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Biomaterials Scientist/Engineer II

Summary

The Biomaterials Scientist/Engineer is a member of Materials Science and responsible for assisting in providing knowledge and expertise to ensure that materials performance is aligned with the specific intentions of the user, the regulations that dictate GMP practices and patient safety.This individual will assist in providing materials integrity, accuracy, and consistency across the CBM organizations that are involved in the use and transformation of materials in processes, as a drug product or in contact with the drug product, as raw and ancillary materials and intermediates or in materials selection, specification and source.

This individual will serve on multidisciplinary teams to affect the flow of materials and materials information from client to release for manufacturing.You will contribute to the definition, creation and defense of new materials specifications and participate in the investigation and vetting of their suppliers and manufacturers.You will provide materials expertise to internal organizations that require assistance in materials selection and compatibility.

Responsibilities

The biomaterials scientist/engineer will contribute to the development of a hybrid internal and external extractables and leachables (E&Ls) evaluation and testing program.You will be involved in all aspects of product and process development, tech transfer where biomaterials are involves and will be expected to apply your skills and knowledge more broadly across other CBM business units as required.You will review and author technical reports and the open literature to remain cognizant on current trends especially in C&GT and single use systems.You will author / contribute to risk assessments involving particulates and E&Ls and other aspects of materials science and engineering as required.

  • Responsibility focus:cell & gene therapy reagents and systems materials – materials of biological and non-biological origin,
  • Work in project teams to usher new materials through for use in GMP manufacturing insuring they are properly specified, characterized and aligned with their intended use.
  • Evaluate, codify and amass knowledge of all aspects of materials attributes, origin, use, storage, contact issues, viability, testing, knowledge of process use, biological functioning.
  • Establish C&GT knowledge of process (KoP) / materials relationships and serve as SME to members of materials science and other organizations as needed.
  • Provide or develop CBM-relevant expertise in biosurface stability and dynamics, particulate generation, extractables and leachables,
  • Develop predictive capabilities to streamline evaluation of complex processes and products
  • Work with other material science members to develop predictive materials behavior tools to aid in the evaluation of complex assemblies or configurations where absence or difficulty in acquiring empirical data exists.
  • Contribute to the evaluation of material, material supplier & manufacturer, sampling and testing plans of critical biomaterials and attributes.
  • Where necessary obtain empirical data or perform tests or arrange for internal or external testing of materials to ensure functionality, performance and compatibility.
  • Support transfer of knowledge among CBM organizations.
  • Provide direct support to drug product and drug process development systems, support multiple projects at different stages of development.
  • Serve as a the Materials Science core team member for client sponsored programs.
  • Contribute to the overall smooth flow of materials and materials information throughout the CBM.

Education & Experience

Education

  • Advanced degree (MS or Ph.D.) or equivalent experience in biomaterials, biology, materials science or engineering or relevant area of scientific research
  • Strong written and oral communication skills
  • Experience with cell and gene therapy and or biopharm materials and products
  • Experience with materials characterization and analytical instrumentation
  • Microsoft Excel expertise and proficient in the MS Office / Windows environment

The following experiences are a plus:

  • Experience working in a burgeoning entrepreneurial environment
  • Knowledge of the USP, and Eu. Ph., Jp. Ph., …, ISO standards
  • Experience with extractables & leachables, biocompatibility, toxicological and particulate assessment (ISO 10993)
  • Knowledge of materials modeling and properties computation
  • Analysisand interpretation of data, with use of data analysis tools (JMP, Minitab, … )
August 9, 2022

Materials Data Scientist/Engineer

Summary

The Materials Data Scientist/Engineer is a member of Materials Science and responsible for assisting in providing knowledge and expertise to ensure that materials performance is aligned with the specific intentions of the user, the regulations that dictate GMP practices and patient safety.This individual will assist in providing materials integrity, accuracy, and consistency across the CBM organizations that are involved in the use and transformation of materials in processes, as a drug product or in contact with the drug product, as raw and ancillary materials and intermediates or in materials selection, specification and source.

This individual will serve on multidisciplinary teams to affect the flow of materials and materials information from client to release for manufacturing.You will contribute to the definition, creation and defense of new materials specifications and participate in the investigation and vetting of their suppliers and manufacturers.You will provide materials data expertise to internal organizations that require assistance in materials selection and compatibility.

