Hiring for Process R&D Scientists to lead NCE / small molecules, API-CRDMO, Projects

Objective / Purpose of the Role:

To take on the leadership of a team of scientists focused upon process research, process development, scale-up and manufacture of small molecule Starting Materials, Intermediates and APIs. Taking charge of the technical, operational and strategic aspects of the team including:

• Leading a team ranging from 6 to 20 scientists , taking comprehensive responsibility of on time delivery of projects with minimal or no supervision. The role requires complete ownership of the project, client management & cross-functional team coordination.
• Enhancing the capabilities of the team through training, technical coaching and targeted recruitment to ensure the team has all of the capabilities required to deliver customer projects.
• Driving growth of equipment and facilities to expand the service offering.

Key Responsibilities:

• To lead a group of 6-20 scientists, ensuring the consistent application of strong scientific principles and the application of appropriate technologies.
• Handling multiple programs, leading, coaching and mentoring the team leaders by providing suggestions on all aspects of the projects.

Project Delivery:

• To manage NCE development projects involving route scouting, process feasibility, process development and optimization and robustness to ensure the developed processes are scalable and robust.
• To review the data generated by the team, providing technical guidance and suggest course correction, wherever required.
• Respond to Requests for Proposal /Quotation by preparing/reviewing technical proposals for new enquiries. Including raw material; resource and time estimations for the completion of the project. Supporting pre-sales and business development teams by the provision of technical information.
• Reviewing and approving process development approaches and on need basis reviewing the reports and communications shared to the customer.
• To collaborate and resolve issues with larger and broader CFTs. Supporting program management and manufacturing teams to deliver projects on-time and in full.
• To be responsible for prescribed data generation and timely completion and review of:
• Process Development Reports
• Tech Transfer Documentation
• Investigation Reports
• Customer Updates etc
• Taking complete ownership for successful delivery of the assigned project(s).
• Cross-functional coordination: Providing guidance to Team Leaders for the coordination of Cross Functional Teams (CFT) from Proposal stage (RFQ) to delivery of the product(s). Ability to work with several departments, including Analytical Research and Development (ARD); Equipment mapping team; Sourcing team (SCM); Quality team (QA & QC); Process Engineering team (PE); Technology Absorption team (TAT) and Manufacturing team (Mfg) for smooth execution of project and delivery of product.
• Communication: Excellent communication, both verbal and written with an ability to ensure on time responses to client within a stipulated time.Ability to communicate with clients directly or through program managers (PM)/Business Development (BD)/Pre-sales.
• Documentation: Ensuring high quality documentation at all time through review of weekly reports; Process Description Documents (PDD); Technical Packages (TP), Process Development Reports (PDR) and other miscellaneous documents.
• Safety & Laboratory Maintenance: To ensure the highest standard of safety practices are maintained by all working in the laboratory, including maintaining a safe and functioning working environment.
• Quality & Compliance: To ensure the team complies with all SOPs, guidelines and training.
• Team Management & Development: Guide, train, and support team members to ensure quality work is delivered as planned. Ensuring proper distribution of tasks and resource utilization. Identify skills and mentor associates; assign responsibilities and follow up; feedback at regular intervals and maintain a record. Provide leadership and direct contribution to functional and/or cross-functional improvements.
• Department Initiatives: Active participation in all management initiatives, group discussions, monthly seminars and various meetings organized for the improvement of services and functioning of the department.

Experience

Ph.D. with more than 5 years experience in peptide synthesis and or scale-up in the API and/or CDMO Industry, of which minimum 3 years should be in CDMO.

Post Doctorate desired, but not mandatory.

Key Competencies (Technical, Functional & Behavioral)

Technical

• Background in synthetic organic chemistry with an expertise in route and/or process development for the manufacture of small molecules.
• In-depth knowledge of Process R&D and scale-up as well as cGMP & regulatory requirements.
• Use of parallel experimentation for screening; statistical, and other modelling tools (e.g. DoE, Kinetics) for process development and robustness studies to support scale-up.
• Keep abreast of new technologies and approaches and techniques in the field of synthesis and process research, maintains awareness of current literature and scientific trends.

Functional

• Leadership, inspire and motivate teams to achieve goals; provide guidance and direction; foster a collaborative and inclusive work environment with a strong focus on scientific excellence
• Innovative Thinking, think critically, anticipate challenges and develop innovative solutions
• Critical Information Seeking
• Planning & Organizing, multi-tasking and leading multiple activities
• Execution Excellence, flexibility to adapt to changing priorities; willingness to embrace new ideas and approaches

Behavioral

• Attention to detail
• Strong interpersonal and communication skills, ability to articulate complex ideas clearly and concisely
• Customer focus and centricity
• Collaborative mind set
• Focus on individual and team development