfers of new customer projects involving QC Sample Plans, stability studies, and drug substance (DS) and drug product (DP) specifications. It authors and reviews controlled GMP documents and change controls, drives continuous improvement, identifies and resolves quality or process compliance gaps, supports training and regulatory activities, and works with LIMS and IT teams to develop sample-plan, specification, and stability functions. The role also provides guidance and feedback for QC personnel development.
Requirements
- Bachelor's degree in a listed or related science field and 5+ years of experience; or a master's degree in a listed science field and 3+ years of related experience; or a Ph.D. in a listed science field and 0+ years of related experience.
- 5+ years of project management experience.
- 1–3 years of experience in a GMP environment.
- 2–3 years of stability study management and protocol issuance experience.
- Experience working with customers and with technology transfers.
Nice To Haves
- 5+ years of project management experience in biotechnology, pharmaceutical, CRO, or CLO settings.
- Experience with Customer Relationship Management.
- Drug substance or manufacturing experience, including process validation, transfer, commercialization, manufacturing support, and troubleshooting.
- Experience using quality systems, such as deviation management, change control, CAPA, or document management systems.
Responsibilities
- Collaborate with customers and stakeholders in QC, Drug Substance Manufacturing, and Drug Product fill/finish to support technology transfers involving QC Sample Plans, stability studies, and DS/DP specifications.
- Author, review, and lead updates to controlled GMP documents related to QC Sample Plans, QC Specifications, stability protocols and reports, and stability specifications.
- Lead, author, and review change controls for QC Sample Plans and stability protocols, coordinating with stakeholders and communicating with customers as applicable.
- Manage and direct continuous improvement of QC Sample Plans and QC Specifications.
- Identify and resolve technical compliance gaps and quality or process improvement needs, leading solutions through completion and sustainable implementation.
- Lead or participate in team compliance activities, including writing, changing, and maintaining GMP documents with relevant stakeholders and QA.
- Ensure compliance with platforms, procedures, and the global QC vision.
- Support management with training compliance and inspections.
- Support regulatory requests, audits, and inspections.
- Collaborate with the LIMS team and IT department to develop DS/DP sample-plan, specification, and stability functions that meet end-user and customer requirements.
- Provide guidance and feedback for QC personnel development.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
