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Responsibilities

This position within the Center of Regenerative Biotherapeutic’s Process Development team will be responsible for contributing to projects focused on the translation of innovative immune effector cell therapies, including CAR-T developed at Mayo Clinic and/or in collaboration with industry partners. Demonstrated experience with aseptic technique and cell culture required. Experience with immune cell identification, isolation and culture preferred.

Work unit process development engineer who under the guidance of the senior scientist, managers, and lead engineers contributes to the development, scale-up and optimization of novel/new biotherapeutics in preparation for cGMP compliant manufacturing operations. Optimization of process steps to target process scale for improvement of existing methods or implementation of novel technology of proven validity. Assists in drafting technical documentation such as study reports, standard operating procedures (SOPs), manufacturing batch records and associated records to support transition of biotherapeutics into clinical production and product validation for FDA-regulated, cGMP compliant manufacturing operation.

Responsibilities will include the execution of studies to support process optimization for clinical translation of novel biotherapeutics. Works with the process development engineers, scientists and project managers. Analysis, organization, and presentation of data in a clear and concise manner. Creation of batch documentation, maintenance of laboratory notebooks and preparation of protocols and reports in a compliant manner.

Assists in the development of release testing methods and the maturation of research analytical methodologies into development and cGMP processes. Facilitates analytical method technology transfer to and from our facilities and/or contract vendors. Executes laboratory studies, analyzes experimental data and carefully documents resultant information. Assists in training manufacturing personnel in final product manufacturing processes.

Qualifications

• Bachelor's degree in biotechnology, biological science, chemistry, immunology, cell/molecular biology, bioengineering or other related science from an accredited institution.

• 3-5 (Bachelor’s) or more years of related process development or laboratory experience within the biologics industry.

• Self-motivated, highly organized, efficient, and able to follow work orders with minimal supervision.

• Excellent written and verbal communication skills are necessary.

• Experienced in aseptic mammalian cell culture techniques and protocols.

• Familiarity with various culture methods such as 3D culture systems, bioreactors and closed systems, desired.

• Experienced in cell culture analyses such as cell viability evaluations, flow cytometry, immunocytochemistry, bright-field and confocal microscopy, spectrometry, and PCR.

• Demonstrated analytical and scientific competency with process development and/or validation of lab techniques or procedures.

• Assists in investigating alternative approaches for process optimization.

• Experience with data collection, organization, analysis and delivery of information.

Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.

Exemption Status

Exempt

Compensation Detail

$77K - $115K / year

Benefits Eligible

Yes

Schedule

Full Time

Hours/Pay Period

80

Schedule Details

M-F

Weekend Schedule

As needed per project

International Assignment

No

Site Description

Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. (https://jobs.mayoclinic.org/alllocations)

Affirmative Action and Equal Opportunity Employer

As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.

Recruiter

Kaela Peterson

Equal opportunity

As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.