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Scientist/Sr. Scientist – In-Process Analytics and Characterization

November 29, 2022

Summary

The Scientist will support the development, transfer, bridging, monitoring, and execution of analytical methods in support of cell and gene therapy process development and analytical testing. This role presents a unique opportunity within the Process Development Department to grow diverse technical and intellectual skills in a dynamic and fast-paced environment. We are seeking an individual who is motivated by our mission, is highly organized, and a team player that is flexible to support a range of projects within a fast-growing organization. The ideal candidate will be able to function independently or in a team setting, be goal oriented, organized, highly communicative, and able to contribute to several projects.

Responsibilities

  • Conduct method development, transfer, bridging, monitoring, and execution to support Process Development with robust in-process analytics and characterization.
  • Under minimum supervision develop, optimize, and execute analytical methods to evaluate cell and gene therapy products.
  • Maintain analytical instrumentation and contribute to the organization of reagent stocks, instruments, and documentation.
  • Design, execute and interpret experiments to meet objectives.
  • Develop presentations and effectively communicate technical results to internal technical groups.
  • Maintain an up-to-date lab notebook.
  • Perform and coordinate analytical testing in support of process development, manufacturing, cGMP investigations, and product characterization.
  • Collaborate with a diverse team to develop products for cell and gene therapy applications.
  • Draft technical reports to comply with good laboratory practices.
  • Generate, analyze, and record high-quality data using documentation, and database tools.
  • Participate in the support of analytical activities including method qualification, data trending, troubleshooting, optimization, review and reporting.
  • Review, interpret and communicates data cross-functionally within the organization.
  • Attend, participate in, and present results at cross-functional team meetings.
  • Author reports and source documentation to support regulatory filings.

Qualifications

  • Bachelor’s Degree in Biology, Biochemistry, Cell biology, Molecular Biology, Immunology, or related discipline with >8 years of relevant industry experience, a Master’s degree with a minimum of 3 years industry experience, or a PhD preferred.
  • Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a Process/Analytical Development laboratory environment preferred.
  • Experience developing, transferring, and executing methods required.
  • Cell and gene therapy experience preferred.
  • Prior experience with in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and other common analytics highly desired.
  • Demonstrated ability to conduct and interpret experiments to meet technical objectives
  • Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal
  • A proven ability to collaborate with team members to complete projects in an efficient and timely manner.

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Research Associate – In-Process Analytics and Characterization

Summary

The Research Associate will execute in-process analytical testing for cell and gene therapy products with a multidisciplinary Process Development team.

Responsibilities

  • Execution of testing in development laboratory
  • Collaborate with a diverse team to execute assays for cell and gene therapy applications.
  • Conduct cell-based, molecular, and analytical assays
  • With supervision design, execute and interpret experiments to meet objectives.
  • Develop presentations and communicate technical results to internal technical groups.
  • Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices. and standard operating procedures.
  • Generate, analyze, and record high-quality data using documentation, and database tools.
  • Maintain laboratory records and contribute to laboratory organization and maintenance.
  • Independently execute analytical methods to characterize viral vector and cell therapy products.
  • Perform analytical testing in support of process development, cGMP investigations and product characterization.
  • Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams.

Qualifications

  • Bachelor’s Degree in Biology, Biochemistry, Molecular Biology, Immunology or related discipline
  • Minimum 1 years’ experience in cell and molecular biology, biochemistry, chemical engineering, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
  • Minimum 1 year’s of experience with in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and/or other common analytics highly desired
  • Demonstrated ability to conduct experiments to meet technical objectives
  • Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal
  • Ability to collaborate with team members to complete projects in an efficient and timely manner.
  • Capability and desire to work in a dynamic, fast-paced, innovative environment
  • Prior exposure to GMP, ISO regulated environment is a desirable

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Associate Director/Director of In-Process Analytics and Characterization

Summary

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from concept to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

The Associate Director/Director of In-Process Analytics will be responsible for providing leadership and management over a team of analytical scientists, in support of cell and gene therapy Process Development at the Center for Breakthrough Medicines. The AD/Director will be a key member of the Process Development leadership team and will be responsible for interfacing with Analytical Development, managing method transfer and performance to Process Development, and execution of methods. The AD/Director will be responsible for building and managing a team of cell and gene therapy scientists supporting in-process and characterization methods. A key focus of this position is to ensure fit-for-purpose methods and performance to support the high demand and rapid analytics required for Process Development as it relates to titer and impurity measurements, as well as developing a strong relationship with Analytical Development to drive continuous improvement and issue resolution.

