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Director Quality Control

Company: bluebird bio
Location: Durham
Posted on: September 13, 2020

Job Description:

Durham, North Carolina, United States of America

Join bluebird bio's enthusiastic and collaborative Quality team to contribute to the overall success of our novel gene therapy. As a key member of bluebird's new North Carolina manufacturing facility, the Director, Quality Control is responsible for providing strong leadership, strategic planning, technical expertise, and laboratory system oversight. The QC Director is responsible for laboratory operations over raw materials, in-process and release testing, environmental monitoring, and stability studies. This position requires strong knowledge of cGMP/ICH/FDA/EU, will help to author QC sections of relevant regulatory submissions and defend the overall QC strategy during site inspection.

About the role:

- Ensure cGMP compliance in all aspects of laboratory functions including the sampling of raw materials, maintaining Raw Material Specifications, testing of in process, release, stability samples and environmental of low bioburden and aseptic manufacturing clean rooms

- Assure a state of continuous inspection readiness

- A member of the Site Leadership Team

- Oversee the development of departmental budgets for QC, including defining materials, instruments and personnel needs

- Serve as an SME for analytical methodologies, raw material and product specifications, stability studies, and reference standards

- Author and approve QC sections of relevant regulatory submissions and product quality reviews

- Oversee laboratory investigations and excursions, change controls, and Deviation / CAPSs for QC operations

Manage and mentor QC staff, emphasizing the bluebird bio culture, teamwork, planning, follow-up and effective communication

- Collaborate with Cambridge site for QC method validation and in-house technical transfer activities

- Write and review QC SOPs, analytical test methods, protocols and reports

- Oversee instrument maintenance and calibration, along with laboratory maintenance

- Provide long-term planning of QC lab capabilities and capacity, including implementation of new technologies into the laboratory

- Ensures adherence to current FDA regulations, ICH, and applicable foreign regulations

About You:

- A degree in pertinent life sciences, or equivalent, with 15+ years' relevant industry experience

- Experience with analytical test methods optimization, validation, and transfers

- Ability to define problems, collect data, analyze and establish facts, draw conclusions and assess technical data for compliance and recommended solutions to complex problems related to quality control issues

- Strong technical knowledge and skill base in biological/microbiological science

- Strong knowledge of cGMP/ICH/FDA/EMA regulations

- Prior experience in the QC of vector or gene therapy field is a plus

- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view

- Independently motivated, detail oriented and good problem solving ability

- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-passed environment

-Excellent communications skills and ability to influence across multiple functions

- be ready to embrace the principles of the bluebird bio culture at this new facility: 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 .

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:

Autism

Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS

Blind or low vision

Cancer

Cardiovascular or heart disease

Celiac disease

Cerebral palsy

Deaf or hard of hearing

Depression or anxiety

Diabetes

Epilepsy

Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome

Intellectual disability

Missing limbs or partially missing limbs

Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)

Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

Disability Status 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: bluebird bio, Durham , Director Quality Control, Other , Durham, North Carolina

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