Our Current Job Opportunities
Questions? Contact jobs@deverratx.com
Process Development / Quality / Manufacturing
Clinical Operations
Research
Head of Manufacturing
The Head of Manufacturing, reporting to the Chief Scientific Officer, will lead the strategy and teams related to manufacturing of clinical and commercial supplies for Deverra. This leader is a hands-on technical expert and people leader responsible for the manufacture of research grade, cGMP clinical and commercial products and all operational aspects including productivity, cost, planning and ongoing business processes in manufacturing. The Director will also lead critical relationships with contract manufacturing organizations, ensuring strong partnerships and ability to meet evolving business needs.
This leader has a direct influence upon business and functional strategies, ensuring that Deverra stays on schedule, meeting the key targets and profitability measures that meet or exceed the goals set by executive management.
Responsibilities:
• Build, train, sustain and motivate a multi technology operations team capable of achieving productivity targets and output requirements.
• Develop and sustain employee engagement by creating an environment of continuous improvement, optimizing schedule adherence, refining operational efficiency, and increasing profitability and productivity.
• Lead Operational Excellence initiatives to improve operational efficiencies within areas of responsibility.
• Effectively work with all departments at Deverra to ensure corporate goals and initiatives are met.
• Direct cross-functional teams comprised of subject matter experts in the areas of Manufacturing and Materials Management.
• Develop and employ quality and business metrics for assessing productivity/profitability.
• Develop, execute and achieve annual budget for Manufacturing and Materials Management to utilize resources effectively and efficiently to meet business goals.
• Develop capital expenditure justifications and recommendations.
• Ensures compliance with all applicable corporate and regulatory SOP, cGMP, and safety guidelines, working with site Quality relevant to this position.
• Effectively manages employee relations including hiring, discipline, rewards and recognition, and effective human capital resources allocation within the Manufacturing Department.
• Actively influence and participate with Site Leadership Team by representing all manufacturing operations and establish effective cross-functional leadership relationships and presence.
• Participates and represents company in regulatory audits and inquiries relevant to this position.
• Provide direction to ensure and coordinate sustained supply of all source/raw materials and establish anticipated growth rates.
• Ensure there are regular manufacturing operations meetings to drive safety, cGMP compliance and adherence to plan.
• Direct the manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions.
• Support the identification and introduction of new technologies.
• Keep abreast of technical and regulatory developments in the cell therapy field that are directly/potentially applicable to site manufacturing operations and growth areas.
• Maintain the operational manufacturing facility in the highest level of cGMP compliance in accordance with FDA.
• Maintain effectiveness of the Quality System components relevant to this position.
• Other duties as assigned.
Requirements:
• Bachelor's degree required in life science or engineering; graduate degree preferred.
• Experience producing phase III and/or commercial products is required.
• Minimum of 10 years of experience in Manufacturing operations in a cell therapy, biotechnology or pharmaceutical manufacturing organization. Cell therapy manufacturing experience highly preferred.
• Experience working for or with a contract manufacturing organization.
• Demonstrated experience leading commercial cGMP pharmaceutical manufacturing operations.
• Experience leading cross functional teams with direct experience leading an independent manufacturing site preferred.
• Experience in root cause investigations and successful implementation of corrective actions and counter measures.
• Experience bringing new products from development to full commercialization.
Skills and Knowledge:
• Comprehensive understanding of cGMPs (minimally FDA and EMA), quality systems and compliance requirements for clinical and commercial pharmaceutical manufacturing
• Excellent written and oral communication skills and effective interpersonal skills
• Critical thinking and strong problem solving and process improvement skills
• Effective leadership and decision-making skills
• Excellent organizational and analytical skills
• Demonstrated interpersonal skills to develop effective working relationships with internal stakeholders, and cross-functional, cross-site project teams.
Abilities:
• Ability to multi-task and balance priorities
• Ability to travel up to 50% of the time
Clinical Trial Manager
The Clinical Trial Manager (CTM) is a key member of the Clinical Operations Team, supporting the successful execution of clinical trials, and Investigator Initiated Studies in oncology and cell immunotherapy. The CTM has primary responsibility for implementing studies across clinical trial sites and quality oversight of site management and monitoring activities. This position reports to the Director of Clinical Operations and will work closely with the Medical Monitor and other cross-functional representatives within both Deverra Therapeutics and designated CROs and third-party vendors.
