866-274-4009 Contact Us

Director of Analytical Development for Flow Cytometry/ Cell Biology Lab

Summary

The Director of Analytical Development for Flow Cytometry/Cell Biology will be responsible for providing senior leadership over the Flow Cytometry/Cell biology testing services supporting Cell and Gene TherapyPrograms at Center for Breakthrough Medicines.The Director will be a key member of the Testing Leadership team and will be responsible for leading the development new Flow Cytometry/Cell biology methods, transitioning, and validating GMP test methods from Analytical Development and other cross-functional groups, and CBM’s clients.The Director will be responsible for managing a team of Cell and Gene Therapy scientists that will be directly responsible for development and method transfers anddelivering results to our customers for complex characterization and product release methods.The Director will also be responsible for driving the strategy and execution of new analytical technologies and techniques to serve our clients, bringing cell and gene therapies from bench to bedside.

Responsibilities

  • Lead a team of highly talented scientists responsible for delivering testing for Cell and Gene Therapy Programs, with a focus on AAV, AV and LV
  • Lead development of a new Flow Cytometry testing platform at CBM for cell and gene therapy programs inAnalytical Development.
  • Provides technical and scientific leadership to the team responsible for validation and GMP Testing of Flow Cytometry/Cell biology assays supporting Cell and Gene Therapy Programs
  • Responsible for managing 10 – 20 Scientists 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.
  • Develops talent strategies and implements hiring, and broader talent issues and provides people-related decisions for a department/multiple teams within Testing and Analytical Services that cultivates innovative culture.
  • Actively lead the strategic direction and goals of the department
  • Build and foster relationships across the technical operations groups, Analytical Development Departments, contributing to projects and peer review when required
  • Responsible for ensuring quality, consistency and best practice within reporting line
  • Accountable for scientific development and mentoring of scientists within reporting line
  • Fostering a culture of scientific rigor and continuous improvement in line with the Innovation Performance and Trust (IPT) strategy at The Center for Breakthrough Medicines
  • Ensure compliance with The Center for Breakthrough Medicines values and policies
  • Evaluate risks and opportunities with Sr. 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.
  • Continuously reach out to academia, conferences, literature to stay ahead of developments in the space of Cell and Gene Therapy
  • Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.
  • Where required, and in partnership with QA/Regulatory Affairs, meet with relevant Regulatory Bodies to resolve any compliance issues or help with any new business requirements that potentially impact the accreditation or compliance status.
  • 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 10+ years of experience in Flow Cytometry / Cell Biology laboratory experience or M.S. degree in Flow Cytometry or related field with 15+ years of relevant experience is preferred
  • Strong background and deep subject-matter expertise in virus biology and Cell biolgy.
  • Experience managing a large team of full-time scientists, including PhD level scientists, supporting multiple projects, and fostering a culture of innovation, teamwork, performance and trust, with 5 years (minimally) of People Management experience is required.
  • 10 years of biotechnology experience or relative industry experience is required, with experience in Gene Therapy preferred.
  • Demonstrated Experience transferring, qualifying and validating to a GMP lab setting (cGMP experience is required).
  • 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

Education & Experience

  • Ph.D. in relevant field with 10+ years of experience in Flow Cytometry / Cell Biology laboratory experience or M.S. degree in Flow Cytometry or related field with 15+ years of relevant experience is preferred
  • Strong background and deep subject-matter expertise in virus biology/Cell biology
  • Experience managing a large team of full-time scientists, including PhD level scientists, supporting multiple projects and fostering a culture of innovation, teamwork, performance and trust, with 5 years (minimally) of People Management experience is required.
  • 10 years of biotechnology experience or relative industry experience is required, with experience in Gene Therapy preferred.
  • Demonstrated Experience transferring, qualifying and validating to a GMP lab setting (cGMP experience is required).
  • 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

July 29, 2022

Research Associate – TEMP

Summary

The Research Associate will execute testing with regards to the analytical method development for cell and gene therapy products with a multidisciplinary R&D team focused on developing innovative assays for cell and gene therapy products.

