Process Engineer/Senior Process Engineer, DP MSAT

Manager: Associate Director

Department: Technical Operations - Formulations & Fill/Finish

Location: Brisbane

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. Sangamo is a company where individuals can flourish, grow, and develop their expertise.
 

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

JOB SUMMARY:   

Sangamo Therapeutics is seeking a highly motivated individual with experience establishing and supporting drug product (DP) manufacturing facility and process. The fill/finish facility will be used to manufacture best-in-class viral vector and cell therapy DP. The candidate will be responsible for assessing, strategizing, developing, implementing, and supporting end-to-end DP infrastructure and processes based on the facility and product needs. This includes assessment of novel production facilities and tools such as modular DP filling, single use systems and components, ready-to-use primary packaging systems, small-scale models for process design, characterization, and validation, and process analytical capabilities to enable a robust facility and process for clinical DP production. We are looking for a candidate who is versed with the latest technological developments and insights in the cell and gene therapy manufacturing industry. The candidate is expected to drive project milestones in a fast-paced matrix organization with strong negotiation and interpersonal skills to develop close working relationships with internal and external stakeholders. The candidate should create a positive work atmosphere with strong team spirit, effectively communicate, motivate, and inspire teams to excel in achieving short and long-term goals.

ESSENTIAL FUNCTIONS: 

• Work closely with other engineers (site, mechanical, structural, electrical, chemical etc) to assess, install, qualify, and verify/validate a modular DP filling system with associated DS compounding and filtration containers and components
• Collaborate with the downstream process development group to ensure a smooth transition from purification and final formulation production steps to fill and finish activities
• Design and execute process development, characterization, and validation studies to support fill/finish infrastructure and process requirements to support the production of pipeline genomic medicinal products for clinical supply and resupply
• Lead scale up and technology transfer of products across internal and external manufacturing sites.
• Author, review functional and cross-functional process characterization/validation protocols, multivariate studies, reports and drive timely execution with quality oversight
• Provide on-going fill-finish manufacturing support including MAR support, process capability analysis, and impact assessments during quality investigations to ensure product and process health
• Lead teams to generate production SOPs and other related guidance documents and templates
• Contribute to the compilation and review of master batch/production records, change controls, standard operating procedures, and guidance documents
• Author regulatory section in support of investigation new drugs (IND) and marketing application submissions
• Manage, train, and supervise contractors and consultants if needed to drive program milestones and deliver organizational goals 
• Provide strategic guidance to the team in leveraging QbD tools & RRF strategy to take informed risk and accommodate accelerated timelines
• Motivated to work in a challenging environment requiring innovative solutions, quick decision making, prioritization of competing priorities, and ability to listen to others in a respectful way
• Drive innovation and strategic agility to build a futuristic vision and work packages for cell and gene therapy DP process development

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Ph.D. in chemical or biomedical engineering, pharmaceutical sciences, biochemistry, or related discipline and a 2+ years’ experience in industry. Will consider BS/MS with 6+ years of experience.  Level will be dependent on education, skills, and experience
• Experience in the assessment, installation, and qualification of DP production equipment and associated consumables and components following cGMP requirements
• Experience in designing and qualification of unit operations such as freeze/thaw, pooling/mixing, filtration, filling, capping, visual inspection, packaging etc.  
• Experience with biopharmaceutical product and process development, process-engineering, aseptic fill/finish operations and cGMP knowledge
• Experience in QbD methodologies and statistical analysis using JMP or Minitab
• Excellent analytical and communication (oral and written) skills are required
• Proven ability to work effectively in a cross-functional organization and to meet team objectives
• Self-starter, solution oriented with collaborative mindset and strong executive presence with strategic and analytical mindset

OTHER QUALIFICATIONS:

• Previous experience with gene and cell therapy products is a plus
• Experience with regulatory filings and HA communications is desirable

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 individual’s 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

Commitment to Safety

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 & booster, you will have an opportunity to request a reasonable accommodation consistent with applicable laws. 

Note to External Recruiters:  We do not accept unsolicited resumes from any source other than from the candidates themselves.