866-274-4009 Contact Us

Research Associate, ELISA

October 18, 2022

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

Qualifications

  • 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.
  • Minimum 3 year’s of experience with ELISA and similar techniques
  • 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.

Contact Us Now

Associate Scientist/Scientist –Analytical Development-Molecular Analytics

October 14, 2022

Summary

The Scientist will support the development, validation, and transfer of molecular biology methods in support of cell and gene therapy product development and analytical testing. The incumbent will serve as a subject matter expert in the analysis of virus products using standard and advanced molecular techniques. This role presents a unique opportunity within the Testing and Analytical Services 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 analytical method develop, optimization, qualification, and transfer of analytical methods in support of adeno-associated virus and lentivirus in-process, drug substance, and drug product characterization and product release.
  • Maintain analytical instrumentation and contribute to the organization of reagent stocks, cell banks, and instrument documentation.
  • Design, execute and interpret experiments to meet R&D objectives.
  • Develop presentations and effectively communicate technical results to internal technical groups.
  • Maintain an up-to-date lab notebook and relevant documentation.
  • 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, chemistry, or related discipline with >8 years of relevant industry experience, or a master’s degree with a minimum of 3 years industry experience.
  • Prior experience with ddPCR, dPCR, qPCR, gel electrophoresis, restriction enzyme digestion, DNA/RNA quantification, gene expression analysis, and other molecular biology techniques is required.
  • Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a GxP laboratory environment preferred.
  • Experience developing and qualifying analytical methods for virus products required.
  • Cell and gene therapy experience 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.

Contact Us Now

Director of Molecular Biology, Cell and Gene Therapy Operations

Summary

The Director of Molecular will be responsible for providing senior leadership over Molecular testing services supporting Cell and Gene Therapy Programs at the Center for Breakthrough Medicines (CBM). The Director will be a key member of the Testing Leadership team and will be responsible for leading the development of a new Molecular laboratory, transitioning and implementing GMP test methods from Analytical Development and other cross-functional groups, and CBM’s clients. The Director will be responsible for managing a large team of Cell and Gene Therapy scientists that will be directly responsible for delivering 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 and new modalities
  • Lead development of a new Molecular laboratory at CBM for cell and gene therapy programs that will be supporting GMP work.
  • Provides technical and scientific leadership to the team responsible for validation and GMP Testing of Molecular assays supporting Cell and Gene Therapy Programs
  • Responsible for managing a total of 30 – 40 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.
  • Maintain Operational execution of the department to CBM expectations through regular business reviews and other performance management activities.
  • 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 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.
  • Perform all other related duties as assigned by the Head of Testing Operations.

Qualifications

  • Ph.D. in relevant field with 10+ years of experience in molecular laboratory experience or M.S. degree in Molecular or related field with 15+ years of relevant experience is preferred
  • Strong background and deep subject-matter expertise in Molecular 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

Contact Us Now

Scientist – Analytical Development-Chromatography and Separations Sciences

October 12, 2022

Summary

The Scientist will support the development, validation, and transfer of chromatography and separations sciences methods in support of cell and gene therapy product development and analytical testing. The incumbent will serve as a subject matter expert in the analysis of virus products using standard and advanced chromatography techniques. This role presents a unique opportunity within the Testing and Analytical Services 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 analytical method develop, optimization, qualification, and transfer of analytical methods in support of adeno-associated virus and lentivirus in-process, drug substance, and drug product characterization and product release.
  • Maintain analytical instrumentation and contribute to the organization of reagent stocks, cell banks, and instrument documentation.
  • Design, execute and interpret experiments to meet R&D objectives.
  • Develop presentations and effectively communicate technical results to internal technical groups.
  • Maintain an up-to-date lab notebook and relevant documentation
  • 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, chemistry, or related discipline with >8 years of relevant industry experience, or a master’s degree with a minimum of 3 years industry experience.
  • Prior experience CE-SDS, SDS-PAGE, SEC MALS, HPLC, DLS, AUC, UV spectrophotometry, and other chromatography and separations techniques is required.
  • In addition, experience with ELISA techniques preferred.
  • Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a GxP laboratory environment preferred.
  • Experience developing and qualifying analytical methods for virus products required.
  • Cell and gene therapy experience 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.

Travel <10%

Contact Us Now

Scientist/Sr. Scientist – Bioassay Analytical Development

October 7, 2022

Summary

The Scientist will support the development, validation, transfer of cell-based, potency analytical methods in support of cell and gene therapy product development and analytical testing. This role presents a unique opportunity within the Testing and Analytical Services 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 bioassay method development to evaluate the functionality and potency of cell and gene therapy products.

