Sr. Engineer/Principal Engineer, Gene/Cell Therapy (Formulation & Fill/Finish)
Manager: Senior Director
Department: Technical Operations - Formulations & Fill/Finish
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. 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.
Sangamo Therapeutics is seeking a highly motivated individual with drug product process development and fill/finish experience to contribute to the development of best in class viral vector and cell therapy drug product manufacturing processes. The candidate will be responsible for strategizing and developing DP processes based on the product needs as well as internal/external manufacturing capabilities and infrastructure. Develop novel tools, small scale models, and process analytical capabilities to enhance process knowledge and robustness of technical package. Stay abreast of latest technological developments and insights in the cell and gene therapy manufacturing industry and internalize key technologies to meet business needs. You are expected to drive project milestones in fast paced matrix organization with strong negotiation and interpersonal skills to develop close working relationships with internal and external stakeholders. Create a positive work atmosphere with strong team spirit, effectively communicate, motivate, and inspire teams to excel in achieving short and long-term goals.
- Devise the DP process development, qualification and validation strategy for pipeline products
- Plan, design and execute process design and characterization studies based on product needs as well as internal/CMO site’s fill/finish process requirements
- Lead scale up and technology transfer of products across internal and external manufacturing sites.
- Provide on-going fill-finish manufacturing support to DP sites/CMOs including MAR support, process capability analysis, and impact assessments during quality investigations to ensure product and process health
- Contribute to the compilation and review of master/batch production records, change controls, standard operating procedures and guidance documents
- Author, review functional and cross-functional process characterization/validation protocols, multivariate studies, reports and drive timely execution with quality oversight
- Author regulatory section in support of investigation new drugs (IND) and marketing application submissions
- Manage, train and supervise contractors and consultants to drive program milestones and deliver organizational goals
- Participate and provide updates to CMC and functional teams of current and future state of project milestones
- Provide strategic guidance to the team in leveraging QbD tools & RRF strategy to take informed risk and accommodate accelerated timelines
- Drive innovation and strategic agility to build a futuristic vision and work packages for cell and gene therapy formulation and process development
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Ph.D. in chemical or biomedical engineering, pharmaceutical sciences, biochemistry, or related discipline and a minimum of 8+ years’ experience in industry or (BS/MS) with 10 + years of experience. Level will be determined by education, experience and skills
- 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
- 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
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.