Responsibilities:
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Project lead that facilitates information flow between clinical trial sites, Deverra team members, CROs, and vendors.
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Tracks and reports on progress of study including start-up, site activation, patient enrollment, monitoring and close-out activities, making sure that it is in alignment with project goals and corporate timelines.
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Assists in identification and hiring of CROs and third-party study vendors (RFPs, Bid defense meetings, …).
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Oversees performance of CROs, third party vendors, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to the responsible party.
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Develops, writes and/or contributes to preparation of clinical protocols, amendments, informed consent forms, study guides, manuals, plans, case report forms, and any other clinical research related documents.
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Performs clinical data review of data listings and summary tables, including query generation
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Reviews key study quality metrics and determine appropriate action in conjunction with study team. Performs clinical data review of data listings and summary tables, including query generation. Performs data cleaning activities.
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Identifies, evaluates, and selects, and oversees clinical trial sites.
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Develops and maintain good working relationships with investigators and study staff.
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Manages investigational product (IP). Responsible for review or approval of IP release packages.
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Oversees research specimen collection, reconciliation, and shipment as needed, in conjunction with third party vendors.
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Manages contracts, change orders and budgets with investigative sites and CROs.
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Ensures conduct of clinical trials according to the study protocol, SOPs and ICH/GCP regulations and study-specific manuals and procedures; collaborates with clinical operations director to ensure inspection readiness.
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Participate in the preparation and follow-up of internal process audits, vendor and study site quality audits, as well as regulatory authority inspections.
Education, Experience and Skills:
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BS/BA (or equivalent) in one of the life sciences with a minimum of 5 years direct experience in clinical trials or equivalent level of education and experience.
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Demonstrated successful management of CROs and multidisciplinary teams.
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Clinical trial management in pharmaceutical, biotech and clinical trial management experience, preferred.
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Experience in Phase I-III clinical trials, including multi-national studies and Investigator Initiated Studies.
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Oncology and Cell therapy experience preferred.
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Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team, and demonstrated success in problem solving.
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Excellent communication and organizational skills.
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Thorough knowledge of FDA and GCP/ICH requirements.
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Exceptional attention to detail.
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Proficiency with MS Office products Word, Excel, PowerPoint, SharePoint.
Director, Head of Cell Engineering
We are looking for a Head of Cell Engineering to lead and manage the development of our gene modified cell therapy products, including stem/progenitor cells, NK cells, and myeloid cells. This position will oversee the evaluation, incorporation, and optimization of emerging cell engineering technologies into our stem cell expansion platform for our modified immune cell products. The candidate will also support the development of analytical methods to contribute to the CMC strategy for IND applications and scale-up of lead candidates. The successful candidate will be responsible for defining and hiring key roles within the organization and leading a team of scientists to execute on strategies to genetically modify and characterize Deverra’s modified cell therapy products, including work with potential academic and industry partners. The ideal candidate has a track record of leading teams and individuals on the execution of technical strategies to modify immune cells, expertise in analytical development and relationship-building with external manufacturing partners and contract testing laboratories. This position will work directly with the discovery research, process development, and manufacturing teams to advance Deverra’s modified immune cell products. The final level of this position will be based on the candidate’s qualifications. This is a full-time position reporting to the Senior Director of Discovery Research, and is located in Seattle, WA.
Responsibilities:
• Lead the cell engineering team to successfully execute the development of gene modified cell therapy products using cutting-edge gene editing technologies (viral vectors, mRNA, knock-in/knockout approaches, etc.)