· Under minimum supervision develop, optimize, and qualify analytical methods to characterize cell therapy products.

· Maintain analytical instrumentation and contribute to the organization of reagent stocks, cell banks, and instrument documentation.

· Design, execute and interpret experiments to meet R&D 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, or a Master’s degree with a minimum of 3 years industry experience preferred.
  • Minimum 1 year experience in working to develop analytical methods used for process characterization or release testing in a GxP laboratory environment preferred.
  • Experience developing and qualifying potency methods required.
  • Cell and gene therapy experience preferred.
  • Prior experience with human cell isolation, aseptic technique, cell culture and banking, ELISA/MSD/ELISpot, or flow cytometry is 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.

Contact Us Now

Senior Scientist Flow Cytometry

September 26, 2022

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
Contact Us Now

Sr. Scientist, Mass Spectrometry

September 20, 2022

Summary

Your responsibilities as a Senior Scientist on the Mass Spectrometry Analytical development team include developing and routine testing mass spectrometry assays, to support the Cell Therapy program.

The successful candidate needs to have a solid understanding of Cell and Gene Therapy Production, as well as high-throughput and automated analytical assay development skills. The candidate will responsible for Assay development, qualification, implementation, and transfer to quality control, both manually and automated using LC/CE and LC-MS.

Responsibilities

· This is a lab-based/hands-on role where you will join a diverse team at the Center for Breakthrough Medicines (CBM) to support the Cell and Gene Therapy Programs

· The Senior Scientist will be responsible for executing and developing analytical strategies in support of the Analytical testing platform at CBM Gene and cell therapy programs.

· Routine analytical testing for separation (LC, CE, and LC-MS) based assay for in-process, stability, characterization, release assays, purity, strength, potency, drug substance, and drug product samples.

· Developing analytical testing using (LC, CE, and LC-MS) based assays to support in-process sampling, drug substance, and drug product samples as well as stability, characterization, release, and purity.

· Extensive experience and understanding of mass spectrometric various techniques in implementing LC-MS methods using Orbitrap, and TOF for intact mass analysis, peptide mapping, and post-translational modification

· Capable of developing and implementing absolute quantification LC-MS/MS methods for different biological matrices as well as quantitative LC-MS/MS methods (LOD, LOQ, confidence intervals, etc.)

· Strong hands-on UPLC and high-resolution mass spectrometry, troubleshooting, and maintenance

· Cross-functional collaboration with Vector- and Cell-Analytical Development & Translational teams for method transfer, translating manual or low throughput separation-based assay (LC, CE, and LC-MS) into the HTP (High-throughput) or automated methods.

· Collaborating cross-functionally with Vector- and Cell-Analytical Development & Translational teams for method transfer from manual or low-throughput assays (LC, CE, and LC-MS) into the HTP (High-throughput) or automated methods.

· Demonstrated ability to bring innovations and creativity to the analytical testing and team player.

Qualifications

· Ph.D. in Analytical chemistry, biochemistry, or related field with 5 – 7 years of experience in analytical assay development in CGT in the biotech/biopharmaceutical industry.

· Hands-on experience in setting up top-down and bottom-up, peptide mapping mass spectrometry analyses of biotherapeutics, beside

· Developing analytical methods in compliance with ICH guidelines.

· Must be able to work in a fast-paced environment

· Extensive experience in developing LC-MS, CE-MS, and LC-MS-based assays to test the quality of AAV vectors or other viral vectors used for gene therapy

· Hands-on experience in separation-based technologies and platforms LC-MS (Thermo, Waters, Bruker) including nano-flow &HRMS

· In-depth understanding of various Mass spectrometry quantification technologies

· Experience with robotic liquid handlers (for automated sample preparation.

· Experience designing a proof of concept studies using literature.

· Experience writing technical documents including technical reports, and qualification protocols and reports.

· Outstanding communication and presentation skills with the ability to work well as part of a multidisciplinary team; detail-oriented, multitasking, goal-oriented, timeline-oriented, and critical thinker.

· Maintain excellently written documentation of completed experiments (ELN, LIMS) and maintain knowledge share systems (MS-Teams and Share Points).

Contact Us Now

Microbiologist II

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.
  • Understanding of compliance and cGMP considerations.
Contact Us Now

Principal Scientist, Analytical Development

August 22, 2022

Summary

The 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 Center for Breakthrough Medicines. 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 experience in allogenic and/or autologous cell therapy CMC or product development experience 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.

Contact Us Now