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Associate Director, Quality Control - Stability/Operations

Company: Lever
Location: Cambridge
Posted on: September 14, 2020

Job Description:

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.

Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives.

Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include remote based web-ex video discussions, interviews & onboarding. Associate Director, Quality Control - Stability/Operations

Woburn, MA /

Ultragenyx - Gene Therapy - Quality /

Full-time

Apply for this job

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.

Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives.

Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include remote based web-ex video discussions, interviews & onboarding.

Position Summary

Reporting to the Director of Quality Control, the Associate Director-Stability /Operations will support the UGT portfolio of clinical development programs to ensure timely delivery of clinical supplies. This position will lead the UGT Stability programs and support QC Operations for the sample logistic function and data management for Quality control both internally and externally managed CRO's.

Responsibilities

*

Stability Operations

* Define strategy for UGT stability programs

* Oversight and responsibility for the UGT QC stability programs

* Collaborate with CMC teams for stability inputs for programs

*

* Collaborate with QC stakeholders for plasmid stability strategy and execution

* Execute stability programs including authoring/approving stability protocols and reports

* Prepare, analyze and trend QC stability data

* Support CMC stability sections of Heath authority submissions

* Responsible for QC stability SOPs

* Support HA inspections and responses

* Change controls and quality records for area of responsibility QC Operations

* Support the expansion of QC operation function and teams

* Oversight of QC laboratory data; internal and external

* Business owner for QC ELN and LIMS systems

* Oversight for QC batch Certificate of Analysis and reference standard programs

Requirements

* BS or MS in Biochemistry, Biology, Chemistry or related discipline with 7+ years relevant industry experience

* SME in stability programs including knowledge and understanding of relevant regulatory requirements

* Excellent technical writing skills

* Experience in management of direct reports (3-5 years)

* Experience in data management and lab informatic systems

* Demonstrated ability to lead strategically and implement systems and solutions

* Ability to work on multiple priorities within cross functional teams

* Experience drafting protocols, data reports and QC/QA compliance documents required

* Ability and desire to work in a fast-paced, start-up environment

* Strong collaboration, team-working skills and communication skills

* Independently motivated and detail-oriented with good problem solving ability

#LI-CZ1

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

Apply for this job * BS or MS in Biochemistry, Biology, Chemistry or related discipline with 7+ years relevant industry experience

* SME in stability programs including knowledge and understanding of relevant regulatory requirements

* Excellent technical writing skills

* Experience in management of direct reports (3-5 years)

* Experience in data management and lab informatic systems

* Demonstrated ability to lead strategically and implement systems and solutions

* Ability to work on multiple priorities within cross functional teams

* Experience drafting protocols, data reports and QC/QA compliance documents required

* Ability and desire to work in a fast-paced, start-up environment

* Strong collaboration, team-working skills and communication skills

* Independently motivated and detail-oriented with good problem solving ability Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

Keywords: Lever, Cambridge , Associate Director, Quality Control - Stability/Operations, Other , Cambridge, Massachusetts

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