Senior Analytical Specialist, iPSC

United Therapeutics Corporation•Silver Spring, MD

7d•$92,500 - $122,500•Onsite

About The Position

The Senior Analytical Specialist, iPSC works collaboratively with Manufacturing, Quality Assurance, Quality Control, and external partners. The role maintains assay performance, supports product release, investigates laboratory deviations, and ensures adherence to GMP, regulatory, and company quality standards. The position is 100% onsite at United Therapeutics’ Silver Spring, Maryland office.

Requirements

Bachelor’s degree in biology, molecular biology, immunology, or a related field.
At least 5 years of relevant analytical testing experience with a bachelor’s degree, or at least 3 years with a master’s degree.
Proficiency performing lot-release and cell-characterization assays, including flow cytometry, qPCR, STR, endotoxin, and ELISA.
Ability to troubleshoot assays independently.
Experience with Good Documentation Practices (GDP) recordkeeping, preferably in a cGMP environment.
Strong written and verbal communication skills, including the ability to interact cross-functionally and with management and clearly summarize testing status and quality issues.
Detail-oriented, organized, and self-motivated, with the ability to prioritize in a dynamic environment and work independently and within a multifunctional team.
Excellent interpersonal skills and the ability to communicate and collaborate effectively across functions.

Nice To Haves

Master’s degree in biology, molecular biology, immunology, or a related field.
At least 2 years of experience in a GMP pharmaceutical laboratory.
Knowledge of cGMP requirements and QC laboratory practices.
Experience with method transfers, assay qualification, and validation.
Experience performing equipment qualification (IQ/OQ/PQ).
Familiarity with OOS/deviation investigation, including RCA and CAPA execution in QC assays.
Knowledge and understanding of sterility, mycoplasma, and NGS assays.

Responsibilities

Independently perform in-process and release testing of iPSC banks, including flow cytometry, qPCR, STR, endotoxin, and ELISA.
Author and/or review protocols, summary reports, and SOPs for testing, validation, method transfers, equipment qualifications and operation, and analytical test methods.
Independently participate in technology transfer, method qualification, and validation.
Coordinate testing with external contract laboratories, including sample shipment, method transfers, data review, and compliance with company standards and regulatory requirements.
Support installation, operation, and qualification (IQ/OQ/PQ) of new equipment by drafting or reviewing protocols, executing tests, and coordinating with contract vendors.
Ensure laboratory equipment is calibrated, maintained, and ready for use; troubleshoot instrumentation as needed.
Maintain laboratory inventory and supplies and perform routine laboratory housekeeping.
Lead and conduct routine out-of-specification (OOS) and deviation investigations, and implement CAPAs as needed.
Serve as the primary point of contact for routine testing status in manufacturing and project updates.
Train manufacturing operators on assay sample preparation and basic equipment handling.
Analyze, organize, and present data results in weekly meetings.
Perform other duties as required.