Associate Director/Director, CMC Strategy
Manager: Senior Director, CMC Strategy
Department: CMC Strategy, TechOps
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. 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.
The Associate Director, CMC Strategy is responsible for leading CMC projects by coordinating with stakeholders both internal and external to Tech Ops. Projects will primarily be in direct support ushering our portfolio of products from late stage clinical to commercial development. The Associate Director, working with Tech Ops functions, will develop an executable strategy and work processes for advancing late stage assets through process development, regulatory approvals, and product launch. In this role, the individual must work collaboratively with all stakeholders, to ensure effective communication, planning, coordination of deliverables and efficient implementation of the CMC development plan. The Associate Director will also ensure effective communication, reporting and escalation to Senior/Executive Management.
In this role, the Associate Director will work with a broad cross section of the company including SMEs from CMC, Supply Chain, Clinical, Regulatory and Research groups, as well as colleagues from Commercial Planning, Business Development, FP&A and Executive Leadership. Additionally, significant interaction is expected with external collaborators, partners and contract organizations.
The ideal candidate will have shown significant experience in these areas and will possess the ability to work with little direction or oversight.
- Lead the program CMC activities by working effectively and collaboratively with all internal CMC stakeholders (CMC Regulatory, internal and external Manufacturing, QA, QC, Supply Chain, Clinical Operations, Process Development, Analytical Development, Formulation Development, R&D) at the different stages of development. Establish a good working relationship with External vendors, working through the external manufacturing leads
- Foster a positive team culture of ownership and accountability including continuous evaluation, recognition, and process improvement
- Align the organization on the program priorities and apply appropriate level of detail and follow up
- Assist with proposed program changes ensuring they have the appropriate change rationale, taking into consideration the impact to the program development strategy, program timeline, program budget, resources, and overall program risk. Provide CMC input into comparability strategy as relevant
- Provide input on the regulatory strategy, review of product-related regulatory submissions, author CMC content as appropriate and support product-specific questions
- Support the product control strategy, including risk assessments, process characterization strategy, and process validation (PPQ) strategy
- Establish and maintain product knowledge expertise, ensuring critical processing knowledge is captured and shared appropriately
- Facilitate project discussions to ensure progress and identify appropriate team actions and risks
- Resolve project issues through collaboration with the team and escalation to the CMC leadership team, as appropriate
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- BS/MS/PhD degree in Biological Sciences, Bioengineering, or an associated discipline with 8+ years of direct CMC or C> related experience
- Experience in the biotechnology or biopharma industry with a primary focus on project/program management of CMC related activities
- Experience with late-stage development and product licensure is highly desired
- Leadership and management skills to grow and manage Program Development
- Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders
- Strong background in FDA, ISO, EMA, GMP and ICH requirements
- Proven experience with regulatory submissions (IND, BLA, MMA, etc.), ideally for products which were ultimately approved for commercial distribution
- 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.
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Strong focus on customer service
- Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables
- Stature, gravitas, and confidence to gain the credibility and respect of peers
- Self-reliant, a good problem solver and results-oriented
- Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives
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.