AMVETS Jobs

Why Mayo Clinic

Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans (https://jobs.mayoclinic.org/benefits/) – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.

Responsibilities

The Biomanufacturing Specialist Lead is the primary process development and/or manufacturing expert supporting the production of regenerative products via approved standard operating procedures (SOPs) and product validation for FDA-regulated, CGMP manufacturing operations. Primary responsibilities include meeting product integrity and quality produced for internal and external clients. Scope of the position includes effectively leading CGMP-related development and manufacturing teams during the planning and execution phases of activities as well as monitoring the strict adherence to approved CGMP-compliant development and manufacturing SOPs by staff.

Qualifications

Minimum requirement of a bachelor's degree in a biomedical related field (e.g. biology, cell/molecular, bioengineering, laboratory medicine, etc.) and 10 years relevant experience in a complex research and/or manufacturing environment, or a Masters degree and 6 years relevant experience in a complex research and/or manufacturing environment, or a Ph.D. and 4 years relevant experience in a complex research and/or manufacturing environment. Experience in a cGMP environment manufacturing clinical-grade human cells, biologics, biomaterial, or other product intended for human use is preferred.

Additional Qualifications:

Must have strong experience in developing and observing SOPs and track record of leveraging this experience to develop, qualify, and launch innovation. Products manufacture experience in both Upstream/Front End and Product manufacture/Qualification. Experience coaching others in biological products manufacture. Strong collaboration skills and experience partnering with other functions to deliver results. Ability to effectively communicate complex ideas to a variety of stakeholders across functions through multiple forms of communication, including formal presentation skills. An understanding of the application of laws, regulations, and guidance documents related to FDA regulated industries (biologics, pharmaceuticals, devices, etc.). Exceptional human relations and communication (written, verbal, and listening) skills are required. Organizational project management skills are essential, along with analytical and critical thinking abilities. Must be flexible and capable of adapting to and facilitating change. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgement while working under deadlines is required. Must be flexible with work schedule as needed to meet internal and external customer needs. Must be self-motivated and able to independently schedule workday activities with minimal direction.

Position opening is for a Biomanufacturing Specialist Lead in the Viral Vector Production Laboratory (VVPL). This Biomanufacturing Specialist Lead will be responsible for managing manufacturing operations, including process development, pre-clinical production processes, and GMP processes for a variety of viral vectors and cell lines. The candidate will be expected to work independently and in teams to perform, supervise, and develop viral production processes, adapt processes to comply with current Good Manufacturing Practices (cGMPs); manufacture products using cGMPs for use in human clinical trials; develop and perform experimental studies and quality control assays for viral products; and develop, write, review and follow VVPL standard operating procedures.

The successful candidate must have extensive, advanced experience in cell culture procedures. Candidates must have experience in virological techniques, large-scale culture and/or purification processes (particularly for AAV and Lentiviral vectors), processes using GMP, AND/OR development of written standard operating procedures. Candidates who meet more than one of the above criteria are preferred. This position requires attention to detail and meticulous record keeping and documentation. This position also requires excellent interpersonal skills and the ability to lead and motivate biomanufacturing team.

Physical activity routinely requires lifting and moving materials and equipment of 20 - 30 pounds. GMP production processes are performed in a cleanroom laboratory and require wearing personal protective equipment including an environmental sui

Exemption Status

Exempt

Compensation Detail

$82,097 - $123,219 / year

Benefits Eligible

Yes

Schedule

Full Time

Hours/Pay Period

80

Schedule Details

M-F Day hours, additional as needed.

Weekend Schedule

Occasional weekend hours, as needed.

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

Matt Burdick

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.