The Materials Data Scientist/Engineer will support the raw materials program at the CBM. The individual will be a key member of the materials science team supporting materials data flow throughout the CBM.You will work with members of Process Development, Program Management, Information Technology, Testing and Analytical Services and Quality Control and Regulatory business units.

Responsibilities

Primary duties include but are not limited to:

  • Supporting the preparation and review of raw materials data, including specifications, testing plans and risk assessments, for the manufacture of C&GT products.
  • Compiling data for the specification, testing and sampling of raw materials.
  • Contributing supplier and manufacturer database development for raw materials and consumables.
  • Participate in the writing and revise SOPs as it pertains to materials information data.
  • Contribute data to protocols and reports for raw material qualification.
  • Contribute to creation of routines for the flow of materials data from sources to end users.
  • Review manufacturers’ and suppliers’ product specification data and certificates of compliance and analysis for consistency and the materials attributes needed for materials intended uses
  • Contribute to the writing and revisioning of SOPs as it pertains to data specifying, acceptance, testing strategy and disposition of raw materials

Education & Experience

Required Qualifications:

  • Minimum of bachelor’s degree in technical field with preference in chemistry, materials, biological/biopharm science, pharmacy
  • Knowledge of in materials/chemical name discrimination and identification
  • Knowledge of materials qualities and discernment of test for their attributes
  • Ability to author and review protocols, reports, and standard operating procedures
  • High level experience and proficiency with Microsoft Excel and data maintenance
  • Good written, verbal, and interpersonal skills to effectively interact with cross-functional teams.
  • Ability to manage multiple priorities and tasks in a dynamic environment
  • Ability to work in a team environment or independently with minimum supervision on day-to-day activities

Desirable Qualifications:

  • Experience with material specification and testing with preference in GMP environment.
  • Experience with FDA/GMP regulations with preference of USP, EP and ICH Guidelines.
  • Experience with compendial reviews for new and/or revised compendial requirements.
  • Experience in preparation of raw material specification documents and certificate of analysis.
  • Very high level of Microsoft Excel proficiency
  • Experience with SAP system.
  • 1 to 3 years working in GMP environment.

Biomaterials Scientist/Engineer

Summary

The Biomaterials Scientist/Engineer is a member of Materials Science and responsible for assisting in providing knowledge and expertise to ensure that materials performance is aligned with the specific intentions of the user, the regulations that dictate GMP practices and patient safety.This individual will assist in providing materials integrity, accuracy, and consistency across the CBM organizations that are involved in the use and transformation of materials in processes, as a drug product or in contact with the drug product, as raw and ancillary materials and intermediates or in materials selection, specification and source.

This individual will serve on multidisciplinary teams to affect the flow of materials and materials information from client to release for manufacturing.You will contribute to the definition, creation and defense of new materials specifications and participate in the investigation and vetting of their suppliers and manufacturers.You will provide materials expertise to internal organizations that require assistance in materials selection and compatibility.

Responsibilities

The biomaterials scientist/engineer will contribute to the development of a hybrid internal and external extractables and leachables (E&Ls) evaluation and testing program.You will be involved in all aspects of product and process development, tech transfer where biomaterials are involves and will be expected to apply your skills and knowledge more broadly across other CBM business units as required.You will review and author technical reports and the open literature to remain cognizant on current trends especially in C&GT and single use systems.You will author / contribute to risk assessments involving particulates and E&Ls and other aspects of materials science and engineering as required.

  • Responsibility focus:cell & gene therapy reagents and systems materials – materials of biological and non-biological origin,
  • Work in project teams to usher new materials through for use in GMP manufacturing insuring they are properly specified, characterized and aligned with their intended use.
  • Evaluate, codify and amass knowledge of all aspects of materials attributes, origin, use, storage, contact issues, viability, testing, knowledge of process use, biological functioning.
  • Establish C&GT knowledge of process (KoP) / materials relationships and serve as SME to members of materials science and other organizations as needed.
  • Provide or develop CBM-relevant expertise in biosurface stability and dynamics, particulate generation, extractables and leachables,
  • Develop predictive capabilities to streamline evaluation of complex processes and products
  • Work with other material science members to develop predictive materials behavior tools to aid in the evaluation of complex assemblies or configurations where absence or difficulty in acquiring empirical data exists.
  • Contribute to the evaluation of material, material supplier & manufacturer, sampling and testing plans of critical biomaterials and attributes.
  • Where necessary obtain empirical data or perform tests or arrange for internal or external testing of materials to ensure functionality, performance and compatibility.
  • Support transfer of knowledge among CBM organizations.
  • Provide direct support to drug product and drug process development systems, support multiple projects at different stages of development.
  • Serve as a the Materials Science core team member for client sponsored programs.
  • Contribute to the overall smooth flow of materials and materials information throughout the CBM.

Education & Experience

Education

  • Advanced degree (MS or Ph.D.) or equivalent experience in biomaterials, biology, materials science or engineering or relevant area of scientific research
  • Strong written and oral communication skills
  • Experience with cell and gene therapy and or biopharm materials and products
  • Experience with materials characterization and analytical instrumentation
  • Microsoft Excel expertise and proficient in the MS Office / Windows environment

The following experiences are a plus:

  • Experience working in a burgeoning entrepreneurial environment
  • Knowledge of the USP, and Eu. Ph., Jp. Ph., …, ISO standards
  • Experience with extractables & leachables, biocompatibility, toxicological and particulate assessment (ISO 10993)
  • Knowledge of materials modeling and properties computation
  • Analysisand interpretation of data, with use of data analysis tools (JMP, Minitab, … )
July 6, 2022

Associate Director/Director, Drug Substance, MSAT

Summary

Manufacturing Science and Technology (MSAT) is a department within a Process Development Division in Center of Breakthrough Medicines. MSAT provides technical support for enabling readiness, robustness and GMP compliance of manufacturing processes for gene and cell therapy products. Associate Director/Director of MSAT, Drug Substance ensures that cell culture, cell selection, purification, isolation and formulation/bulk fill steps in drug substance manufacturing processes are optimized, scalable and compliant through strong collaboration and guidance from Process Development, Quality and Manufacturing teams.

Responsibilities

  • Lead a team of Engineers and Scientists, who perform as drug substance manufacturing SMEs in support of Process Development and Manufacturing organizations.
  • Contribute to overarching Process Development goals to ensure the effective integration of process knowledge into manufacturing operations.
  • Work closely with Manufacturing team to ensure that drug substance operations are thoroughly supported by high quality process documentation (knowledge transfer, batch records, forms, SOPs), controlled processes and verified technology.
  • Responsible for change control ownership/assessment, investigations, product quality impact assessments, and other quality system deliverables.
  • Support viral vector and/or cell therapy manufacturing processes from early clinical phase through and commercial manufacturing.
  • Design and ensure DS process control strategies, including execution of process risk assessment, justification of process parameters range, and criticality analysis.
  • Collaborate with Cell & Gene Therapy Drug Substance Development and Quality organizations to establish and maintain the control of the process.
  • Accountable for DS process FMEA authoring and revision through drug substance life cycle.
  • Leverage MSAT team’s technical knowledge and expertise to lead investigations from initial analysis, root cause determination to establishment and execution of effective CAPAs.
  • Provide on-the floor support during engineering and GMP DS manufacturing batches. Prevent and resolve issues taking place during production through use of process analytical technologies and product monitoring.

Qualifications

  • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 10+ years’ experience, MS with 13+ years, BS with 16+ years
  • Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies and cell culture derived viral vectors.
  • Robust experience in technology transfer from development into a cGMP Manufacturing.
  • Direct experience of working in quality systems, authoring and review of GMP and technical documents.
  • Previous experience in facility commissioning, equipment qualification and maintenance is highly preferred.
  • Thorough understanding of GMP requirements and their relation to process operations.
  • Demonstrated project management capabilities.
  • Self-motivated with strong interpersonal and organizational skills.
  • Emotional intelligence to communicate and interact internally and with clients to drive program deliverables.

May 3, 2022

Principal/Senior Scientist, Cell Therapy Tech Transfer Lead

Summary

Center for Breakthrough Medicines is seeking a highly motivated Principal/Sr. Scientist, Tech Transfer Leads to provide leadership and guidance across the Cell Therapy Process Development team and to direct the tech transfer activities from Client to Process Development to Manufacturing and Client to Manufacturing. The ideal candidate should be experienced in advanced cell therapies technology transfer, cGMP operations, and comfortable working in a fast-paced, entrepreneurial environment with broad responsibilities and opportunities.

