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The job details are as follows:
Working collaboratively across Manufacturing, Quality Assurance, Quality Control, and external partners, the Senior Analytical Specialist plays a critical role in maintaining assay performance, supporting product release, investigating laboratory deviations, and ensuring adherence to GMP, regulatory, and company quality standards.
- Perform in-process and release testing of iPSC banks, including flow cytometry, qPCR, STR, endotoxin, and ELISA, independently
- Author and/or review protocols, summary reports, and SOPs for testing, validation, method transfers, equipment qualifications, equipment operation, and analytical test methods
- Participate in technology transfer, method qualification, and validation independently
- Coordinate testing activities with external contract laboratories, including sample shipment, method transfers, data review, and ensuring compliance with company standards and regulatory requirements
- Support installation/operation/qualification (IQ/OQ/PQ) of new equipment, including drafting/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; perform routine housekeeping of the laboratory space
- Lead and conduct routine investigations for out-of-specification (OOS) results/deviation investigations and CAPA implementation as needed
- Serve as 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
- All other duties as required
Minimum Requirements
- Bachelor’s Degree in biology, molecular biology, immunology, or related field
- 5+ years of relevant experience in analytical testing with a Bachelor's Degree or
- 3+ years of relevant experience in analytical testing with a Master's Degree
- Proficiency in performing lot release assays and cell characterization assays (i.e., flow cytometry, qPCR, STR, endotoxin, ELISA)
- Ability to independently troubleshoot assays
- Experience with Good Documentation Practices (GDP) record keeping, preferably in a cGMP environment
- Strong written and verbal communication skills to interact cross‑functionally and with management; ability to clearly summarize testing status and quality issues
- Detail‑oriented, organized, and self‑motivated with the ability to prioritize work in a dynamic environment; able to work independently and within a multi‑functional team
- Excellent interpersonal skills with the ability to communicate effectively and collaborate cross-functionally
Preferred Qualifications
- Master’s Degree in biology, molecular biology, immunology, or related field
- 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 (RCA and CAPA) execution in QC assays
- Knowledge and understanding of sterility, mycoplasma, and NGS assays
Job Location
United Therapeutics requires this role to be 100% onsite in our Silver Spring, MD office.
The salary range for this position is $92,500 - $122,500 per year and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