Responsibilities

  • Execution of testing in an R&D & GMP laboratory
  • Collaborate with a diverse team to develop new assays for cell and gene therapy applications.
  • Conduct cell-based, molecular and analytical assays
  • With supervision design, execute and interpret experiments to meet R&D 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.
  • Work with scientists to transition assays to GMP
  • Generate, analyze, and record high-quality data using documentation, and database tools.
  • Maintain laboratory records and contribute to laboratory organization and maintenance.
  • Independently develop, optimize, and qualify analytical methods to characterize viral vector and cell therapy products.
  • Perform and coordinate analytical testing in support of process development, cGMP investigations and product characterization.
  • Designs and executes experiments to characterize RCT drug product for protein expression, cell metabolism and lipid structure and function.
  • Identifies critical product quality attributes in RCT drug product through forced degradation and structure-function related studies.
  • Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams.
  • Evaluate new technologies to assess biophysical and biochemical properties of RCTs.
  • Participate in the support of analytical activities related to analytics including method qualification, data trending, troubleshooting, optimization, review and reporting.
  • Reviews, interprets 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.

Education & Experience

  • Bachelor’s Degree in Biology, Biochemistry, Molecular Biology, Immunology or related discipline
  • Minimum 3 years’ experience in cell and molecular biology, biochemistry, chemical engineering, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
  • 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.
  • Capability and desire to work in a dynamic, fast-paced, innovative environment
  • Prior experience with cell culture, ELISA and flow cytometry techniques is highly desirable
  • Prior exposure to GMP, ISO regulated environment is a desirable
  • Independently troubleshoot experiments and contribute to research directions
  • Understanding of compliance and cGMP considerations.

July 28, 2022

Technical Writer-TEMP

Summary

· Support execution of New Product Programs and Continuous Improvement projects within the Viral Vector platform at the Center for Breakthrough Medicine.

· Supporting all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make CBM a best in class CDMO facility.

· Candidate must be prepared for an exciting, dynamic, and fast paced CDMO/start up environment.

Responsibilities

· Development and revision of Master Batch Records, Work Instructions, Logbooks, Forms and Standard Operating Procedures to support Vector Manufacturing.

· Authoring and creating documents associated with New Products Programs and Continuous Improvement Projects and deliverables for VV.

· Authoring and creating documents associated with the initial stand up of the organization.

· Maintain a culture of Safety, Quality, Delivery, and Operational Performance based on CBM Goals and Vision.

· Maintain Cost Mindfulness and promote Innovation and Team work to meet or exceed Revenue and EBITDA targets.

· Focus on Client Success and Transparency with each program.

· Communicate effectively and timely to address internal and client comments ensuring the document content meets the intention and required details to be successful.

· Participate as a key member of Program Project Teams to complete deliverables On Time in Full.

· Escalate issues that would jeopardize the Program Timeline and milestones.

· Work Cross-functionally on project team and work closely with the shop floor to ensure documents are meaningful.

· Development of Batch Records, SOPs, Training Modules for tech transfer projects and internal vector CAPAs, deviations, and continuous improvement objectives.

· Work closely with process SMEs to execute on Time Technical Transfer of new or optimized programs by ensuring documents are completed and correct.

· Support Quality Audits, Supplier Audits, and Regulatory Inspections.

· Follow Operational Excellence Standards with department

· Manage and track assigned documents through the entire life cycle (i.e. creation, review, revision, approval) using detailed project planning to meet project milestones.

Qualifications

·The ideal candidate is preferred to have a Bachelors Degree in a technical or applicable discipline or equivalent.

·The Ideal candidate is preferred to have 2+ years experience or equivalent.

·Regulatory experience with FDA, EU commercial and Clinical is a plus.

·Knowledge of quality systems or document control systems a plus.

·Strong Cross Functional Communication skills.

·Technical Skills and Experience preferred for the role:

·Technical Transfers

·Project Planning

·Document Creation

·Quality document creation and management

·Problem Solving

June 8, 2022

Associate Principal Scientist, AD – Flow Cytometry

Summary

The Associate Principal Scientist will work with cross functional teams and assist with analytical method development, validation, release and stability specification assays, and additional assays needed to support cell and gene therapy client programs for The Discovery Labs. This role requires someone with good knowledge of analytical development and scientific understanding of cell therapy products.

Responsibilities

·Assist with technical and laboratory activities focused on method development, qualification and analytical strategy for multiple cell and gene therapy programs.

·Advance scientific understanding of cell therapy products.

·Assist with the application of state-of-the-art cellular analytics research techniques that aim to deepen product understanding in order to improve methods with respect to efficient and rapid method transfer/qualification execution.

·Provide scientific and technical assistance for analytical ultracentrifugation, molecular, virology and cellular analytical capabilities.

