Associate Director, Gene/Cell Therapy (Formulation & Fill/Finish)
Manager: Senior Director
Department: Formulations & Fill/Finish
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. 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 formulation and fill/finish experience to contribute to the development of best in class viral vector and cell therapy drug product manufacturing processes. You will be responsible for building and leading diverse team, develop talent and manage employee development. Provide strategic guidance for drug product formulation, process development and fill/finish manufacturing operations. Drive project milestone in fast paced matrix organization with strong negotiation and interpersonal skills to develop close working relationships with internal and external stakeholders. You will be expected to contribute new ideas and innovative solutions to technical challenges. Draft and review regulatory submissions for global filings. Lead process technology transfer to internal manufacturing facility as well as CMOs. Create a positive work atmosphere with strong team spirit, effectively communicate, motivate and inspire teams to excel in achieving short- and long-term goals.
- Build, mentor, supervise a talented team of full-time employees, contractors and consultants to deliver organizational goals
- Support interest-based employee development to foster engagement and positive work culture.
- Lead pharmaceutical development activities to support Tox, phase I/III formulation and DP process development, BLA licensure and commercial launch
- Author, review functional and cross-functional process characterization/validation protocols, multivariate studies, reports and drive timely execution with quality oversight
- Strategic guidance to the team in leveraging QbD tools & RRF strategy to take informed risk and accommodate accelerated timelines
- Devise the process technology transfer, qualification and validation strategy for clinical/commercial product launch and/or transfer
- Drive innovation and strategic agility to build a futuristic vision and work packages for cell and gene therapy formulation and process development
- Provide on-going fill-finish manufacturing support to DP sites/CMOs including Technology transfers, MAR support, impact assessments during quality investigations to ensure product and process health
- Contribute to the compilation and review of master production records, standard operating procedures, development/validation protocols and reports
- Excellent analytical and communication skills, and proven ability to work effectively in a cross-functional organization to meet team objectives
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Ph.D. in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and a minimum of 8+ years’ experience in industry or (BS/MS) with 10 + years of experience
- Experience working with formulation design or reformulation of existing products
- Proficiency with applying chromatographic (HPLC, UPLC, column chromatography) methods, capillary electrophoresis and biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, particle analysis, etc.) for formulation characterization
- Experience in QbD methodologies and statistical analysis using JMP or Minitab
- Excellent oral and written communication skills are required
- 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
- Experience with fill finish and product presentation 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.