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.

Summary

The Center for Breakthrough Medicines is seeking an Operations Scheduler to provide visibility of all laboratory operations (client and internal) within the Process Development (PD) group. This critical role will develop and maintain a scheduling tool that will be used to track all necessary activities to successfully execute work for the entire department. This will entail close interactions with upper management, laboratory leads, and supporting groups to ensure that all activities are scheduled, updated, and verified completion daily and adjust as actions shift. This will entail evaluations of timetables of simultaneous operations across multiple labs and multiple buildings, analyze staff training and availability, as well as close consultation with lab leads to ensure adequate coverage and planning for all activities. The ideal candidate will need to be very detail oriented and organized with information and be able to quickly implement and communicate effective plans using sound judgement.

Responsibilities

• Develop and maintain a schedule planning tool that is geared towards providing effective visibility and direction for the lab staff to execute on internal and external business objectives
• Responsible for maintenance of this tool to ensure that all activities are performed as expected and daily activities are confirmed as complete according to schedule
• Works closely with lab management for staff scheduling, training analysis, and evaluation of readiness to execute work as expected. Emphasis on forward-thinking against schedule to proactively identify staff shortages, overlapping equipment/labs/activities, or other scheduling issues for proactive resolution
• Responsible for attending all team huddles to convey pertinent schedule related updates as appropriate
• Effectively communicates with leadership plans and changes as they arise
• Responsible for working closely with Supply Chain Planners to evaluate client program material orders and lead times to ensure operational schedules can be met
• Works closely with Lab Operations personnel of asset installs, ordering, maintenance, etc that may impact scheduling operations
• Manage own time, professional development, and be accountable for quality results
• Follows all company environmental, health and safety policies, procedures, and guidelines, and conducts work in a safe manner
• Perform other related duties as assigned

Qualifications

• B.S./A.S./M.S. in a related scientific field required
• 4+ years’ experience in a laboratory setting ideally within the pharmaceutical/med device/biotech production industry
• Strong computer skills (MS Project, excel, etc)
• Knowledge of GxPs, SOPs, QA compliance enforcement
• Strong communicator that can accurately communicate complex plans to cross functional teams
• Strong organizational skills, ability to multitask, work independently, and forward think required
• Experience with SAP, eLIMS, ERP, MRP, or other similar software strongly desired

Summary

Center for Breakthrough Medicines is seeking a Laboratory Technician to provide laboratory support for scientists in the Process Development laboratory areas of the organization. The Laboratory Technician supports the execution of cell and gene therapy process development. The Lab Tech will work on interdisciplinary teams, implement process improvements, and participate in process troubleshooting. Responsibilities will include a variety of tasks including but not limited to vendor management, equipment maintenance, buffer preparation, sample management and other key support functions to enable successful execution of process development team.

Responsibilities

• Operates and responsible for autoclave, parts washer/glassware washer, and other general laboratory equipment
• Prepares certain equipment ahead of scientific teams needing for operations. This may include cleaning of equipment, performance of standardize checks, staging materials, etc
• Reviews documentation daily (cleaning logs)
• Manages onsite vendors to ensure business demands are met (cleaners, gowning, and biowaste vendors)
• Prepares buffers, tubing assemblies, and other items to prepare for an experiment
• Supports equipment management practices involving movement, systematic management, installation, routine maintenance, etc
• Executes work based on Standard Operating Procedures (SOPs) or Work Instructions (WIs). This individual may be asked to revise or develop these documentations as needed
• Manage own time, professional development, and be accountable for quality results
• Follows all company environmental, health and safety policies, procedures, and guidelines, and conducts work in a safe manner
• Ensures labs are in a constant state of audit readiness
• Perform other related duties as assigned

Qualifications

• B.S./A.S. in a related laboratory field preferred; GED or equivalent required
• 2+ years’ experience in a laboratory setting within the medical device/pharmaceutical industry (or similar) with knowledge of lab equipment preferred
• Knowledge of GxPs, SOPs, QA compliance enforcement

Summary

This role is responsible for planning, performing, analyzing, summarizing, reporting, and presenting experimental results related to Upstream Process development and optimization. This position works closely with external contract development and manufacturing partners. The scientist will also have oversight of external manufacturing of master and working cell banks as well as viral seed stock production, viral vector production, and scale-up. This role authors and reviews technical protocols and reports, drafts batch records and SOPs. The ideal candidate should have successfully demonstrated viral vector process development, production, and analytics, as well as personal attributes including initiative, independent thinking and collaboration skills.

