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Quality Control Senior Analyst II

Company: bluebird bio
Location: Cambridge
Posted on: September 14, 2020

Job Description:

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek a QC Senior Analyst to support newly established commercial-level GMP testing laboratories for release and stability for multiple stages of our gene therapy products. This includes performing analytical methods, data review and trending, supporting continuous improvement of GMP systems to ensure a compliant Quality Control lab. The candidate will interface with Analytical Development and Method Validation ensuring successful method transfer, Quality Assurance, IT, Facilities, and other cross-functional teams as required. A cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role.

About the role:

• Perform cGMP analytical testing (bioassay, flow cytometry, qPCR, HPLC, and ELISA)

• Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.

• Author, review, and/or approve SOPs/policies and technical reports with general guidance

• Lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required

• Lead, author, perform, and/or review equipment validations with minimal guidance.

• Implement, lead and/or support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)

• Execute phase-appropriate test method validation protocols as needed

• Participate in providing the necessary information for regulatory filings and inspections.

• Lead and support CAPA/Continuous Improvement Initiatives

• Flexible to work off-set hours, if needed

About you:

• BS with 7+ years or MS with 6+ years in a biotechnology discipline

• 6+ years of experience in a cGMP/GxP environment is preferred

• Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC methods

• Demonstrate a strong initiative and scientific leadership

• Direct experience in authoring and review/approval of SOPs

• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude

• A passion for addressing the critical unmet medical needs of patients

• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment

• Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

Will you now or in the future require bluebird bio to commence (“sponsor”) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?  *

Point of Data Transfer - GDPR  *

Your privacy is important to us. bluebird bio, Inc. will use the information provided on this form to evaluate you for the position you are applying for and stay in contact with you for recruiting and hiring purposes. Please take a moment to read the Data Privacy Consent  located here and provide consent to the collection, processing, and notification of your rights regarding your personal information below. For more general information on how we will use, store, and protect the personal information provided through this form and on the website, please read our privacy policy located  here .

Read the Data Privacy Consent and select "I accept" to agree to the collection and processing of your personal information.

U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, 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 Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of 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 Disability Why 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 .

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Missing limbs or partially missing limbs

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Keywords: bluebird bio, Cambridge , Quality Control Senior Analyst II, Other , Cambridge, Massachusetts

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