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
Click
here to apply!
|