• Help establish timelines and budgets for cell engineering group
• Oversee the establishment of in-house production of gene modification materials (e.g. viral vectors, mRNA) and/or external sourcing of these materials
• Direct the development of analytical methods for characterizing gene modification materials and engineered cell products (mRNA, protein, genome integrity)
• Supervise and mentor scientists within the cell engineering group
• Author, review and approve technical documents including reports and SOPs, and support IND regulatory submissions
• Support the creation and maintenance of the cell engineering and analytical labs including acquiring equipment, supplies, and hiring
• Identify and work with external manufacturing partners and contract testing laboratories for the scale-up and analysis of lead candidates
• Participate in program teams to design and execute CMC activities for the development of gene modification materials and engineered cell products
• Provide critical lab support and guidance while working with other scientists in a collaborative team environment
• Mentor and inspire team members as a tireless champion of bringing lifesaving cellular therapies to people in need
Qualifications and Skills:
• Ph.D. with 10+ years or M.S. with 15+ years of relevant experience in biological/chemical engineering, virology, or pharmaceutical sciences, preferably in the biotechnology industry
• Proven track record of leading teams and individuals to genetically modify immune cell products
• Strong expertise in gene editing primary human immune cells using viral and non-viral gene delivery methods
• Extensive experience in generating and analyzing viral vectors (lentivirus, retrovirus, and/or AAV)
• Deep understanding and expertise in CRISPR knock-in/knock-out editing techniques or similar technologies
• Expertise in methods to characterize genetically modified cells including flow cytometry, microscopy, molecular/biochemical assays (NGS, RNA/DNA, qPCR, ELISA, western), in vivo models
• Experience in working with CMOs to scale-up viral vectors, plasmid DNA, and/or mRNA
• Comfortable in a fast-paced small company environment with broad responsibilities, meet deadlines, and prioritize work on multiple projects
• Strong desire to be part of growing company and to make an impact on pipeline product development and priorities
• Excellent interpersonal, oral, and written communication skills.
Senior Scientist, Macrophage Biology
We are looking for a highly motivated and experienced PhD Scientist with in-depth knowledge and expertise in myeloid cell biology, immunotherapy, and tumor immunology to lead the development of allogeneic macrophage cell therapies, including engineered cell therapies. This position will oversee the generation, optimization, and characterization of macrophages using our cell expansion platform. The successful candidate will build and lead a team of scientists to expand Deverra’s immune cell therapy product pipeline for myeloid cells. This position will communicate and collaborate within and across disciplines, both internally and with outside partners. This is a full-time position reporting to the Senior Director of Discovery Research, and is located in Seattle, WA.
Primary Responsibilities:
• Serve as scientific lead for macrophage biology program. Stay up to date on literature and current macrophage therapies in development
• Lead the efforts in establishing timelines and budgets for this program
• Implement expertise in isolating, culturing, and characterizing primary immune cells for the development of myeloid cell products
• Carry out modification of myeloid cells using genetic engineering technologies
• Build and manage a group of scientists to establish the macrophage biology team
• Develop and refine analytical methods (multiparameter flow cytometry, microscopy, ELISA, western, qPCR) for evaluating myeloid cells
• Oversee establishment of mouse models and testing lead candidates
• Design, execute, interpret experiments, and present data to various groups within the organization and with external collaborators
• Assure that scientific rigor and data integrity is applied to all studies (including controls and demonstrating reproducibility)
• Provide critical lab support and guidance while working with other scientists in a collaborative team environment
• Prepare technical reports, protocols, summaries, and presentations supporting experimental results in a timely manner
• Collect, maintain, and organize primary data for timely analysis in accordance with company policy
• Mentor and inspire team members as a tireless champion of bringing lifesaving cellular therapies to people in need
Qualifications and Skills:
• Ph.D. in immunology or related scientific discipline with 7+ years of relevant academic or industry experience
• In-depth knowledge of myeloid cell biology and tumor immunology
• Experience in genetic editing/cell engineering a plus
• Strong hands-on expertise in immunologic assays (immune cell activation, suppression, proliferation, phenotyping, and cytokine analysis), culturing primary immune cells including monocytes, macrophages, dendritic cells, and mouse models to evaluate macrophage biology
• Expertise in the development of biochemical, molecular, and cell-based assays for testing drug candidates (ELISA, western, qPCR, phenotyping, flow cytometry, microscopy)
• Strong troubleshooting, contingency planning, and decision-making skills
• Designing and managing multiple projects in academic or industrial setting
• Experience in training and managing junior scientists
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities; able to work independently and within a team; have a “do-what-it-takes” attitude
• Excellent interpersonal, verbal, and written communication skills and record-keeping ability
Scientist II, Cell Engineering
We are looking for a highly motivated and experienced Scientist II to drive the development of our gene modified cell therapy products. This position will evaluate and incorporate emerging cell engineering technologies into our stem cell expansion and differentiation platform. The successful candidate will be responsible for the hands-on development and execution of viral and non-viral strategies to genetically modify Deverra’s cell therapy products. This position will communicate and collaborate within and across disciplines, both internally and with outside partners. The candidate will contribute to the generation of new off-the-shelf cellular therapies that fuel the research pipeline. This is a full-time position reporting to the Head of Cell Engineering and is located in Seattle, WA.