·Support CMC and product development teams to ensure robust data analysis, solid GMP method implementation, and broad incorporation of analytical strategy within CMC functions.

·Monitors project plans and resources to ensure alignment with overall research goals and objectives.

·Participate in and assist with various aspects of method development, transfer, characterization, investigation and assay validation while collaborating with Cell Therapy Technology, Testing, Process Development, Clinical and Commercial Manufacturing, and Quality teams.

·Provide scientific assistance with development operations, and clinical and commercial QC teams.

·Maintain current awareness of GMP/GTP and other regulations, industry standards and trends that are applicable to current and future Cell and Gene Therapy Development operations and products.

·Responsible for some administrative duties for the group.

·Independently applies scientific and/or cross-functional knowledge to achieve project goals.

·Implements strategic departmental research and development goals or ideas.

·Accountable for accomplishing project goals and objectives; anticipates and prioritizes workflow to achieve desired outcomes.

·Assist in implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards.

·Application of advanced scientific knowledge associated with larger and more complex experiments and projects.

·Defining and implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards.

Qualifications

·PhD plus 6-7 years of experience or MS in a relevant discipline (cell biology, Immunology, molecular Biology) with minimum of 16 years of relevant R&D/analytical development experience.

·Previous industry or academic experience in cell and gene therapy, AAV research and development is preferred.

·Established track record of success supporting early and late stage CMC and clinical product development teams. Cell therapy product characterization, method bridging, comparability, control strategy experience is a plus.

·Technical experience in analytical ultra-centrifugation, molecular biology, virology and/or cell-based potency methodologies

·Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management.

·Strategic thinker with excellent problem solving and conflict resolution skills.

·Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.

·Strong troubleshooting and communication skills, highly organized with strong record keeping and an ability to multi-task.

·Highly collaborative working style and ability to adapt in a fast paced, rapidly developing environment.

June 6, 2022

Research Associate Flow Cytometry

Summary

The Research Associate will support the development and troubleshooting of various projects related to cell and gene therapy products. This role presents unique opportunity to grow diverse technical and intellectual skills in a highly dynamic and impactful environment. We are looking for an individual who is highly motivated by our mission and technology, is self-organized, and is flexible to support a range of projects within a fast-growing organization, must be independent, goal oriented, and able to efficiently work across multiple projects.

Responsibilities

  • Collaborate with a diverse team to develop new products for cell and gene therapy applications.
  • Perform microbial testing of raw materials, bulk, finished products and aseptic packaging components.
  • Endotoxin and Sterility testing.
  • Write and update SOP’s.
  • Perform Bioburden, pH, TOC, Conductivity, Osmolality.
  • Plate enumeration.
  • Perform Growth promotion of media.
  • Aseptic Sampling of in-process samples for testing.
  • With supervision design, execute and interpret experiments to meet department objectives.
  • Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices. and standard operating procedures.
  • Maintains laboratory supplies and reagents inventory.
  • Compiles, analyzes, trends data and creates visual representations of data.
  • Generate, analyze, and record high-quality data using documentation, and database tools.
  • Maintain laboratory records and contribute to laboratory organization and maintenance.
  • Perform and coordinate microbial testing in support of process development, cGMP investigations and product characterization.
  • Reviews, interprets, 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, Molecular Biology, Immunology, or related discipline
  • Minimum 1-3 years’ experience in pharmaceutical, Microbiology, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
  • 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.
  • Capability and desire to work in a dynamic, fast-paced, innovative environment
  • Prior experience with working in a GMP lab is highly desirable.
  • Prior experience with Environmental monitoring in aseptic areas is required.
  • Prior exposure to GMP, ISO regulated environment is a desirable.
  • Independently troubleshoot experiments and contribute to research directions.
  • Understanding of compliance and cGMP considerations.

May 27, 2022

Senior Scientist Flow Cytometry

Summary

The Discovery Labs Center for Breakthrough Medicine is seeking a solid candidate to join our flow cytometry team as a technical lead at Analytical Development and Testing organization.

Responsibilities

  • Demonstrate the highest moral standard and ethical integrity.
  • Optimize and qualify assays for characterization and analytical testing of cell therapy products.
  • Capable of making decisions independently and troubleshoot/optimize experiments and procedures.
  • Flexible to support multiple research projects as the AD organization grows.
  • Author and review test method SOPs, method development reports, qualification protocols, risk assessments, and transfers methods to partner functions, and represent the Analytical Flow Cytometry team in cross-functional meetings.
  • Able to perform GMP operations, including following detailed SOPs, maintaining training, and following good documentation practices.
  • Responsible for operation and maintenance of flow cytometers.

