Senior Director, Process Development, In Vivo and Gene Editing Components
Company: Apex Systems
Location: Somerville
Posted on: June 16, 2022
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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
Keywords: Apex Systems, Somerville , Senior Director, Process Development, In Vivo and Gene Editing Components, Advertising , Somerville, Massachusetts
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