The CMC Team Leader at Biologics Consulting will serve as the coordinator and peer leader for senior consultants with expertise in Manufacturing and Regulatory Science, Analytics and Quality (cGXPs). Moreover, the CMC Team Leader is a Subject Matter Expert (SME) who is a leadership resource for team members, providing mentoring, knowledge, experience, motivation, and business development support. CMC Team Leader takes direction from Sr. Management and assumes primary responsibility to achieve Corporate goals and objectives and provides insight to Sr Management on trends/practices developing within the industry.
The Team Leader is also responsible for knowing Corporate policies and procedures and is responsible for sharing their subject matter expertise and recommendations on how to improve quality and efficiency within their Team and the organization. Team Leader will encourage team effort and supportive attitudes between team members and across other Specialty Teams. The Team leader will also have primary responsibility for providing consulting services in his/her area of expertise.
This position requires approximately 50% consulting, 25% business development, and 25% coordination and oversight. Team Leaders are required to attend two 1-hour meetings per month (biweekly) with the Biologics Senior Leadership Team (SLT) and/or Sr. Management. Additionally, Team Leaders are required to convene regular meetings with their Specialty Team and provide a report to Sr. Management on a quarterly basis summarizing metrics, progress in the areas of responsibility, most notably: consulting activity, business development and overall Team performance.
Duties and Responsibilities: To include the following and other duties identified and assigned.
Qualifications: This position requires a graduate degree (or equivalent) in a scientific or clinical discipline of practice; a minimum of 10 years regulated product experience within FDA or industry, recognition as an expert in the field of expertise, and a minimum of 5 years’ experience in consulting.
Skills: Proficient in Microsoft Office Suite, keyboard skills, superior oral and written communications skills, strong documentation skills, math aptitude, diplomacy and leadership skills, professionalism, time management, ability to multi-task, able to work unsupervised, able to maintain confidentiality
The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.