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Associate Director/Director, AAV Cell Culture Process Development

Employer
Sangamo Therapeutics, Inc.
Location
Brisbane, CA
Start date
Nov 12, 2021

View more

Discipline
Engineering, Manufacturing & Production, Process
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Title: Associate Director, Cell Culture Process Development

Manager: Sr. Director, Process Development
Department: Technical Operations
Location: Brisbane, CA

Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today’s medicines can only treat symptoms. At Sangamo, we are passionate about transforming lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.

We are seeking top talent to join our mission. Let’s build a better future together.
 

JOB SUMMARY:   

The Associate Director, Cell Culture Process Development (CCPD) is accountable for and leads all aspects of cell culture process development for Sangamo’s gene therapy platform focused on AAV. This role is responsible for leading cell culture development activities starting from Research, progressing through tox and clinical studies, and ultimately defining the process needed for initial IND, Phase 3, and commercial launch. Process development is also responsible for the manufacture of research grade gene therapy materials for characterization and animal testing. Given that many of these activities are on the critical path, this person will work closely with the project teams to ensure timely delivery of material and information.

ESSENTIAL FUNCTIONS: 

  • Oversee cell culture process development of our AAV platform. Lead the CCPD team through establishment of goals, plans and performance metrics that are periodically reviewed & reported to the organization
  • Provide leadership and direction to the CCPD group, manage and coach junior staff
  • Plan and allocate resources to meet organizational objectives
  • Develop and manage CCPD group’s cost & capital budgets
  • Support tech transfer to manufacturing through disciplined output to Technical Operations teams
  • Lead a team which has oversight for the cell culture portion of the following activities:
    • Process development through IND, late stage clinical and final process validation.
    • Manufacture of non-GMP materials for animal and research studies
    • Clear communication with the project teams to ensure timely dissemination of information (titers, yields, purity, CPPs, CQAs, etc.) and delivery of materials.
    • Generation of technical reports as needed
    • Authorship of CMC sections for regulatory submissions
    • Provide technical support to manufacturing and CMO
  • Track project activities, deliverables and completion relative to budgets and Company objectives
  • Supports strategic planning by identifying development scenarios, risks and options, collaborating with Research, Program management, Clinical and internal and external Manufacturing teams
  • Identify risks and assumptions in plans, anticipates problems and plans for contingencies. Removes obstacles to move work forward and/or to get efforts back on track
  • Evaluates new cell culture technologies that provide advantages in the manufacturing and attainment of quality in products

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

  • Minimum of a bachelor’s degree in life science or engineering field; a PhD is preferred
  • Minimum of 8 years relevant experience in the biotechnology or pharma industry. Direct experience with gene-based and rAAV-based therapies will be a plus
  • Proven experience in developing cell culture processes leading to successful regulatory filings
  • Experience with late-stage development and process characterization/validation in support of product licensure is highly desired
  • Experience managing and coaching junior staff is also highly desired
  • Familiar with FDA, ISO, EMA, GMP and ICH requirements

OTHER QUALIFICATIONS:

  • Strong planning and tracking skills, capable of managing multiple projects, excellent time management with respect to priorities and self-management
  • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
  • Excellent written and oral communication skills

Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.

COVID-19

Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role.  If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws. 

Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part.

If you wish to be considered for the presentation of candidates, please contact us through Recruiting@sangamo.com. Attach your contact information, your area of specialty, and any marketing information you wish to provide. Someone from the Talent Acquisition Department will contact you directly if there is a business need for your services.

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Company

Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.

We are seeking top talent to join our mission. Let’s build a better future together.

Stock Symbol: SGMO

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Company info
Website
Phone
(510) 970-6000
Location
7000 Marina Blvd
Brisbane
CA
94005
United States

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