Client is a leading and vertically integrated global pharma company based out of India with a strong presence in number of markets including EU.
Client is one of India's exciting and broad-based organizations with strong technology, development and manufacturing footprints in generics, biosimilars, plasma operations and hormones.
The Head of Analytical Development will be a key member of the senior management team, leading a group of scientists that will define and manage the analytical development and method transfer in support of in process, release and stability testing of drug substance and drug product for multiple early stage and late stage biosimilars development programs. The candidate will provide oversight and participate in the management and monitoring of product development and stability testing activities; and will work with process, quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities including BLAs/MAAs.
This scientific leader will be a key enabler with important contributions to submissions in European and US FDA in years
He will also resource analytical and strategic support for R&D process development teams in biopharma division, new drug discovery, stem cell and gene therapy units covering a wide range of early stage candidates in research and preclinical stages.
Functions and Objectives
As the Head of Analytical Development you will be responsible for the development and qualification of analytical methods for the characterization of recombinant proteins, as well as for in-process control and final quality control upon product release for clinical as well as commercial lots. An introduction to such duties can be found below:
1. Lead and manage the overall scientific, technical and operational efforts of a group of up to fifty analytical scientists with delivery of analytical testing strategy and methods, timely data review and oversight, and process knowledge needed to meet the company's development program milestones.
2. Build an excellent team with deep expertise in characterization and analytical testing of proteins to aid in the identification of scientific and technological opportunities to improve upon product testing strategy, method robustness, analytical testing productivity and quality compliance.
3. Provide analytical support of process development and process optimization in USP and DSP development groups.
4. Supervise and guide development/optimization of analytical methods for testing and characterization of bio-pharmaceutical products, including biochemical assays, HPLC, CE, electrophoretic and immunochemical methods and methods related to drug product safety.
5. Develop, qualify and transfer analytical methods that will be used for protein characterization, as well as Drug Substance / Drug Product lot release testing according to relevant ICH guidelines and GMP regulations.
6. Provide the direction for the business and R&D development strategy by laying out product Critical Quality Attributes and contribute to product selection for development.
7. Experience in formulations, device development, selection of primary packaging material and conducting container closure studies.
8. Manage method transfer and preparation and approval of SOPs, validation protocols and method validation reports; review and revise SOPs; review and contribute to regulatory filings.
9. Ability to manage and support atleast eight projects at different stages of product development early clone selection, pre-clinical and clinical development.
Qualification and Job Requirements:
To be successful as the Head of Analytical Development we are looking to identify the following on application:
1. PhD in chemistry, biochemistry, biophysics or biology with significant "industry" based experience in development, qualification, validation and transfer of chromatographic, spectrophotometric, electrophoretic, and other relevant methods for biologics / biosimilars in an industrial bio-pharmaceutical environment.
2. Experience of working and leading an analytical development team is a must as well as the ability for troubleshooting of complex technical and scientific questions.
3. Proven supervisory and managerial skills are essential with a high level of expertise with regulatory compliance in biologicals product development. You must be able to perform in a fast paced multi product environment.
4. Authored papers in leading journals, on which he/she is the actual first author or major contributor (i.e., drafted manuscript, responded to reviewers' criticisms etc.).