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REGENXBIO · 1 week ago

Senior Associate Scientist/Scientist, Bioanalytical Sciences

Rockville, MD

Full-time

Onsite

Mid, Senior Level

$104K/yr - $141K/yr

1+ years exp

REGENXBIO is an exceptional place to work, offering opportunities to collaborate with leading experts in gene therapy. The Scientist role involves developing and validating bioanalytical methods to support the company's gene therapy pipeline, ensuring compliance with regulatory standards and promoting innovation in analytical techniques.

BiopharmaBiotechnologyGeneticsTherapeutics

Responsibilities

Develops, qualifies and/or validates robust bioanalytical methods per Health Authority Guidance Documents using biochemical technique (qPCR, ddPCR, ligand binding assays) to support the Company pipeline

Promotes innovation and direct operational improvement and/or evaluation of new analytical techniques or technology

Troubleshoots and resolves bioanalytical method issues to successful resolution

Takes accountability and demonstrates responsibility regarding scientific study conduct

Ensures analytical development/validation activities conducted internally and with contracted services lead to robust methods that support bioanalytical analysis

Conducts technology transfer between research organization, in-house and contract laboratories

Writes and reviews study protocols, analytical procedure, reports for regulatory submissions

Performs technical reviews of analytical data and be responsible for data interpretation, analysis, and reporting of results for method development and validation

Provides scientific and technical input to the study team and other departments

Ensures that any circumstances that may affect the quality and integrity of the study are identified and documented as they occur and that appropriate corrective actions are taken

Identifies process improvement opportunities, participates in execution of initiatives

Coordinates parallel tasks across multiple projects and plans, prioritizes, and manages duties to meet departmental and organizational goals

Mentors and/or trains new and less-experienced employees and develops training materials and schedules

Reviews and participates in writing of departmental Standard Operating Procedures (SOPs)

Performs additional tasks or assist with special projects as assigned or needed

The Scientist will be required to maintain familiarity with scientific literature and apply it appropriately to projects (such as evaluating new methodologies and techniques)

Qualification

Bioanalytical methods developmentPCR techniques qPCRPCR techniques ddPCRFDA bioanalytical guidanceAssay validation dPCRAssay validation LBAAssay validation LC-MS/MSStatistical toolsSoftwareTechnical writing skillsProblem-solving abilitiesTeam-orientedCross-functional collaboration

Required

PhD in relevant scientific discipline with 1+ years of industry or post-doctoral experience or Master's degree in relevant scientific discipline with 5+ years of relevant experience

Solid understanding of polymerase chain reaction (PCR) including both qPCR and ddPCR, experience using commercially available PCR machine, and ability to design primers/probes sets

Strong knowledge of FDA and global bioanalytical assay guidance

Skilled in independently designing and executing experiments to meet project goals

Experienced in developing and validating assays (dPCR, qPCR, LBA, LC-MS/MS) and performing advanced data analysis

Proficient in interpreting results, troubleshooting, and recommending next steps

Effective communicator with strong presentation and technical writing skills

Capable of leading cross-functional and external collaborations

Team-oriented with proven problem-solving abilities

Proficient in statistical tools and software (SoftMax, MS Office)