Sr. Scientist, Analytical Development - California, United States - Enigma Search

Description

Summary

Searching for a Sr. Scientist in Analytical Development. This individual will be a lead at company's Technical Development department, executing against and supporting oversight of the analytical functions (method development, qualification, routine testing, and new technology evaluation) that are integral to the successful development and manufacturing of cell and gene therapy products for new or existing clients. The scientist will also support activities required for GMP readiness (qualification protocol and report writing, qualification planning and strategy and method lifecycle management).

Responsibilities

• Execute development, optimization and troubleshooting of analytical methods for cell and gene therapy products, ensuring technical excellence.
• Execute routine testing activities, including in-process recoveries, stability studies, and cell line characterization.
• Evaluate new and innovative technologies for implementation into QC.
• Partner with MSAT on process characterization and control strategies.
• Lead assay transfer to quality control team, including writing SOPs and training QC analysts.
• Take a lead role in assay qualification activities, including partnering with QC, planning qualifications, data analysis and interpretation.
• Write qualification protocols and qualification reports in accordance to regulatory guidelines.
• Implement statistical tools and design of experiments (DOE) to ensure robustness and reliability of assays.
• Provide technical expertise and support for investigations and troubleshooting activities.
• Represent GeneFab in analytical SME-to-SME meetings with current and prospective clients as well as in internal meetings.
• Collaborate with cross-functional teams, including scientists, engineers, and quality to support project success and timelines.
• Ensure compliance with process operations which interact with Good Manufacturing Practices (GMP) and regulatory guidelines.
• Foster a culture of scientific excellence and mentor team members.
• Stay current with industry trends and emerging technologies in cell and gene therapy analytics.

Requirements

• Ph.D. in a relevant scientific discipline (e.g., Biochemistry, Molecular Biology).
• A minimum of 2 years of relevant experience in analytical development and testing in the cell and gene therapy field.
• Experience managing or leading teams in a mentor/lead capacity and/or as a manager/supervisor
• Proficiency in a broad range of analytical techniques used in cell and gene therapies (qPCR/dPCR, Flow Cytometry, ELISA, HPLC)
• Extensive flow cytometry experience is strongly preferred.
• Strong communication and project management skills, with a commitment to cross functional collaboration.
• Knowledge of cGMP and regulatory guidelines (e.g., FDA, EMA) and a track record of ensuring compliance in analytical operations.
• Experience driving assay qualifications and validations.
• Good understanding of ICH guidelines for assay qualification/validation.
• Basic understanding of method lifecycle management from development to validation and beyond.
• Ability to analyze and interpret data and contextualize with the program goals and requirements in a phase-appropriate manner.

Salary and Benefits

• The base salary range for this role is $115,000 - $160,000; starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity.
• We offer an excellent benefits program including a selection of Medical, Dental and Vision plans, FSA, HSA, Company paid holidays, employee assistance program, commuter benefits, wellbeing resources, perks and more
• Significant growth opportunity as the company expands.

Compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications, and the position's requirements.

Enigma Search Solutions is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment.