866-274-4009 Contact Us

Technical Program Leader – Process Development

King of Prussia, PA, US
Apply Now >

Summary

The Center for Breakthrough Medicines is looking for a Technical Program Leader, Process Development to lead complex scientific efforts and add significant value to the organization. The Technical Program Leader has responsibility for the overall technical program in the Nucleic Acid, Viral Vector, and Cell Therapy asset pipeline, and driving these to successful outcomes. This includes serving as the primary technical leader for client programs, leading successful Life Cycle strategies for development and commercial phases (including comparability), 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 leader for the delivery of key product/process development and technical operations deliverables.

Responsibilities

  • Develop, manage, and sustain strong relationships with current and future customer accounts and represent CBM as the technical program leader
  • Contribute to a high-performing team of PhD & non-PhD, staff, capable of delivering robust, high-quality processes to enable the GMP manufacture of advanced therapies and delivery to those patients in need
  • Manage team of technical professionals. Hires and develops employees within the department in support of site and client objectives. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions
  • 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 process development, tech transfer, technical operations, and regulatory filings
  • 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 Teams and drive a culture of continuous improvement
  • Own and execute Quality by Design (QbD) for programs
  • 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
  • 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 biochemical engineering or biological sciences with 10+ years of experience required

Technical Program Leader – Process Development

King of Prussia, PA, US
Apply Now >