Responsibilities

  • Serve as lead, subject matter expert in advanced cell therapy Product and Processes, at all stages of development including process development, tech transfer, technical operations, and regulatory filings
  • Collaborate effectively with cross-functional teams including Process Development, Project Management, MSAT, Supply Chain and Manufacturing, as well as the Client to accomplish deliverables for technology transfer.
  • Lead on robust process tech transfer plans, detailed process flow diagrams (PFD), bill of materials (BOM), manufacturing batch records, and campaign summary reports
  • Identify and implement potential process improvements in conjunction with manufacturing and MSAT team.
  • Serve as a scientific and technical lead for tech transfer related issues and investigations.
  • Contribute to cell therapy process development laboratory activities

Qualifications

  • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 5+ years’ experience, MS with 7+ years, BS with 9+ years
  • Demonstrated experience with tech transfer, process development, scale-up, pilot, GMP technical operations, and regulatory approvals (IND and BLA)
  • Hands-on experience with most equipment and unit operations of cell therapy processes development
  • Strong communication skills and emotional intelligence to communicate and interact internally and with customers to drive program deliverables
  • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient

March 29, 2022

Principal Scientist/Engineer, MSAT Process Development

Summary

The Principal Scientist/Engineer is responsible for assisting development and leading 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 Principal 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 leading 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 both individually and through a team.

Other responsibilities include providing leadership 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 Principal 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 leader for process-related issues at the facility.

·Driving partnership 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.

·Ensuring documentation changes/updates to manufacturing processes occur and works with manufacturing, engineering and validation to implement those changes.

·Providing technical/scientific leadership 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

·Lead tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing

·Lead implementing opportunities for operational excellence and continuous improvement

·Partner with Quality to ensure a quality and compliant manufacturing environment

·Lead 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.

·6 – 10 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 cell and geneof microbial therapeutics

·Extremely high levels of flexibility, initiative, solution-orientation, and tenacity.

March 24, 2022

Principal Scientist/Associate Director, Drug Product Formulation Lead

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.

March 14, 2022

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.

Scientist/Engineer, MSAT Process Development

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.
February 1, 2022

Sr/Scientist, Cell Therapy & Gene Editing, Process Development

Summary

This role is responsible for planning, executing, analyzing, reporting on, and presenting on studies related to gene editing and cell therapy process development. This position works closely with the Cell Therapy Process Development leader, and the client to understand, discuss, and deliver against defined objectives. This role authors and reviews technical protocols and reports, and procedures. The ideal candidate should have a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaboration skills.

Responsibilities

  • Independent functioning as a bench scientist, capable of planning, executing, analyzing and reporting on studies related to gene editing and cell therapy process development.
  • Independent manager of work, including sourcing of materials, use of equipment and space, time management, problem solving, and risk identification/escalation to meet objectives.
  • Strong team member and contributor to overall cell therapy process characterization, development and validation activities individually or in a team
  • Design and validate novel strategies for autologous or allogeneic cell therapy platforms.
  • Capability to be hands-on in laboratory work in developing, executing, and optimizing of cell therapy unit operations
  • Authors, and reviews process development study protocols, reports, and batch records
  • Collaborates with Analytical Development to meet testing needs
  • Works closely with clients and technical team on appropriate process and characterization studies to enable manufacturing
  • Leads product quality attribute assessment and scoring to identify critical quality attributes (CQA)

Qualifications

  • BS (5+ years’ experience), MS (3+), or PhD in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic cell therapy (iPSC, NK or T-cells) technologies and demonstrated laboratory proficiency
  • Extensive hands-on experience on gene editing technologies (CRISPR etc.) in human iPSC, NK, or T-cells and selection of edited clones & their characterization is required
  • Knowledge and experience in stem cells (iPSCs or MSCs) reprogramming, culture and differentiation into various cell types
  • Hands-on experience with most equipment and unit operations of cell therapy process development is highly preferred.
  • Expertise in operating cell culture bioreactors at development or pilot scale is plus.
  • 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
  • Flexible for occasional weekend work

Education & Experience

BS (5+ years’ experience), MS (3+), or PhD in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic cell therapy (iPSC, NK or T-cells) technologies and demonstrated laboratory proficiency

January 6, 2022