Your Role:

This position is primarily responsible for leading the analytical transfer used in the testing of cellular therapy products into Process Sciences. This position may serve as a process owner and may drive medium scope continuous improvement projects and Business Process Improvement activities related to overall department goals.

Essential Duties and Responsibilities:

• Liaison between PS and QC for analytics
• Support analytical transfer into PS, and into/out of QC
• Support stability program
• Participate in research and development activities
• Mentor junior employees
• Author and/or review and approve GMP documentation
• Author and/or review and approve protocols and reports
• Serve as process owner and drive medium scope CI projects
• Troubleshoot analytical issues, including investigation for root cause (OOS) and implementation of corrective and preventive action (CAPA) plans.
• Lead risk assessments, root cause analysis and similar activities

Requirements:

• Bachelor's or advanced degree from a four-year college or university in a biological or biomedical discipline. A minimum of 5-8 years progressive experience with clinical processing analytical testing in the cell therapy industry and/or cell culture operations in the biotechnology industry.
• Expert understanding of Immunoassays and quant and routine analytical methods, such as flow cytometry, Elisa and QPCR.
• Expert in one or more advanced methods, such as cytotoxicity and/or cytokine characterization.
• Advanced understanding of cGMP and regulations/guidance.
• Ability to interpret guidance documents and make technical recommendations.
• Strong technical writing and communication skills.
• Expert understanding of analytical transfer, qualification, and validation.
• Advanced understanding of statistical methods applicable to analytical transfer and qualification.
• 10-20% Domestic and International travel.

Technical Skills:

• Advanced Understanding of Quant and routine analytical methods. Familiar with 1 or more advanced methods.
• Advanced understanding of cGMP and regulations. Can read guidance documents and make technical recommendations.
• Sound technical writing.
• Advanced understanding of analytical transfer, qualification, and validation.
• Sound understanding in statistical methods

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $120,278 - $141,593/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.