Responsibilities

  • Lead a team of highly talented scientists and associates responsible for method transfer, execution, review, and reporting for cell and gene therapy products.
  • Provides technical and scientific leadership to the team responsible for in-process analytics and characterization methods including flow cytometry, plate-based assays (ie, ELISA and infectious titer), PCR-based assays (ie qPCR, dPCR, ddPCR), and other common analytics.
  • Transfer, bridge, monitor, and optimize analytical methods and support all related documentation (test methods, SOPs, protocols, reports)
  • Interface with key stakeholders including Process Development leads, Program Leadership, Analytical Development, and clients to ensure efficient and effective communication and knowledge exchange occurs as well as the establishment of necessary processes, procedures, and systems
  • Responsible for managing the professional development of direct reports, with plans for future expansion.
  • Execute on the cell and gene therapy strategy, in alignment with all CBM operations and support functions
  • Establish and monitor performance against established KPIs, internal metrics and trends to ensure the department performance against Safety, Compliance, Technical Trending and Delivery.
  • Accountable for scientific development and mentoring of scientists within reporting line
  • Fostering a culture of scientific rigor and continuous improvement
  • Ensure compliance with The Center for Breakthrough Medicines values and policies
  • Evaluate risks and opportunities with Management and drive strategic outcomes for the business.
  • Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems. Conducts employee performance appraisals in a timely and objective manner. Monitors the growth and career development of direct reports.
  • Ensure quality and assists Quality Assurance in maintaining all technical and regulatory requirements.
  • Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.
  • Represent the Company to customers, visitors, community organizations, local/state and governmental authorities, unions, industry associations and regulatory agencies.

Qualifications

  • Ph.D. in relevant field with 8+ years of cell biology laboratory experience or M.S. degree with 10+ years of relevant experience is preferred
  • Strong background and subject-matter expertise in process analytics and characterization required.
  • Experience managing a large team of full-time scientists, supporting multiple projects, and fostering a culture of innovation, teamwork, performance, and trust, with >2 years of people management experience is required.
  • >5 years of biotechnology or relevant industry experience is required.
  • Demonstrated experience transferring, bridging, training staff, and monitoring method performance.
  • Experience with cell-based functional bioassay techniques, including advanced cell culture techniques, plate-based spectrophotometer assays, ELISA, flow cytometry, RT-PCR, reporter cell lines, imaging techniques, biostatistical analysis tools.
  • Strong management/leadership skills and demonstrated ability to lead a group of scientists to deliver on objectives in defined timelines is required.
  • Independent, self-motivated, and innovative and the ability to excel in a goal-oriented, multifaceted and fast-moving team environment are required.
  • Outstanding communication, organizational and leadership skills, with a successful track record of collaborating with cross-functional scientific teams is required.
  • Capable of multi-tasking but with attention to detail, working on multiple projects, while delivering on objectives and budget

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Project Manager

November 14, 2022

Summary

The Project Manager, Process Development is a hands-on, cross-functional leader with a passion for driving results in a dynamic customer-focused environment. This key leadership position is accountable for operational project leadership of internal projects that have a focus on departmental enhancements as it relates to strategic business models, metric driven decisions, operational capacity, and organizational assessments, and more.

The Project Manager should come from a scientific background, have working business savvy on management and models to track departmental health, and be familiar with the business of a CDMO and how internal departments need to operate to be successful in that industry (both short-term issue resolution as well as long-term objective planning).

As a working manager, this coach and leader is often the face of the projects driving project meetings and actions forward to meet project objectives. Relationship building, timeline management, and ability to operate independently to overcome challenges will be critical.