Responsibilities

• Designs and implements viral vector strategies for upstream and downstream process development
• Hands-on work in the developing, executing, and optimizing of upstream (cell culture, scale-up, characterization) unit operations for viral vector production
• Support technology transfer into vector manufacturing
• Works closely with external partners on appropriate viral vector process and characterization studies to enable manufacturing
• Authors and reviews viral vector development and process protocols, reports, and batch records
• Potential responsibility to lead a small team

Qualifications

• Knowledge and experience in viral vector production, purification, and analytics
• Proficient with large-scale mammalian cell culture and suspension cells
• 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 virus upstream and downstream process development, such as large-scale suspension cell culture, bioreactors, tangential flow filtration (TFF), column purification
• Experience with Design of Experiment (DOE)
• Experience with virus characterization, such as replication-competent virus (RCV), infectious virus bioassays and viral particle assays
• Experience with viral vector 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
• Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
• Takes ownership of the assigned project, consulting with management and peers
• Able to understand and interpret data/information and its practical application

Education & Experience

• PhD in virology, virus bioengineering, gene/cell therapy, or related field with 2+ years of industry-related experience; or M.S. with 10+ years of related industry experience

Summary

Manufacturing Science and Technology (MSAT) is a department within the Technology Development organization at the Center of Breakthrough Medicines. MSAT provides technical support for enabling readiness, robustness and GMP compliance of manufacturing processes for Cell and Gene 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 viral vector drug substance manufacturing SMEs in support of Process Development and Manufacturing organizations.
• Contribute to overarching Technology Development goals to ensure the effective integration of process knowledge, robustness, and right first time priciples into manufacturing operations.
• Work closely with Manufacturing Operations to ensure that drug substance manufacturing is 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 manufacturing processes from early clinical phase through and commercial manufacturing lifecycle.
• 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 CAPA.
• 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/or cell culture derived viral vectors.
• Demonstrated leadership of a team in a fast paced/dynamic environment.
• 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.

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, tech transfer and support 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. Drug Product Manufacturing Science and Technology (DP MSAT) is a team within a Cell and Gene Therapies Drug Product Development in Center of Breakthrough Medicines. DP MSAT provides technical support for enabling readiness, robustness and GMP compliance of fill/finish manufacturing processes for gene and cell therapy products. Associate Director of DP MSAT ensures that formulation, fill/finish and cryopreservation steps in drug product manufacturing processes are optimized, scalable and compliant through strong collaboration and guidance from Drug Product Process Development, Quality and Manufacturing teams

Responsibilities

· Lead and coordinate drug product manufacturing effort between Process Development and Manufacturing organizations.

• Contribute to overarching Process Development goals by ensuring the effective integration of process knowledge into manufacturing operations.
• Work closely with Manufacturing team to ensure that drug product operations are thoroughly supported by high quality process documentation (batch records, forms, SOPs), controlled processes and verified technology.
• Responsible for change control ownership, investigations, and other quality system deliverables.
• Support fill/finish manufacturing processes from early clinical phase through and commercial manufacturing.
• Design and ensure DP process control strategies, including execution of process risk assessment, justification of process parameters range, and criticality analysis.
• Collaborate with Cell & Gene Therapy Drug Product Development and Quality organizations to establish and maintain the control of the process.
• Accountable for DP process FMEA original drafting and revision through drug product life cycle.
• Leverage DP 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 DP manufacturing runs. Prevent and resolve issues taking place during production through use of process analytical technologies and product monitoring

Qualifications

• Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies and fill/finish of 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.

Education & Experience

• Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 7+ years’ experience, MS with 9+ years, BS with 13+ years

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. Director, Drug Product Development Head will play a critical role critical role in leading formulation, in-use stability and process development studies for clinical and commercial cell and gene therapy drug products. This role encompasses support of early phase development as well as late-stage BLA work packages in support of commercialization of clients’ products. The successful candidate will be responsible for driving various activities, including, but not limited to described below:

Responsibilities

• Manage a team of scientists and engineers to develop, optimize and implement formulation and manufacturing process for cell and gene therapy drug products.
• Drive innovations through evaluation of novel cell and gene therapy DP formulation and manufacturing approaches, identification of new instrumentation and testing of emerging platforms.
• Plan, oversee 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.
• Develop robust manufacturing process and scale up procedures for engineering and GMP DP batches by applying QBD approaches as per Health Authority requirements.
• 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.
• Lead 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 tech transfer team to make sure that DP manufacturing processes meets requirements of target product profile.
• Other duties as needed.

Qualifications

• Thorough understanding of formulation and process development for novel modalities.
• Proven track record in building and leading diverse development teams in innovator pharmaceutical companies and CDMOs is must.
• Experience with authoring regulatory documents for IND/IMPDs and BLAs
• 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 10+ years’ experience, MS with 15+ years, BS with 17+ years.