Senior Manager / Associate Director External Manufacturing
Manager: Senior Director External Manufacturing
Department: Technical Operations
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.
Sangamo Therapeutics is seeking a Senior Manager/Associate Director of External Manufacturing who will be responsible for managing activities related to the GMP production of early and late phase clinical materials produced at contract manufacturing organizations (CMO) for the Company’s in-house and partnered programs. This role is primarily focused on CMO(s) for gene therapy and cell therapy manufacturing. As programs advance, the role will may also be responsible for managing commercial supply at CMO(s). This role will manage scopes of work at the CMO(s) per established contracts and act as primary contact with the CMOs. This individual contributor role will also be responsible for working with internal and CMO staff for the oversight and coordination of activities related to scheduling, manufacturing, quality, finances, supply chain and regulatory.
- Act as primary relationship manager and point of contact with the CMO(s) for gene therapy and and cell therapy manufacturing while working closely with Technical Development, Quality/Compliance, Quality Control, Supply Chain, Regulatory, Legal and Finance.
- Develop timelines, budgets and co-ordinate execution of activities for all elements related to the GMP production, testing and release of products manufactured at CMOs
- Lead and facilitate the meetings between Sangamo and the CMO(s) project team members.
- Coordinate the generation, review, execution and completion of scope of work (SOW) documents, corresponding purchase orders, invoicing and any necessary change orders. Ensure adherence to the contract and the SOW.
- Track project activities, deliverables and completion relative to budgets and Company objectives.
- 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.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelor's, Masters or PhD degree in life sciences, bioprocessing, chemical engineering or other related discipline.
- Minimum of 7 (senior manager) to 12 (AD) years related experience in the biotechnology or pharma industry with a primary focus on GMP manufacturing operations for biologics, ideally for Advanced-therapy Medicinal Products (ATMPs) including cell and gene-based therapies
- Experience in clinical development stage projects and/or additional experience in commercial manufacturing and supply
- Demonstrated skills in project management and working with vendors
- Proven track record of managing CMO GMP production operations and budgets
- Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
- Knowledge of cGMP Quality Systems including change control, discrepancy management, CAPA, lot release and validation
- Strong background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMP's a plus
- Advanced knowledge of drug development process and experience with gene therapy or cell therapies is highly desired
- Strong planning and tracking skills, able to see big picture, well-organized, focused on results, 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.
- Ability to travel up to 15%.
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.