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Analytical Technical Program Leader, Testing & Analytical Services

December 2, 2022

Summary

The Center for Breakthrough Medicines is looking for Analytical Technical Program Leaders to lead our highly innovative team and add significant value to the organization. The Technical Program Leader has responsibility for the overall analytical technical programs in the Nucleic Acid, Viral Vector, and Cell Therapy asset pipeline for Testing and Analytical Development, and driving these to successful outcomes. This includes leading a cross-functional team serving as the primary technical leaders for client programs, leading successful analytical development technical transfers, and working cross-functionally with technical and operations teams to deliver technical programs. The leader will be accountable for the successful execution of the corresponding strategies in compliance with Regulatory Agency and Industry Guidance. During the clinical/commercial manufacturing preparation phase, this role will serve as a senior leader for the delivery of key product and technical operations deliverables.

Responsibilities

  • Establish and lead Technical Programs within Testing & Analytical Services at The Center for Breakthrough Medicines
  • Develop, manage, and sustain strong relationships with current and future customer accounts and represent CBM as the analytical technical program leader
  • Establish core teams capable of delivering robust, high-quality processes to enable the GMP testing of advanced therapies and delivery to those patients in need
  • Lead technical professionals in support of site and client objectives.
  • Establish and adhere to departmental/CBM objectives, quality, safety, and compliance standards, budgets, laboratory schedules, and program deliverables
  • Serve as lead, senior subject matter expert in advanced therapy Product and Processes, at all stages of development including analytical development, tech transfer, technical operations, GMP Testing Operations, and regulatory filings
  • Serve as Senior Leadership Team member within the analytical organization, responsible for contributing to organizational stand-up and functioning, facility readiness and maintenance, program delivery, budget setting and adherence, serving on various governance bodies, and establishing/supporting high-performing culture
  • Oversee process transfers to and from internal and external business partners
  • Support the business development function in the assessment of new opportunities and provide technical input to prospective customers, including the demonstration of capability at customer visits
  • Make decisions, based on the professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices
  • Proactively develop and sustain strong relationships with internal stakeholders in manufacturing, process development, project management, quality, etc., to promote successful customer management
  • Evaluate the functional strengths and developmental areas in the Technical Program Leaders team and drive a culture of continuous improvement
  • Own and execute Quality by Design (QbD) for programs and Analytical Control strategies
  • Provide key input into the development of manufacturing platforms and novel technologies

Qualifications

  • Solid foundation in the fundamentals of advanced therapy process and product development
  • Strong background and deep subject-matter expertise in Cell and Gene Therapy and Analytical Development
  • Working knowledge of cGMPs related to the production of microbial therapeutics
  • Process development and scale-up experience with demonstrated success in meeting process goals, tech transfer, GMP technical operations, and regulatory approvals (IND and BLA)
  • Experience in Nucleic Acid, Viral Vector, and Cell Therapy Processes including product development, cell culture, vector production, purification, and drug product processes
  • Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects
  • Rational persuasion particularly in the discussions with customers
  • Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects
  • Ability to interpret and manipulate data, define problems, establish facts, draw valid conclusions, and make decisions
  • Ability to deal with abstract and concrete variables in situations where only limited standardization exists
  • Extremely high level of initiative, agility, tenacity, and emotional intelligence
  • Excellent oral and written communication skills

Education & Experience

  • B.S./M.S./Ph.D. in biological sciences with 10+ years of experience required

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Associate Scientist, Virology

October 27, 2022

Summary

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

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

The Scientist will be responsible for assisting in performing and managing analytical method development, validation, release, and additional assays needed to support cell and gene therapy client programs. The candidate will assist in advancing strategic and scientific direction for the department to establish analytical development, analytical method lifecycle management strategies, and implement novel technologies.

Responsibilities

  • Consistently demonstrate and model the highest levels of moral standards and ethical integrity
  • Capture data accurately and timely, and maintain detailed records in compliance with applicable regulatory, safety, and environmental standards
  • Demonstrate ability to follow documented procedures
  • Perform, coordinate and assist in testing to support analytical development, process development.
  • Provide flexible support to multiple and varied research projects

· Consistently demonstrate high expectational organizational skills

· Demonstrate ability to learn quickly and to work under minimal supervision

· Demonstrate strong attention to detail and ability to multi-task

· Assist in general laboratory and equipment maintenance

· Assist in supplies and materials ordering and inventory

Qualifications

  • BS Degree Required preferred

· Cell Biology/cryopreservation/cell banking experience preferred but not required

· Virology (classic Virology and/or molecular virology) experience preferred but not required

  • Experience in gene therapy and GMP environment is strongly preferred but not required

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Senior Microbiologist

August 19, 2022

Summary

The Senior Microbiologist 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.

• Serve as back up for microbial testing of raw materials, bulk, finished products and aseptic packaging components.

• Serve as back up for Endotoxin and Sterility testing and method suitability development.

• Write and update SOP’s.

• Back up for performing Bioburden, pH, TOC, Conductivity, Osmolality.

• Mycoplasma testing

• Microbial identification

• SME and Technical lead for client interactions

• Oversees Growth promotion of media.

• 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.

• Perform and coordinate microbial testing in support of process development.

• Perform Lab investigations.

• Author reports and source documentation to support regulatory filings

Other duties assigned per business needs.

Qualifications

• Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal.

• Capability and desire to work in a dynamic, fast-paced, innovative environment

• Prior experience with working in a GMP lab is highly desirable.

• Prior expertise in Sterility and Compendial testing is preferred.

Understanding of compliance and cGMP considerations.

Education & Experience

• Bachelor’s Degree in Biology, Biochemistry, Molecular Biology, Immunology, or related discipline

• Minimum 4 -5 years’ experience in pharmaceutical, Microbiology, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.

• Minimum 1 year of experience in supervisory role.

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Senior Manager – Microbiology Testing

January 22, 2022

Summary

Center for Breakthrough Medicines is seeking a Senior Manager – Microbiology 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 and Environmental Monitoring, 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 in these areas
  • 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)
  • 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 in a timely manner
  • 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 Utilities.
  • 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 environmental, personnel, in-process, raw material, finish product and water bioburden testing results
  • Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests)
  • Prepare and send out samples for microbiological identification
  • Maintain historical files on organisms found in classified areas, microbial identification and trending
  • Inspection of media fills operations
  • Initiate OOS/OOT or Environmental Monitoring Excursion Investigations
  • Implement new or Rapid technology to increase efficiency

Qualifications

  • Education: BS in microbiology or closely related field with 7 years’ experience in a microbiology lab, 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
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