Primary Responsibilities:
• Implement expertise in viral vectors and cutting-edge gene editing technologies for the development of engineered immune cell products (viral vectors, mRNA, knock-in/knockout approaches, etc.)
• Hands-on generation of gene modification materials (e.g. viral vectors, mRNA) and/or oversee external sourcing of these materials
• Develop and refine analytical methods for evaluating gene modification materials and engineered cells
• Design, execute, interpret experiments, and present data to various groups within the organization and with external collaborators
• Provide critical lab support and guidance while working with other scientists in a collaborative team environment
• May supervise associate staff
• Assure that scientific rigor and data integrity is applied to all studies (including controls and demonstrating reproducibility)
• Prepare technical reports, protocols, summaries, and presentations supporting experimental results
• Collect, maintain, and organize primary data for timely analysis in accordance with company policy
• Mentor and inspire team members as a tireless champion of bringing lifesaving cellular therapies to people in need
Qualifications and Skills:
• Ph.D. with 5+ years of experience or M.S. with 10+ years of experience in the relevant biotechnology or pharmaceutical industry
• Strong expertise in gene editing primary human immune cells using viral and non-viral gene delivery methods
• Extensive knowledge in generating and analyzing viral vectors (lentivirus, retrovirus, and/or AAV)
• Deep understanding and expertise in CRISPR knock-in/knock-out editing techniques or similar technologies
• Expertise in methods to characterize genetically modified cells including flow cytometry, microscopy, molecular/biochemical assays (NGS, RNA/DNA, qPCR, ELISA, western), in vivo models
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities; able to work independently and within a team; have a “do-what-it-takes” attitude
• Strong desire to be part of growing company and to make an impact on pipeline product development
• Excellent interpersonal, verbal, and written communication skills and record-keeping ability
Office/Lab Manager
Deverra Therapeutics is seeking a motivated and experienced Office/Laboratory Manager to manage the day-to-day operations for our laboratory and office. This key role will help to ensure the office and laboratory operations run as efficiently as possible. We’re looking for a proactive, self-starter with a high-level of professionalism. This person will collaborate with staff on decision-making regarding office and lab supplies, lab space planning, equipment maintenance and utilization, and waste stream. The candidate will advocate for a safe workplace and serve on the health and safety committee. This is a full-time position reporting to the Process Development Scientist, and is located in Seattle, WA.
Responsibilities:
Office Management
• Manage office equipment and inventory, general office supply inventories, and office cleanliness and general maintenance
• Initiate and be the point of contact for facility service requests and communication with building owners
• Provide main reception coverage for arrival of guests and deliveries
• Order and maintain the stock of kitchen supplies
• Onboard new employees for general safety training
• Receive and distribute mail
• Work with finance department to manage and maintain office budget
• As able, help with planning of meetings: all company, advisory, other company meetings
Laboratory Management
• Order lab supplies, maintain electronic records of purchase requisitions and orders
• Receive shipments, manage stock room and supplies
• Ship materials when needed
• Ensure laboratory equipment is calibrated, serviced, maintained, and functional
• Oversee biohazard and chemical waste storage and disposal
• Be the point of contact for vendors (lab coats, gas cylinders, dry ice, biohazard waste storage and disposal, etc.)
• Participate in the EH&S committee and advocate for a safe workplace
• Maintain MSDS, current chemical inventory, check eye wash and shower stations regularly
• Maintain liquid nitrogen, -80°C, -20°C freezers, and refrigerators
• Perform other lab organizational tasks as required
Qualifications and Skills:
• High School Diploma or GED required; Bachelor’s degree strongly preferred
• At least 5 years of experience in life sciences, with 3+ years’ experience managing a Biotechnology lab and working in Biological Safety Level 2 environments
• Experience managing biotechnology lab instrumentation and supplies
• Familiarity with biohazard and chemical waste management and lab safety
• Strong organizational skills, meticulous attention to detail, outstanding critical and creative thinking and problem-solving skills with the ability to provide solid rationale for recommendations
• Excellent verbal and written communication skills and record-keeping ability
• Exceptional interpersonal skills – must be able to successfully build relationships and provide a positive experience for colleagues, senior leadership, vendors, visitors, etc.
• Must be able to work in a collaborative team environment as well as operate independently to achieve results in a timely manner
• Proficient in MS Office Suite
• Must be able to lift 50 pounds