Senior Director, Process Development, In Vivo and Gene Editing Components

Company: Apex Systems
Location: Somerville
Posted on: June 16, 2022

Job Description:

Senior Director, Process Development, AAV 1263588Job Scope & Purpose:Our gene therapy client seeking an exceptional leader to build a highly collaborative, high performing team. This individual will work cross functionally with R&D, Manufacturing and Quality to develop and transfer processes to support clinical and commercial manufacturing for novel cell and gene therapy products. This job has the flexibility to be hybrid and they are based out of Cambridge, MA.Primary Job -Responsibilities:Direct internal and external efforts for Process Development needs with CDMOs to develop clinical and commercial manufacturing processes for gene therapy components including AAV and LNPParticipate in cross-functional CMC and program teams to drive cell and gene therapy products through clinical development efficiently and effectivelyProvide technical support for manufacturing materials for clinical supply and commercial manufacturingAuthor, review, and provide strategic guidance for regulatory filingsSupport Quality teams with required data, technical assessments and expertiseOversee and manage budget, resourcing planning, and strategic planning for departmentPrimary Job Requirements:Advanced education in life sciences with 10+ years of biotherapeutic process development experience used for manufacturing, and commercializing biologics and gene therapiesExpertise in tech transfer of protein and AAV manufacturing processesExtensive leadership experience overseeing process development teams and building strong CDMO partnershipsStrong understanding of industry standards and regulations (FDA, EMA, ICH, cGMP)Collaborate team oriented leader with exceptional communication and organizational skillsAbout Stratacuity:Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.PROVEN SCIENTIFIC PLACEMENT---Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.jditalia@stratacuity.comCode: TechOpsEEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.Job ID: 1263588Employment Type: FullTimeJob Area: Scientific and ClinicalFunction: Clinical ResearchIndustry: Computers General

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