Director/Executive Director of Quality Control

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Senior Director/Executive Director of Quality Control - Gene Therapy Company: Lever

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Senior Director/Executive Director of Quality Control - GeneTherapy Ultragenyx is a commercial-stage biopharmaceutical companycommitted to developing novel therapies for the treatment of rareand ultra-rare genetic diseases. The company has rapidly built adiverse portfolio of small molecule, monoclonal antibody, mRNA andgene therapy candidates with the potential to address debilitatinggenetic diseases for which the unmet medical need is high, thebiology for treatment is clear, and for which there are typicallyno approved therapies treating the underlying disease.

With the company’s recent acquisition of Dimension Therapeutics,the Ultragenyx Gene Therapy division was established. TheUltragenyx Gene Therapy division is headquartered in Cambridge, MA.We are looking for exceptional individuals who share our passionfor developing novel therapies to treat rare diseases and advancingthe field of gene therapy.

Developing new treatments for rare genetic diseases ischallenging work. It takes courage, talent, and dedication to lookpast the easy answers and uncover new solutions that can make ameaningful impact. At Ultragenyx we push each other to perform atour very best, because we never lose sight of our mission – to makea difference in our patients’ lives.

Come join our team during this exciting time of growth andopportunities! During the COVID-19 Outbreak we are committed to ourhiring process. The health and safety of our employees andprospective employees take priority which means at this time ourprocess will include WebEx video discussions, interviews &onboarding.

Position Summary

The Senior/Executive Director of Quality Control will providemanagerial, technical, operational and strategic leadership in thedevelopment and implementation of all quality control and relatedactivities. This will include team leadership, Quality controlbusiness process build out, establishment of technical operations,methods transfer, feasibility assessment, qualification/validationand execution of multiple methods. The ideal candidate will overseespecification setting committee, support phase appropriate criticalquality attribute determination for all gene therapy assets, leadstability programs both in-house and at external contractlaboratories. The Senior/Executive Director will be a member of theQC senior leadership team, whereby contributing towards harmonizedQC operations for broad spectrum of therapeutic assets includingBiologics, small molecules and mRNA based therapeutic entities.This role will require full collaboration with analyticaldevelopment, manufacturing operations and Quality assurance, andCMC regulatory affairs teams. Fostering a quality and continuousimprovement mindset to ensure that all QC deliverables are cGMPcompliant in a phase appropriate fashion to support early and latephase clinical programs.

Responsibilities: Management and leadership of high performingQC functions, including Bioassay, Chemistry, Molecular Biology,Virology, Technical and operational teams.

Management of Methods validations, transfer, testing andinvestigations for multiple gene therapy assets. This includesassessment and evaluation for QC fitness of newly transferredmethods from analytical developments team as well as contractresearch organizations.

Close engagement with Analytical Development and QualityAssurance to build a sustainable GMP Quality Control platform tosupport growing portfolio of clinical development programs. Thisincludes ensuring harmonized approach to method development thatsupports the transition and implementation of methods fit forcommercial Quality control support.

Oversight, selection and management of contract QC laboratoriesfor multiple analytical assets. This includes technical duediligence, routine performance management and regular visits toensure sustained quality analytical deliverables.

Support internal and external GMP manufacture and supply of highquality gene therapy products for clinical trials, includingoversight of GMP sample handling, testing, QC stability program, QCrelease and stability data analyses and method data trending, outof specification investigations and Certificates of Analysiscreation.

Develop phase appropriate quality control capabilities, businessprocesses, and procedures to ensure robust product supply,including establishment of appropriate processes for specificationssetting and holistic control strategy.

Ensure that QC is aligned with all CMC stake holders, and incontinuous collaborative state with analytical development,pharmaceutical Development, manufacturing, QA, regulatory affairs,clinical development, and program management, as well as withexternal vendors (CROs and CMOs), and Qualified/responsiblePersons.

Team management and leadership, including team members anddevelopment plans. The Senior/Executive Director will establishcontinuous learning and improvement programs for the QC team,thereby ensuring all team members are engaged and passionate abouttheir work.

Promote a company-wide culture of safety, quality andresponsible mindset. This is includes having appropriate metricsand community ownership of these key cultural traits.

Qualifications: BA/BS, MS or PhD in a Biochemistry/MolecularBiology/Pharmaceutical Sciences or other relevant scientific fieldof study with 12-15 years of relevant experience working in QualityControl and/or Analytical Development with GMP experience in thePharmaceutical/ biotechnology industry.

In-depth technical and regulatory understanding of biologics orgene therapy QC and understanding of holistic control strategy forBiological/gene therapy therapeutic entities as well as applicableinternational regulations and standards in all phases of clinicaldevelopment. Good understanding and experience of GT manufacturingsciences and processes.

Proven leadership experience and people management skills withthe desire and ability to work in a fast-paced rare and ultra-rarecommercial Company with a sizeable clinical gene therapyprograms.

Strong collaboration, team-building, and organizational skillsare required

Established experience working with and management of thirdparty contractors and vendors.

Excellent written and verbal communication skills.

Early to Late Clinical stage and commercial CMC experience.

Travel up to 20-30% will be required (pending COVID travelrestrictions).

#LI-CZ# Ultragenyx Pharmaceutical is an equal opportunityemployer & prohibits unlawful discrimination based on race, color,religion, gender, sexual orientation, gender identity/expression,national origin/ancestry, age, disability, marital and veteranstatus. Reasonable accommodation will be provided for qualifiedindividuals with disabilities and for qualified disabled veteransin job application procedures, as required by applicable law. Ifyou have any difficulty using our online application system andneed an accommodation due to a disability, you maycontact Talent Acquisition by calling: (415)483-8800 or by emailing us at talentacquisition@ultragenyx.com . For electronic email and mailinquiries, please include a description of your requestedaccommodation, your name and contact information.

Note to External Recruiters : All candidate activity and openpositions are managed strictly through our Human ResourcesDepartment. Our Human Resources Department kindly requests thatrecruiters not contact employees/hiring managers directly in anattempt to solicit business and present candidates. Please notethat failure to comply with this request will be a factor indetermining a professional relationship with our organization.Submission of unsolicited resumes prior to an agreement set inplace between the Human Resources Department and the recruitingagency will not create any implied obligation. Inquiries ondeveloping a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com .

Keywords: Lever, Cambridge , Senior Director/Executive Director of Quality Control - Gene Therapy, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Director/Executive Director of Quality Control, Other , Cambridge, Massachusetts