Director, External Manufacturing

The Role:

Life Edit is looking for a Director, External Manufacturing who will provide operational oversight for manufacturing of gene editing drug substance and drug product at Contract & Development Manufacturing Organization (CDMOs) for clinical and commercial application of Life Edit/ElevateBio and their partners’ portfolio of therapeutics, which encompass ex vivo editing of cell therapy products and in vivo delivery of gene editing tools. This role will focus on the management of external vendors for recombinant proteins, synthetic guide RNA, ribonucleoproteins, mRNA and RNA delivery vehicles such as lipid nanoparticles (LNP), or other mechanisms for delivery of gene editing tools and delivery devices. The candidate will closely interact with ElevateBio’s quality control, quality assurance, supply chain, regulatory affairs and clinical operations to support Life Edit/ElevateBio and their partners’ therapeutic needs. This position will drive the outsourcing to vendors for process and analytical development, tox material as well as GMP manufacture and analytical testing of drug substance and drug product. The candidate will also work closely with the Life Edit research scientists, to aid in the seamless transition of novel editing compositions into development and GMP manufacture, while providing guidance on improvements in the discovery phase that ensure GMP manufacturing success.

Here’s What You’ll Do:

• Provide technical support and leadership for the transition of protein, synthetic guide RNA, mRNA or other mechanisms for delivery of gene editing tools from discovery to a CDMO for development and GMP manufacturing
• Establish relationships with suppliers, obtain quotes, perform technical visits and lead decision-making to identify primary and backup options based on capabilities/cost/timings
• Negotiate Master Service Agreements (MSAs), Statements of Work (SOWs) etc. with suppliers and likewise as well as supply agreements with partners
• Support supplier qualification audits as a technical expert
• Collaborate effectively and leverage Life Edit and ElevateBio Research and Development teams, Program management, Elevate Bio Basecamp quality, supply chain, regulatory affairs teams to achieve goals
• Act as the subject matter expert for external manufacturing of gene editing tools and delivery devices
• Review and approve GMP batch documentation, standard operating procedures and technical reports
• Provide support by authoring CMC sections of regulatory filings and serving as an SME for health authority audits, questions and meetings as needed
• Manage key activities and timelines ensuring successful external technology transfer
• Work closely with the Quality team to ensure compliance during external GMP manufacturing and support GMP batch release
• Own change controls and deviations related to GMP production at CDMOs / device suppliers and lead investigations and escalation through LEAN Tier meetings and CMC Governance as necessary
• Coordinate with Supply Chain and CDMOs to obtain appropriate import/export permits
• Provide updates to the supplier Annual Quality Review and Supplier Review Board as needed
• Author and/or review/approve procedures and training materials as appropriate for above

Requirements:

• B.S., M.S. or Ph.D. in a scientific or engineering discipline
• 10+ years of experience (B.S. or M.S.) or 8+ years of experience (Ph.D) in biotech or pharmaceuticals working on human biologics in relevant roles associated with development, manufacturing, process engineering, quality or supply chain
• Experience moving gene therapies, recombinant proteins/ribonucleoproteins, RNA medicines, or other nucleic acid and/or LNP therapeutics through development into the clinic and commercialization
• Experience with gene editing, RNA-guided nuclease protein/guide RNA production and cell+gene therapies is advantageous
• Extensive working knowledge of cGMP Quality Management Systems and FDA/EU guidance and regulations
• Extensive experience in leading product/process oversight within a GMP setting, such as leading changes and investigations, technology transfer, process monitoring, validation lifecycle and regulatory submissions / Q&A with regulators
• Project management skills, including strategic and tactical projects/tasks, tracking and adhering to budgets, reporting project and campaign metrics, and other project management tools
• Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team)
• Strong technical writing and editing skills
• Travel within and outside the US may be required (maximum 25% of time)

We’re committed to finding the best ways to support our teams so they can do their best work. We take care of our employees, right from the start.

Health & Wellness

• Medical, vision, and dental insurance covered at 90%
• Low deductible, no co-insurance and no copays for mental health visits (for in-network care)
• Annual fitness reimbursement
• Employer paid for access to wellness apps and programs like Task Human

Financial

• Competitive compensation
• 401(k) retirement plans with a 4% employer match and no vesting period
• Employer-paid life insurance and short- and long-term disability insurance
• Employer-sponsored flexible spending accounts (FSA) and dependent care account (DCA)
• Access to a 1-on-1 financial advisor
• Commuter reimbursement benefit
• Monthly cell phone stipend

Time Off & Flexibility

• Unlimited paid time off, including vacation, sick leave, family leave, personal days, and bereavement
• 18 paid company holidays, plus an end-of-year holiday shut down
• 12 weeks of parental leave
• Federal Family and Medical Leave Act (FMLA) and Massachusetts Paid Family and Medical Leave (PFML), administered by Unum

Development Journey

• Insights Discovery training for every employee to make the most of workplace relationships
• Ongoing professional development, including manager training
• Access to LinkedIn Learning, a self-guided online education platform

Why join Life Edit Therapeutics?

Life Edit Therapeutics, an ElevateBio portfolio company, is a gene editing company on a mission to rewrite the future by curing disease, making any edit, anywhere. Life Edit has built a world-class genome editing platform with one of the world’s largest and most diverse collections of novel RNA-guided nucleases (RGNs) and base editors. The company’s next-generation editing systems will propel the development of novel human therapeutics by enabling ex vivo engineering for cell therapies and regenerative medicines and in vivo delivery of gene therapies.

Our Vision:  To pave the way to faster, safer, gene editing therapeutics that cure disease and improve patient lives

Life Edit is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Life Edit will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.