The U.S. Pharmacopeial Convention (USP) Director, Compendial Development Laboratory in Hyderabad, India
Director, Compendial Development Laboratory
The Director, Compendial Development Laboratory, is a supervisory management position in the Research and Development Department of USP India. The incumbent leads a team of Managers and guides them in method development and validation work as a part of the Compendial development projects ensuring alignment with the different program units and organization goals. The Director is also responsible for maintaining GLP and safety environment in the lab. The Director supervises the performance, training and development of the staff and Interacts with other USP departments and sites. The Director works closely with the Scientific Liaisons across the organization to exchange information, solicit input, and advance the work.
Roles and Responsibilities
Provides guidance to scientists working in the area of method development and validation in accordance with the CDL Manual;
Establishes appropriate processes and systems to effectively improve operating productivity and manages continuous improvement programs for all program units;
Develops new and/or revises existing processes to facilitate method development and validation for new program units;
Supports Senior Director – R&D to plan annual budget according to deliverables and overall business priorities;
Participates in USP’s User forums, training Courses, external scientific conferences/ workshops as a speaker and becomes an advocate for USP Standards
Collaborates with pharmaceutical/ excipient/ food industries, instrument vendors and regulatory bodies within India to build and establish stakeholder relationships to support monograph development and modernization process;
Develops and directs senior staff by active coaching and training while cultivating collaborative team culture, creative problem-solving and result-driven operations;
Maintains the highest standard in USP’s Monograph development process;
Inculcates best laboratory practices and quality culture within the laboratory staff;
Gets involved in recruitment of new staff to support business needs, and contributes to the development of the next generation of scientific leaders;
Identifies training needs of the existing team members, develops and implements training plans for new staff;
Participates in the process of establishing goals and metrics for the team, ensuring alignment with the program unit goals and organizational goals, and evaluates performance against established goals
Participates in Performance appraisal process and gives feedback to the Direct reports in a timely manner;
Coordinates with the QA and safety departments to maintain the Lab as per GLP and safety practices;
Coordinate with P&L for procurement of chemicals, columns, glassware, etc. as per the need and availability;
Monitors the project material status such as sample received, under process, archival, disposal, etc.;
Completes the projects as per the time lines;
Communicates regularly with the CDL staff and Scientific Liaisons at USP-Rockville regarding the projects ;
Ensures that the team follows USP Policies and Procedures;
Performs other duties as assigned.
PhD. in Chemistry (preferably Analytical), Biochemistry or allied field such as Pharmaceutical science with minimum of 14 years of relevant industry experience.
Minimum of 8 years of experience with analytical characterization of drug substance and drug product is essential, out of which 5 yrs should be in a managerial position
Good interpersonal skill, proven leadership and staff management skills are must
A strong verbal communication, technical writing and networking skills are essential
Knowledge of compendial standards related to pharmaceutical industry
Knowledge of regulatory requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc.)
Strong business acumen combined with both management and leadership ability.
Experience in QC and batch release of pharmaceutical products and excipients
Experience with working globally in MNCs
Effective coach and mentor to staff. Ability to identify and develop talent.
Demonstrated stakeholder collaboration experience, with the ability to quickly develop and manage internal and external relationships and contacts.
Demonstrated research, technical, and analytical skills, as well as the ability to take in highly technical scientific information and make strategic recommendations quickly.
Ability to lead in a fast paced environment with changing deadlines and priorities.
Hyderabad, Andhra Pradesh, India
Job Category Scientific