Director, Analytical Development Job Description Template
Our company is looking for a Director, Analytical Development to join our team.
Responsibilities:
- Identify and build productive relationships with strategic external partners;
- Prepare and edit CMC sections and provide input into Regulatory submissions and approvals;
- Position includes need to travel (10%) in support of job responsibilities;
- Ensure the highest possible technical standards are understood and utilized for the development of the appropriate analytical methods;
- Identify and implement state-of-the-art manufacturing analytical techniques for use in clinical and commercial manufacturing;
- Develop annual budgets and assist the executive staff and financial organization in developing strategic plans; adjust priorities as required;
- Provide scientific guidance and oversight while factoring in regulatory, technical, and intellectual property considerations;
- Publish and secure intellectual property for any new process or analytical techniques developed by the department;
- Attendance is mandatory;
- Experience prolonged sitting, standing, walking, bending, stooping and stretching.
Requirements:
- Lift up to 15 lbs;
- PhD in biochemistry, immunology, cell biology, or other related field;
- Strong verbal communication skills;
- In-depth understanding of CMC requirements for regulatory submissions;
- 5+ years of experience developing processes for cellular therapies or complex biologics;
- Sit for extended period of time in front of computer;
- Proven success leading teams;
- Cell therapy / TIL experience a plus;
- 5+ years of senior management level experience within the Biotech or Pharma industries.