Responsibilities

  • Provides operational leadership to cross-functional teams for internal projects supporting the Process Development department as well as the greater CBM organization.
  • Work with business unit leaders to understand current and future technology, capability, and capacity needs – decisions rooted in metrics and strategic pipeline projections.
  • Work with strategy leadership to identify, manage, prioritize, and govern strategic technology opportunities.
  • Coordinate and manage external partnerships, sponsored research, and M&A opportunities.
  • Work with R&D leadership to manage, support, and govern internal technology development initiatives.
  • Work with commercial leadership to coordinate strategic initiative conversions to CBM product and marketing efforts.
  • Ensures collaboration with appropriate team members across different functions for driving business decisions

Qualifications

  • Bachelor’s degree in a scientific discipline required; Master’s degree preferred
  • 7+ years of related pharmaceutical, biotech, CDMO, or related experience required, including relevant experience in laboratory services, business development, and strategy.
  • 3+ years of project management experience managing multi-disciplinary project teams in a service business strongly preferred.
  • Ability to work proactively and independently with a high level of business savvy towards prioritization of projects and initiatives making decisions founded strategic objectives.
  • Ability to develop operational methodologies for strategic planning towards long-term CBM goals.
  • Ability to forge strong relationships with internal and external business partners to accomplish objectives.
  • Ability to communicate at all levels and across all functions.
  • Lean Six Sigma or formal A3 training strongly desirable.
  • 2 years of prior supervisory or managerial experience preferred.
  • Advanced formal training, degree or certification(s) preferred.
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Senior Scientist

November 11, 2022

Summary

This role is responsible for planning, performing, analyzing, summarizing, reporting, and presenting experimental results related microbial fermentation and purification process development.

The ideal candidate will help design and startup a nucleic acid process development laboratory to support plasmid DNA production and mRNA synthesis. The scientist will develop a platform microbial fermentation process and subsequent downstream purification at both the laboratory and pilot scale. Experience in Microbial Fermentation Upstream and/or Purification Process development and optimization is a requirement.

This position works closely with internal and external stakeholders to deliver technical documents such as reports, protocol, and data reviews. The primary responsibility of this candidate is to develop a scalable end to end plasmid production platform. The scientist will also collaborate with both external and internal stakeholders to support ancillary activities such as analytical testing, cell banking, process scaleup, and technical transfer.

In addition to the technical skills required (plasmid process development, scale-up, and production), this role authors and reviews technical protocols and reports, drafts batch records and SOPs. The ideal candidate will successfully demonstrate upstream and downstream process development, scaleup, and analytics. Personal attributes including independent thinking, having a self-starter mindset, and strong collaboration skills are required. The final level of this position will be set according to candidate experience and qualifications.

Responsibilities

  • Designs and implements microbial strategies for upstream and downstream process development
  • Hands-on work in the developing, executing, and optimizing of upstream (fermentation, scale-up, characterization) and downstream (centrifugation, chromatography, and tangential flow filtration) unit operations for plasmid production
  • Support technology transfer into GMP manufacturing
  • Works closely with external partners on appropriate process and characterization studies to enable manufacturing
  • Authors and reviews development and process protocols, reports, and batch records
  • Supports analytical method development, qualification, transfer, and associated protocols/reports as needed
  • Assists with product quality attribute assessment and scoring to identify critical quality attributes (CQA)
  • Supports fermentation upstream and/or downstream process development activities
  • Traditional hours are expected, but will require occasional night, holiday, or weekend work in accordance with laboratory schedule
  • Potential responsibility to lead a small team

Qualifications

  • PhD in chemical engineering, microbiology, biochemistry, biotechnology, biology, or related field with 6+ years of industry-related experience; or M.S. with 8+ years; or BS with 10+ years of related industry experience
  • Ability to lead a cross-functional team to deliver on programs. Management experience is a plus but required
  • Experience in plasmid and novel nucleic acid processes and technologies
  • Experience in molecular biology, plasmid design and elements, and manufacturing processes, specifically, transformation, cell banking, production, purification, and storage
  • Knowledge and experience in fermentation, purification, and analytics
  • Proficient with large-scale (50L) fermentation and purification processes
  • Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
  • Project-management skills and ability to work successfully with contracting laboratories and manufacturing facilities
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Demonstrated ability to maintain detailed execution records and perform data analysis
  • Knowledge or experience with viral vector manufacturing in the biotech industry
  • Expertise in microbial upstream and downstream process development, such as large-scale (50L) fermentation, depth filtration, tangential flow filtration, chromatography column purification
  • Experience with Design of Experiment (DOE)
  • Experience with microbial production, purification, and characterization
  • Strong communication skills (e.g., clear and concise) and a team player
  • Strong time and project management skills
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution

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Scientist/Engineer, MSAT Process Development

November 7, 2022

Summary

The Scientist/Engineer is responsible for assisting in the development and implementation of manufacturing processes used to manufacture client cell and gene therapy products at the Center for Breakthrough Medicines. This individual will work with internal and external organizations to plan, execute, and document studies/assessments to support GMP operations stand-up and maintenance, yield process improvements, reduce errors, and support investigations. The Scientist/Engineer will provide ownership and management for process and characterization knowledge related to the GMP production of advanced therapy products.

Additionally, this individual will be responsible for supporting the collection and interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements. This position will involve hands-on troubleshooting of the manufacturing processes and writing of technical reports.

Other responsibilities include providing assistance in manufacturing led investigations through partnerships with Quality and other business units at the site. Work to determine root cause, implement a solution and a verification check to ensure the fix was effective.

The Scientist/Engineer will be responsible for owning a portion of the process, planning ahead to avoid delays, good documentation practices, and participating in continuous improvement and operational excellence projects to help drive efficiency, while error proofing the process.

Responsibilities

  • Serving as a scientific and technical representative for process-related issues at the facility.
  • Partnering with Process Development and Operations to meet the production schedule, ensure product supply and uphold quality standards.
  • Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Implementing potential process improvements in conjunction with operations.
  • Participating in start-up efforts of new equipment, software or processes in manufacturing.
  • Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes
  • Providing technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
  • Utilizing small-scale production processes and using scaled-down lab processes to enable process troubleshooting
  • Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing
  • Assist in implementing opportunities for operational excellence and continuous improvement
  • Partner with Quality to ensure a quality and compliant manufacturing environment
  • Assist the technical operations team to resolve any issues related to production

Qualifications

  • Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field
  • Excellent oral and written communication skills.
  • 2 – 5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish
  • Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements
  • Strong technical writing ability
  • Proven ability to effectively lead and participate on teams
  • Entrepreneurial experience dealing with customers in product development
  • Working knowledge of cGMPs related to the production of microbial therapeutics
  • Extremely high levels of flexibility, initiative, solution-orientation, and tenacity.
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Manager/Principal Scientist, Cell Therapy Process Development

August 16, 2022

Summary

This role is responsible for leading a team tasked with the tech transfer, process development, and process characterization of cell therapies. This role reports to the Director of Cell Therapy Process Development and will work in close collaboration with the Technology Transfer, MSAT, Analytical Development, Drug Product, and Manufacturing teams to execute process characterization and IND/BLA enabling studies. Execution of this role requires a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaborative skills. This position requires extensive knowledge of late-phase manufacturing, process characterization, IND and BLA enabling study design, and other activities as deemed necessary by program leadership.

Responsibilities

  • Oversee the strategy, planning, analysis, and execution of studies designed to drive successful process development and process characterization of cell therapies.
  • Accountable for technology transfer of early or late phase cell therapy programs.
  • Utilize prior experience to identify and forecast phase specific process development and process characterization strategies including a scale-down model strategy.
  • Technical authoring of documents critical to tech transfer, process development, and process characterization of cell therapy programs.
  • Demonstrate effective leadership to drive product development while adhering to FTEs/budget, regulatory standards, and company goals.
  • Assess risk and opportunity to identify solutions to optimize to achieve departmental objectives while mitigating potential risks using effective cross-departmental collaboration.
  • Provide expert scientific advice to client and cross-functional teams for successful execution of planned development studies.
  • Communicate department goals, expectations, and capabilities to internal team members, and external vendors or clients.

