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Senior Manager, Quality Control

Company: bluebird bio
Location: Cambridge
Posted on: February 25, 2021

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

  • Lead a team to manage a multi-product portfolio in a stability program for ancillary materials, starting materials and drug products in support of our early, late-phase clinical, and future commercial development
  • Review and approve ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for ancillary materials, starting materials and clinical drug product
  • Utilize statistical software to trend stability data and establish retest and expiration dates
  • Oversee cross-functional laboratory investigations related to stability and laboratory operations
  • Collaborate with Quality management and CTOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
  • Prepare, review and/or approve CMC stability sections for clinical regulatory filings, MAA, and BLA
  • Manage timelines to meet department and corporate goals WHAT YOU'LL BRING You're the bird we're looking for if you:
    • Bachelor's or Master's degree in a scientific discipline, 10-15 years of related experience in QC GMP environment, and at least 5 years managing direct reports
    • Strong knowledge of cGMP/ICH/FDA/EU stability regulations
    • Solid understanding of statistical analysis as it relates to product stability trending and establishment of shelf life
    • Experience and strong understanding of statistical software packages such as JMP
    • Superb communications-both written and oral skills and "do-what-it-takes" attitude
    • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
    • Excellent organizational skills, ability to navigate and be successful in fast-paced and highly-matrixed work environment with changing priorities
    • Experience with CTO/CMO management and strong interpersonal skills with the ability to motivate others, influence, and negotiate challenging situations
    • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself. bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth. bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics. 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 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:
      • 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, Cambridge , Senior Manager, Quality Control, Executive , Cambridge, Massachusetts

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