Senior Director, Process & Platform Operations

Location
Cambridge
Posted
Jan 24, 2021
Ref
4976319002
Required Education
Associate Degree
Position Type
Full time
JOB PURPOSE

Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products.

The Senior Director of Process & Platform Operations is a key leadership position within Sana Technical Operations as we prepare to advance a pipeline of next-generation gene and cell therapy products to the clinic.

The role will lead and build a team of production associates, engineers and scientists to provide technical leadership to establish operations for production and supply of material from research through Phase 1 GMP for novel gene therapy (viral vector) products. The team, led by this role, will establish efficient production operations to supply early research material supply, critical materials (GLP tox), and enable GMP supply by leading tech transfer to GMP manufacturing. The role has technical accountability and oversight for supply of materials from internal or external (CMO) GMP facilities, partnering with process development, analytical, and GMP manufacturing teams. The role will engage in Sana's enterprise-level manufacturing and supply chain planning, including the build out of internal GMP capabilities and external supply chain networks. In this capacity, the Leader will contribute to line-of-sight for life cycle management, with focus on process/technology improvements to the platform and assessment of product comparability.

With a strong focus on both technical and operational excellence, this senior hands-on managerial position will play a leading role in shaping core production technology platforms at Sana and the advancement of therapeutic gene therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advanced therapies.

DUTIES AND RESPONSIBILITIES

The leader will oversee activities in support of early supply of quality research materials to guide pre-clinical candidate selection. With a mindset toward accelerating development, the leader will embrace both science and manufacturability to define and operationalize efficient production platforms for material supply across the early development horizon from candidate selection through to Phase 1 IND. The leader in this role will manage an operations team to supply early research, pilot scale supply and GLP study material supply, tech transfer and process establishment in GMP. The leader will participate with process and analytical development in early process characterization with an eye toward de-risking and troubleshooting production operations, use of scaledown models, and new manufacturing technology exploration.

The role will be a member of the Manufacturing network leadership team and will contribute to and influence gene therapy manufacturing and network strategies, and standards for both drug substance and drug product production. The role will work closely with Process & Analytical Development, Quality, External Manufacturing, Supply Chain and CMC/product lifecycle teams to advance our pipeline and establish a robust development network for new products. The role will be viewed as a technical thought leader internally and externally in manufacturing viral vectors and complex biologics.

The successful candidate will have industrial experience managing a process development team for biologics/vaccines (and/or preferably gene/cell therapy) and manufacturing operations, have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing and growing team.

Responsibilities:
  • Establish scientifically-sound and operationally-efficient production workflows for supply of quality research-grade viral vectors for early research studies. Oversee a research production capability to support production of novel viral vector compositions for research customers, perform early optimization & manufacturability assessments, manage a lean industrial workflow to supply small-volume and high-quality vectors in line with business/customer expectations of turnaround time and capacity.
  • Establish the requirements for the clinical manufacturing process for viral vector and ensure application of these requirements throughout the product life cycle. Leveraging a platform mindset to achieve speed and efficiency, establish processes at scale and define an approach for rapid introduction of new candidates. Be accountable for technical success of process operations in the supply of GLP and GMP material.
  • Identify opportunities to shape both the technology platform and manufacturing operations to build a platform within Sana to increase speed, gain efficiency, increase probability of success of supply, reduce cost, and ensure quality in meeting program deliverables across the Sana portfolio of programs. As with other advanced therapies, critical attention to raw materials is a key consideration.
  • Transfer processes developed to internal/external manufacturing sites. This includes ensuring clear definition of the clinical manufacturing control strategy and associated enabling documents/validation or supporting technical studies. Advise on developmental studies needed to ensure successful transfer and de-risking of clinical operations.
  • Engage with Process & Analytical Development to ensure sound process qualification, control and comparability strategies are in place to support the programs.
  • Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy for vector technologies.
  • Participate in the CMO selection process by evaluating CMO capabilities against technical requirements. Provide technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply. Participate in appropriate internal and joint CMO governance meetings (ex, joint steering committees). Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers
  • Hire and manage a team of scientists to define, operationalize, and maintain production workflows. Contribute to build-out of early product and process insights.
  • With a focus on technical excellence, the individual will oversee production activities and their: implementation, performance, troubleshooting, and trending.
  • With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost.
  • Participate in establishment of drug substance and drug product specifications and provide technical leadership in review of content for regulatory interactions.

QUALIFICATIONS

Basic Qualifications
  • Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of bioprocess principals and practice; a technical and people leader with experience managing department(s) with mid-level and senior employees.
  • Experience with the following cell culture, purification, chromatography, clarification technologies, tangential flow and normal filtration, aseptic processing and drug product, process automation, high-throughput process development, automated liquid handling, electronic notebooks.
  • Prior experience leading a team in Process Development, pilot scale production, tech transfer, and/or GMP manufacturing is important for success in the position.
  • Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma.
  • Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience.
  • Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects.
  • Demonstrates a respect for others and is open to new/different ideas.
  • Excellent written and verbal communication skills.

Preferred Qualifications
  • Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees.
  • Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in process development and operations for complex biological products.