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Associate Director, Downstream Process Development - Nucleic Acids

Employer
Resilience
Location
Allston, MA
Start date
Nov 8, 2022

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Job Details

Relocation Assistance Offered

Resilience (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit www.resilience.com.

Role:

  • Lead a downstream process team on both early and late stage purification process development for diverse nucleic acid modalities to deliver high purity product and yields for non viral gene therapy applications

  • Oversee and implement chromatography and tangential flow filtration (TFF) development for nucleic acids (DNA and RNA) that aligns to client and platform needs

  • Drive the design and development of innovative downstream process solutions for multi-phase drug substance and product development, collaborating with a diverse team of process engineers, formulation/drug delivery and analytical scientists

  • Develop and adapt protocols and procedures based on experimental data and literature reviews, working with both clients and on internal platform processes

  • Participate in group meetings with multidisciplinary teams and contribute creatively to developing the company’s core IP

  • Support process development, optimization and characterization at bench and pilot scale, while adding in detailed concept design and process transfer for cGMP manufacturing

  • Work with nucleic acid leadership team to develop business and technical strategies for the organization

Job Responsibilities:

  • Innovate, develop, and execute chromatographic and TFF process techniques for the purification of mRNA, synthetic DNA, lipid nanoparticles, and other related nucleic acid therapeutic modalities.

  • Utilize internal and external networks to maintain and enhance current knowledge of emerging technologies in chromatography to support improvements for existing purification strategies.

  • Collaborate with analytical team and support process characterization.

  • Communicate technical information to within the RESILIENCE organization and with external groups.

  • Establish goals aligned for the downstream process team aligned with RESILIENCE corporate strategy.

  • Evaluate new technology/equipment across multiple programs.

  • Design experiments within QbD framework

  • Write and review technical documents, including study proposals, development report, SOPs, and MBRs, along with support client regulatory submissions.

  • Ensure team maintains laboratory equipment and up-to-date ELNs

Qualifications:

  • BS with 15+ years, MS 10+ years or PhD + 5 years of industry experience with a degree in Chemical Engineering/Biological Engineering/Biochemistry/Chemistry.

  • Strong scientific background with extensive hands-on experience in nucleic acids purification techniques is preferred

  • Ability to train and mentor junior team members

  • Understanding of methods for nucleic acid production, structure and function is crucial

  • Strong computer, scientific, and organizational skills.

  • Excellent communication (oral and written) and attention to detail.

  • Self-motivation, adaptability, and a positive attitude.

  • Desire to learn new techniques, keep accurate records, and comply with all company policies.

Preferred Experience:

  • Proven track record in downstream process development and process transfer in biotech industry. Previous team leadership experience desirable.

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Find Us
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States
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