Director, Analytical Development, Cell Therapy

Resilience is seeking an experienced Director of Analytical Development to provide technical leadership for collaborative client projects and internal technology development at our East Norriton, PA site. The successful candidate will be responsible for leading technical and operational analytical development teams to develop, characterize, and qualify functional and molecular cell therapy analytical tools as well as transfer and support analytical methods in QC operations across multiple cell therapy modalities. The Director will bring expert-level knowledge of cell therapy analytical tools and outstanding leadership capabilities to the role.

This leader will:

• Provide technical, tactical, and scientific leadership to the team in the development, qualification, and implementation of innovative, robust, cost-efficient analytical development capabilities that are clearly tied to business, client and scientific problems

• Guide a team of technical leaders on potency and molecular assay development and provide day-to-day support, career development and mentorship

• Provide technical and strategic guidance in the development of a toolbox of functional assays that can progress to implementation as potency assays, with phase-specific qualification

• Direct advancement of molecular analytical methods such as next generation sequencing and single cell PCR, and their applications to the characterization of cell therapy products

• Lead collaborations with operational teams to transfer in analytical capabilities and to address any problems or unexpected results in manufacturing and QC

• Interface with candidate clients to highlight company capabilities and approaches; author and provide critical technical feedback on client project proposals

• Provide representation to CMC teams for collaborative client projects for strong communication, strategy setting, and execution

• Collaborate with process development teams to ensure appropriate experimental design, sample analysis, and data interpretation

• Lead the gathering and analysis of data trends including assay controls and batch-specific data

• Direct authoring and review of technical and scientific documents, including (but not limited to): study protocols and reports, validation documents, SOPs, regulatory submissions, and test methods

• Serve as a technical beacon for the team by maintaining expertise, reviewing publications, attending conferences and networking across other Resilience sites to support an analytical development community of practice

• Foster a culture of innovation and an environment of technical mastery at all levels

• Collaborate with other site leaders to define work processes that maximize efficiency, predictability, and velocity

• Manage resource allocation and set priorities and objectives for the team to ensure timely completion of client and internal technology development deliverables

Required Qualifications

• PhD, MS or other degree in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering or related discipline with 10+ years relevant industry experience

• Proven leadership experience building and managing high performing teams

• Subject matter expertise and hands-on proficiency with potency assays, molecular assays, and flow cytometry assays for cell therapy product and process characterization

• Expertise in cell therapy analytical development

• Experience working in cross-functional CMC teams

• Understanding of regulatory requirements and trends related to cell therapy analytics

• Experience authoring regulatory submissions as well as an understanding of regulatory requirements and trends related to cell therapy analytical development

• Strategic and innovative thinker; track record of fresh insightful thinking by developing creative approaches to processes and practices

• Adaptable to rapidly changing environments and differing needs across projects

• Excellent written and verbal communication skills

Preferred Qualifications

• Experience in a customer-facing environment

• Experience with cell therapy-supporting drug substances, such as vectors or gene editing enzymes

• Expertise in product development of new analytical technologies

Other Ideal Personal Characteristics

• Open-minded and inquisitive regarding the future of medicine and biomanufacturing

• Excellent leadership that builds bridges and retains talent

• Responds to challenges with creativity

• Embodies the Resilience phenotypes of grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership

• Intellectually curious, flexible, able to contribute at a very high level, as well as possessing a hands-on manner, when necessary

• Collaborative style, with an ability to build consensus among both internal stakeholders and clients

• A person who earns trust through integrity and technical ability

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Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $189,000.00 - $239,250.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.