drjobs Associate Director, Purification Development

Associate Director, Purification Development

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Job Location drjobs

Brisbane - Australia

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Title: Associate Director Purification Development
Manager: Director Process Development
Department: Technical Development
Location: Brisbane CA
Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases using our wholly owned highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo we are dedicated to building a robust sustainable genomic medicine pipeline that addresses life-limiting conditions by replacing todays symptom-focused treatments with tomorrows genomic cures. 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. Lets build a better future together.
JOB SUMMARY:
Sangamo Therapeutics is seeking an Associate Director Purification Development to lead efforts in developing new viral and non-viral processes for gene therapy products. This includes development of novel purification methods for adeno-associated virus (AAV) production in Sf9 and HEK293 cell lines production of viral vectors for use in preclinical studies and supply the development and research material needs. The Associate Director is responsible for providing senior technical and scientific leadership to the downstream PD team including upper-level scientists to achieve project milestones. They are also responsible for leading downstream development activities starting from Research progressing through toxicological and clinical studies and ultimately defining the process needed for initial IND Phase 3 and commercial launch. 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. The Associate Director works with the downstream purification team to produce materials to advance new technologies into clinical programs. This role requires working collaboratively with upstream process development analytical and formulation development partners to develop new downstream purification technologies for improved vector production processes. This position will oversee and manage the downstream purification staff ensure seamless delivery of materials for programs and develop presentation plans to represent Sangamo at conferences and meetings. The ideal candidate embraces adaptability excellent planning and communication skills as well as the ability to work in a fast-paced team-oriented multidisciplinary environment.
ESSENTIAL FUNCTIONS:
  • Lead and drive the development of robust purification processes for viral vector manufacturing to improve efficiency scalability and product quality with a focus on innovation and optimization.
  • Build mentor and supervise a talented team of employees and contingent workers to deliver organizational goals
  • Serve as technical operations SME on downstream purification of viral vectors
  • Provide strategic direction and technical guidance to the downstream process development team including mentorship and professional growth of team members.
  • Support tech transfer to manufacturing (internal/external) through disciplined output to Technical Operations teams for Sangamos AAV platform
  • Oversee PD scale and at-scale vector production activities within technical development
  • Partner with internal stakeholders and external CDMOs to lead downstream process development and characterization activities at CDMOs.
  • Supports strategic planning by identifying development scenarios risks and options collaborating with Research Program management Clinical and internal and external Manufacturing teams.
  • Process development through IND late stage clinical and final process validation; authorship of CMC sections for regulatory submissions.
  • Author and review relevant sections of regulatory submissions and documentation.
  • Collaborate with cross-functional teams (clinical quality regulatory) to plan development activities and produce necessary reports for regulatory filings.
  • Facilitate effective communication and alignment across departments while keeping team members and leadership informed of progress.
  • Stay updated on evolving industry regulations new process technologies and innovative development strategies.
  • Oversee laboratory operations ensuring compliance with safety standards permits infrastructure maintenance and planning for improved utilization.

EDUCATION EXPERIENCE AND SKILLS REQUIREMENTS:
  • PhD in Chemical Engineering Biochemical Engineering or Biological Sciences or related fields with 8 years of experience in industry. BS/MS with additional experience will be considered. Industry experience must include process development of viral vectors and/or other biologics modalities.
  • At least 5 years of direct experience with gene-based and rAAV-based therapies is preferred. Expertise in virology with some experience in AAV production preferred but not required.
  • Proven experience in developing purification processes leading to successful regulatory filings. Demonstrated familiarity with FDA ISO EMA GMP and ICH requirements. Experience with late-stage development and process characterization/validation in support of product licensure is highly desired.
  • Experience managing coaching and developing others.
  • Experience in setting up and leading PD laboratory operations.
  • Advanced problem-solving and analytical skills for interpreting complex scientific data and devising actionable solutions.

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 communication (written oral interpersonal and presentation) and organizational skills with a proven ability to deliver key information effectively to stakeholders and leadership.
  • Demonstrated ability to collaborate effectively in a multi-disciplinary team.
  • Strong leadership abilities including team management and the capacity to influence and collaborate across diverse teams.
  • Strategic and tactical mindset capable of adapting in a fast-paced dynamic environment with shifting priorities.

We encourage you to apply even if you dont meet all the qualifications. We believe in the value of diverse perspectives and backgrounds and we welcome candidates who are eager to learn and contribute to our mission.


Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity equity and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individuals race color sex gender identity gender expression religion age national origin or ancestry citizenship physical or mental disability medical condition family care status marital status domestic partner status sexual orientation genetic information military or veteran status or any other basis protected by federal state or local laws.

Pay Range
The anticipated salary range is for candidates who will work in our San Francisco Bay Area work locations. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience with the job type and length of experience within the industry education etc. This salary range may not apply to remote positions that work in other states.

Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves. If you wish to be considered for the presentation of candidates please email We will reach out to you directly if there is a business need for your services.
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Required Experience:

Director

Employment Type

Full Time

Company Industry

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