Job Responsibilities:
Lead, mentor, and manage a group of scientists to support early CMC development for customers.
Define and optimize the work processes within the department, and coordinate cross-functional project teams to ensure the development services meet customers’ quality requirements and timelines.
Participate in decision-making process with senior management on budgeting and planning, and implementation.
Initiate, develop, and foster a long-term partnership with customers.
Manage the daily operations and activities within the department. Provide training and technical guidance to scientists to ensure the quality of work and timely completion of projects as required.
Manage a group of scientists to support physical characterizations of APIs for their develop ability assessment, and oral dosage form development.
Qualifications:
Hands-on experience and in-depth knowledge are essential on thermal analysis, salt and polymorph screening, solubility, hygroscopicity, stress study, excipient compatibility, and overall solid state characterizations using TGA, DSC, microscopy, XRD, and particle size measurement.
Education in pharmaceutical sciences, physical chemistry, or analytical chemistry. Have a degree of Ph.D. with 5 – 10 years, or M.S. with 15+ years of technical and managerial experience in pharmaceutical industry.
Be responsible for departmental performance and individual performance evaluations.
Be familiar with overall pharmaceutical development process, cGMP and regulatory guidelines.
Create, review, approve, and implement SOPs within the department.
Maintain a safe and compliant work environment.
Have excellent communication and interpersonal skills.