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Analytical Technical Program Leader, Testing & Analytical Services

King of Prussia, PA, US
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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

Analytical Technical Program Leader, Testing & Analytical Services

King of Prussia, PA, US
Apply Now >