Qualifications

  • Ph.D. with 1+ years of directly flow cytometry experience OR MS with 5+ years of directly related experience
  • Basic knowledge of immunology preferable adaptive immunity
  • Experience in multicolor flow cytometry and mammalian cell culture is required
  • Experience with multiple flow cytometry data analysis tools is required
  • Prior experience with cell proliferation, cytokine release, or potency assay development is desirable
  • Demonstrate ability to maintain lab execution records and perform data analysis.
  • Strong technical writing and presentation skills
  • Experience in cell therapy and GMP environment is strongly desirable

May 13, 2022

Senior Manager/Associate Director – Sterility/Compendial testing

Summary

Center for Breakthrough Medicines is seeking a Senior Manager/Associate Director – Sterility/Compendial testing to join its Microbiology Department. The primary responsibility of the role is to ensure compliance to GxP from the perspective of Quality Control (Microbiological Testing Mycoplasma detection, Raw Material consumable, excipient, API testing and release and Stability). This position proactively drives change and improvement to the QC microbiology lab, while establishing a culture of compliance through implementation of harmonized standards, testing, monitoring, and reporting.

Responsibilities

  • Maintain the QC Microbiology Lab and function in full cGMP-compliance and continue to challenge the status quo of the labs to enhance throughput efficiency and Compliance while ensuring Method lifecycle management.
  • Responsible for installation of laboratory equipment and qualification/validation of lab equipment for intended use in QC laboratory to support testing (e.g., Mycoplasma detection, Bioburden, Endotoxin, Sterility Testing, CCIT and Sub Visible particulate)
  • Ensure proper oversight and management for protocol development, report writing, trend report and deviation management
  • Ensure that priorities (lab scheduling, logistics and flow of activities) for testing and review are set and followed
  • Ensure proper scheduling and prioritization of workload and staff to ensure all activities are performed.
  • Lead laboratory investigations and facilitates root cause analysis
  • Reviews documents to ensure completeness, accuracy, consistency, and clarity and ensure that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs
  • Ensure programs for trending are in place including assessment for CAPAs based on trend conclusions
  • Collaborate with Manufacturing, Supply Chain and Logistics and Quality to ensure an
  • uninterrupted supply of materials for use in Manufacturing
  • Participate in audits (internal / external) where necessary (prep, support, interactions) internal/external audit program
  • Participate in the preparation and consolidation of the budget of the Quality Unit
  • Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes
  • Collaborate significantly with cross functional groups, including QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs

Functional Responsibilities:

  • Manage a team of Microbiologists in the Quality Control department
  • Oversees the microbiological testing for raw materials, in-process materials, intermediates, and final product
  • Oversees the environmental monitoring of the clean rooms (under ISO and EU specifications)
  • Read, trend, and report in-process, raw material, finish product and water bioburden testing results
  • Oversee Lab Investigations
  • Implement new or Rapid technology to increase efficiency

Key Performance Indicators:

  • Delivery of results in time and quality (e.g., review and approve validation, qualification protocols and reports)
  • Complete and ensure projects are progressing according to plan and quality expectations.
  • Ensure there is a limited number of gaps identified during external and internal audits and in the same context, none of the issues identified are severe / critical
  • No critical observations during authority inspections
  • No delay with new product introductions caused by the lab
  • Support implementation of programs such as but not limited to Labware.
  • Ensure programs are in place for trending which includes determination of alert and action limits and systems in place to act accordingly

Qualifications

  • Education: BS in microbiology or closely related field with 7 years’ experience in a microbiology lad, preferably in the pharmaceutical or biotech industry; with 3-5 years of that experience in a leadership role in the microbiology lab
  • Ability to maintain integrity and honesty, and always communicate with transparency
  • Continuously drive to improve process for improved performance
  • Ability to lead and be accountable for team’s performance and results
  • Manage internal and external relationships
  • Develop strategy and create metrics to measure effectiveness of strategy
  • Provide leadership to direct and indirect reports
  • Coaching and conflict resolution
  • Handle incidents appropriately and with a sense of urgency
  • Ability to problem solve and identify root cause
  • Ability to communicate at all levels and across all functions
  • Ability to build, lead and motivate team
January 22, 2022