Senior Director Process Development and GMP

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Job description

Who We Are:

ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode's lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.

Summary of Position:

The Senior Director Process Development and GMP position will lead, drive, and implement the strategic direction, technical hands-on execution, and operational excellence for successful process development and manufacturing activities throughout ReCode Therapeutics.

Responsibilities:

• This position will be responsible for leading and directing all aspects of process development and GMP manufacturing of RNA therapeutics. Lead, motivate, and develop technical staff.
• In a fast-paced environment, develop workflows to prioritize tasks such as risk assessment, process characterization, troubleshooting, process improvements and problem solving.
• Oversee manufacturing equipment design, built, installation, automation and commissioning.
• Serve as the technical process development and manufacturing leader to drive the development of projects and programs in various stages of the pipeline.
• Transfer processes to ReCode CDMOs. Oversee outsourced manufacturing, including technology transfer, product/process development, and GMP activities.
• Serve as the lead/stakeholder in various CMC teams to drive and align the process and manufacturing strategy with company-wide initiatives.
• Write and review CMC regulatory submissions (IND, IMPD, BLA / MAA) and work effectively with Regulatory to define CMC regulatory strategy and activities.
• Determine drug substance and drug product strategy to meet clinical and commercial needs. Work close with QA/QC ensure product quality and facilitate regulatory approvals. Achieve operational flexibility of supply chain.
• Serve as SME to the rest of the organization to incorporate process development and GMP concepts into product lifecycle.
• Present to senior management and at conferences; maintain visibility and influence inside and outside of the company.
• Create, maintain, and manage detailed project plans that continually calculate optimization timelines and parallel processes while appropriately managing risk.

Qualifications:

• PhD in chemical engineering, chemical or biological sciences with a minimum of 15 years industry experience in process and product development.
• Experience working with RNA therapeutics and LNP delivery technologies.
• Significant experience working with external CROs/CMOs.
• Extensive experience with process development and manufacturing.
• Understanding of cGMP compliance requirements associated with U.S., EU, ICH and other pertinent regulatory agencies.

Salary Range: $270,000 - $285,000

Please note that for remote positions, salary may be adjusted for cost of living

Benefits Offered for Full-Time Employees:

• No premium cost for employees - 100% subsidized by ReCode for full-time employees
• Company 401k contribution
• 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
• Mental health support for employees & their families
• FSA available, including a lifestyle spending account subsidized by company
• Employee discounts at hotspots

ReCode Therapeutics () offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.

ReCode Therapeutics is an Equal Opportunity Employer.

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