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Biomanufacturing Senior Specialist - Production (Molecular Medicine)

Company: Mayo Clinic
Location: Rochester
Posted on: January 25, 2023

Job Description:

Why Mayo ClinicMayo Clinic is the nation's best hospital (U.S. News & World Report, 2022-2023) and ranked #1 in more specialties than any other care provider. We have a vast array of opportunities ranging from Nursing, Clinical, to Finance, IT, Administrative, Research and Support Services to name a few. Across all locations, youll find career opportunities that support diversity, equity and inclusion. At Mayo Clinic, we invest in you with opportunities for growth and development and our benefits and compensation package are highly competitive. We invite you to be a part of our team where youll discover a culture of teamwork, professionalism, mutual respect, and most importantly, a life-changing career!Mayo Clinic offers a variety of employee benefits. For additional information please visit Mayo Clinic Benefits (https://jobs.mayoclinic.org/benefits/) . Eligibility may vary.Position descriptionThe Biomanufacturing Senior Specialist supports the development and production of biotherapeutics 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 contributing to CGMP development and manufacturing teams during the planning and execution phases of activities as well as maintaining the strict adherence to the development of approved CGMP-compliant manufacturing SOPs.QualificationsMinimum requirement of a bachelor's degree in a biomedical related field (e.g. biology, cell/molecular, bioengineering, laboratory medicine, etc.) and 7 years relevant experience in a complex research and/or manufacturing environment, or a Masters degree and 4 years relevant experience in a complex research and/or manufacturing environment, or a Ph.D. and 2 years relevant experience in a complex research and/or manufacturing environment. Experience or familiarity with a cGMP environment, manufacturing clinical-grade human cells, biologics, biomaterial, or other product intended for human use is advantageous.Additional qualificationsMust have strong experience in developing and observing SOPs. Ability to effectively communicate complex ideas to a variety of shareholders across functions through multiple forms of communication. An understanding of the application of laws, regulations, and guidance documents related to FDA regulated industries (biologics, pharmaceuticals, devices, etc.) is preferred. Exceptional human relations and communication (written, verbal, and listening) skills are required. 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 judgment while working under deadlines is required. Must be flexible with work schedule as needed to meet internal and external customer needs.Position opening is for a Biomanufacturing Sr Specialist for the Viral Vector Production Laboratory (VVPL). The candidate will be responsible for performing 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 develop and perform 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, and follow VVPL standard operating procedures. Additional tasks include maintenance and troubleshooting of lab equipment and the cleanroom facility.Physical activity routinely requires lifting and moving materials and equipment of 20 - 30 pounds. cGMP production processes are performed in a cleanroom laboratory and require wearing personal protective equipment including an environmental suit.The successful candidate must have extensive, advanced experience in cell culture procedures. Candidates with experience in virological techniques, large-scale culture and/or purification processes (particularly for AAV and Lentiviral vectors), processes using GMP, and development of written standard operating procedures 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 work collaboratively within a team.Position requires ability to pass aseptic processing qualification within 6 months of starting job, and to maintain this qualification.Exemption statusExemptCompensation Detail$72,945- $109,449 / yearBenefits eligibleYesScheduleFull TimeHours / Pay period80Schedule detailsM - F Day hours, additional as needed.Weekend scheduleOccasional weekend hours, as needed.International AssignmentNoSite descriptionMayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.RecruiterMatthew BurdickEOEAs 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.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.Equal opportunityAs 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.

Keywords: Mayo Clinic, Rochester , Biomanufacturing Senior Specialist - Production (Molecular Medicine), Healthcare , Rochester, Minnesota

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