Senior Manager, Quality Control
Company: bluebird bio
Location: Cambridge
Posted on: February 25, 2021
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Job Description:
On January 11, 2021, we announced our intent to separate our
severe genetic disease and oncology businesses into differentiated
and independent publicly traded companies. We will retain focus on
severe genetic disease (SGD) and will launch our oncology business
("Oncology Newco") as a new entity, with the completed transition
expected by the end of 2021. ABOUT THE NEST At bluebird, only two
things matter - patients and our people. When you join the nest,
you're not just landing a new gig, you become a part of a flock
that's soaring to new heights. We're 1100+ doers, thinkers and
collaborators across the globe with a strong sense of our values
and our purpose. Our innovation and sustainability are rooted in
the diversity of our teams and results are achieved through
cooperation and the incorporation of multiple points of view. This
is personal and we approach every challenge with radical care. The
time is now to rise up and recode the science, the systems, and the
status quo. ABOUT THE FLOCK Join bluebird bio's enthusiastic and
collaborative team and contribute to the overall success of our
novel gene therapy approach. This is an exciting hands-on
leadership role within our Quality Control stability team at Senior
Manager level. We seek an experienced Quality Control professional
to lead activities associated with QC strategic management of
stability programs for ancillary materials, starting materials and
drug products in support of our early and late-phase clinical
development to ensure successful clinical and commercial regulatory
filings in the EU and US. You will provide significant contribution
to the daily operations of the Quality Control laboratories as well
as strategies for future growth and improvements. This position
requires partnering with various internal laboratory operations as
well as a Contract Testing Organizations (CTO) network. The
position requires a strong knowledge of cGMP/ICH/FDA/EU
regulations.
HOW YOU'LL FLY
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(Completion is voluntary) Individuals seeking employment at
bluebird bio are considered without regards to race, color,
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physical or mental disability, veteran status, gender identity, or
sexual orientation. You are being given the opportunity to provide
the following information in order to help us comply with federal
and state Equal Employment Opportunity/Affirmative Action record
keeping, reporting, and other legal requirements. Completion of the
form is entirely voluntary. Whatever your decision, it will not be
considered in the hiring process or thereafter. Any information
that you do provide will be recorded and maintained in a
confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity
Definitions If you believe you belong to any of the categories of
protected veterans listed below, please indicate by making the
appropriate selection. As a government contractor subject to
Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we
request this information in order to measure the effectiveness of
the outreach and positive recruitment efforts we undertake pursuant
to VEVRAA. Classification of protected categories is as follows: A
"disabled veteran" is one of the following: a veteran of the U.S.
military, ground, naval or air service who is entitled to
compensation (or who but for the receipt of military retired pay
would be entitled to compensation) under laws administered by the
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released from active duty because of a service-connected
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the three-year period beginning on the date of such veteran's
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Defense. An "Armed forces service medal veteran" means a veteran
who, while serving on active duty in the U.S. military, ground,
naval or air service, participated in a United States military
operation for which an Armed Forces service medal was awarded
pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB
Control Number 1250-0005 Expires 05/31/2023 Voluntary
Self-Identification of DisabilityWhy are you being asked to
complete this form? We are a federal contractor or subcontractor
required by law to provide equal employment opportunity to
qualified people with disabilities. We are also required to measure
our progress toward having at least 7% of our workforce be
individuals with disabilities. To do this, we must ask applicants
and employees if they have a disability or have ever had a
disability. Because a person may become disabled at any time, we
ask all of our employees to update their information at least every
five years. Identifying yourself as an individual with a disability
is voluntary, and we hope that you will choose to do so. Your
answer will be maintained confidentially and not be seen by
selecting officials or anyone else involved in making personnel
decisions. Completing the form will not negatively impact you in
any way, regardless of whether you have self-identified in the
past. For more information about this form or the equal employment
obligations of federal contractors under Section 503 of the
Rehabilitation Act, visit the U.S. Department of Labor's Office of
Federal Contract Compliance Programs (OFCCP) website at
www.dol.gov/ofccp . How do you know if you have a disability? You
are considered to have a disability if you have a physical or
mental impairment or medical condition that substantially limits a
major life activity, or if you have a history or record of such an
impairment or medical condition. Disabilities include, but are not
limited to:
Keywords: bluebird bio, Cambridge , Senior Manager, Quality Control, Executive , Cambridge, Massachusetts
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