Qualifications

  • A minimum MS / BS and 8+ years’ experience or PhD and 5+ years’ experience.
  • Extensive knowledge and experience in designing process development and process characterization studies of cell therapy or biologics manufacturing processes.
  • Excellent communication and leadership skills are required to support client-based programs.
  • Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies.
  • Demonstrated experience with tech transfer, process development, process characterization and regulatory approvals (IND and BLA)
  • Thrives in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Able to communicate project status, risks, needs, and data/information and its practical application to junior staff and management
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Principal Scientist/Associate Director, Drug Product Formulation Lead

March 14, 2022

Summary

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

Cell and Gene Therapies Drug Product Development (CGDPD) is a department within a Process Development Division in Center of Breakthrough Medicines. CGDPD is responsible for drug product formulation, process development and tech transfer for manufacturing of various modalities of allogeneic and autologous cell and gene therapies. CGDPD represents a unique diverse team of scientists and engineers driving end-to-end Drug Product development efforts in advanced therapies. The Principal Scientist/ Associate Director, DP Formulation will play a critical role in leading formulation development team, driving formulation screening, robustness, characterization, and analytical development in support for cell and gene therapy DPs. This role encompasses development of de-novo early-stage formulations as well as late-stage BLA work packages in support of translation to commercialization of clients’ product. The successful candidate will be responsible for driving various activities, including, but not limited to described below:

Responsibilities

  • Design and drive formulation development and DP design for clients and internal efforts.
  • Drive innovations through evaluation of novel cell and gene therapy formulation approaches, identification of new instrumentation and testing of emerging platforms.
  • Plan, execute and interpret formulation development experiments for various modalities of cell therapies such as CAR-Ts, CAR-NKs, TILs, Tregs, iPSC and others.
  • Plan and execute studies to understand and control interaction of DP with product contact material surfaces in manufacturing and clinical settings.
  • Author/review technical reports, data summaries and CMC related documents required for regulatory submissions.
  • Design and support container closure selection and development for cell and gene therapies.
  • Contribute to technical discussions aimed at resolution of issues with suppliers, processes, and deviations
  • Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program
  • Ability to work under pressure and deliver high quality clinical trial and manufacturing batches.
  • Works closely with process development and tech transfer team to ensure that manufacturing processes yield the highest possible DP quality profile.
  • Support with timely presentations and updates as necessary to management
  • Other duties as needed.

Qualifications

  • Thorough understanding of formulation development, biophysical characterization, and stabilization principles.
  • Familiarity with clinical preparation and administration procedures.
  • Experience with authoring regulatory documents for IND/IMPDs and BLA
  • Experience with formulation development of cell and gene therapies is a plus.
  • Understanding and experience with cell therapy cryopreservation is a plus.
  • Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
  • Attention to detail and quality are critical to success.

Education & Experience

Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 5+ years’ experience, MS with 7+ years, BS with 9+ years.

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Senior Scientist, Cell Therapy Drug Product Development

Summary

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Cell and Gene Therapies Drug Product Development (CGDPD) is a department within a Process Development Division in Center of Breakthrough Medicines. CGDPD is responsible for formulation, process and device development for various modalities of allogeneic and autologous cell and gene therapies. CGDPD represents a unique diverse team of scientists driving end-to-end Drug Product development efforts in advanced therapies. The Senior Scientist role will be responsible for advancing CBM expertise in cell therapy manufacturing processes and tech transfer for both autologous and allogeneic drug products. He/she will play a critical role in progressing technology transfer, process development and associated manufacturing of clinical and commercial cell therapy drug products.

Responsibilities

  • Drive innovations through evaluation of novel cell therapy process workflows, identification of new instrumentation and testing of emerging platforms.
  • Plan, execute and interpret process development experiments for various modalities of cell therapies such as CAR-Ts, CAR-NKs, TILs, Tregs, iPSC and others.
  • Lead process development studies to determine and characterize process parameters associated with preparation of cell therapy drug products, including formulation, filling, cryopreservation, and inspection.
  • Design and support container closure selection for autologous and allogeneic cell therapies.
  • Contribute to technical discussions aimed at resolution of issues with suppliers, processes, and deviations
  • Prepare technical reports and present the finding to colleagues and management
  • Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program
  • Follow general laboratory safety and training requirements

Qualifications

  • Experience with large molecules or novel modalities is required.
  • Familiarity with clinical preparation and administration procedures
  • Experience with authoring regulatory documents for IND/IMPDs
  • Experience with formulation development of cell and gene therapies is a plus.
  • Understanding and experience with cell therapy cryopreservation is a plus.
  • Organizational skills to drive and execute process development studies
  • Working knowledge in DOE, data and statistical analysis is preferred
  • Ability to work collaboratively but independently

Education & Experience

  • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 1+ years’ experience, MS with 5+ years, BS with 7+ years.

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