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Senior Director, Process Development Lead

2 months ago


Reston, Virginia, United States Fraser Dove International Full time

Senior Director, Process Development Lead

Transformative Leadership Opportunity in Advanced Technology

About Us

Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. We take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.

Job Summary

We are seeking a seasoned leader to spearhead our client's Process Development function. As a key member of the leadership team, you will be responsible for driving innovation, improving processes, and ensuring the successful delivery of client and company projects.

Key Responsibilities

  • Strategic Leadership
    • Develop and implement process development strategies to drive business growth and improve operational efficiency.
    • Collaborate with cross-functional teams to identify and prioritize process improvement initiatives.
  • Process Development and Implementation
    • Oversee the development and implementation of process development plans, including project ideation, bid defense, assignment, progression, and completion.
    • Lead the implementation of company systems, including ELN, ERP, Chem Inventory, and training.
  • Operational Management
    • Oversee the operations of the bioconjugation department, including resource planning and project delivery.
    • Manage technical input to GMP Batch Records and other Quality documents according to ICH and FDA guidelines.
  • Collaboration and Communication
    • Collaborate with QA/AMD/QC and Management to develop tox and GLP batches.
    • Communicate effectively with supervisors, colleagues, and subordinates to ensure seamless project execution.
  • Leadership and Development
    • Mentor group leaders for team building and career advancement.
    • Provide key leadership in the advancement of science and technology for the industry and business.
  • Continuous Improvement
    • Evaluate lab practices for continuous improvement.
    • Provide assistance in laboratory design and process capabilities.

Requirements

  • Proven Track Record
    • Proven track record of drug discovery, development, and manufacture with extensive CMC and GLP/GMP knowledge and experiences.
  • Leadership and Communication Skills
    • Excellent oral, written, and interpersonal skills in scientific and business communications and presentations.
  • Problem-Solving and Analytical Skills
    • Possess excellent problem-solving skills and demonstrate a thorough understanding of protein chemistry, protein handling, purification, and characterization.
  • Independence and Prioritization
    • Ability to independently prioritize work assignments and consistently demonstrate the ability to perform assigned tasks through rigorous data collection and applying analytical tests and instrumentation in the laboratory.

What We Offer

Fraser Dove International is committed to providing a dynamic and supportive work environment that fosters growth and development. As a key member of our team, you will have the opportunity to work with exceptional life science organisations and contribute to the development of life-changing drugs, treatments, and devices.