Job Title:  Deputy Manager - Analytical Development

• Provide technical inputs for physicochemical analytical methodologies for monoclonal antibodies (mAbs).
• Responsible for delivering robust analytical methods that can be easily validated.
• Responsible for analytical method transfer to Quality control lab.
• Must actively work with the process teams to evaluate product quality using qualified physicochemical methods for mAb characterisation.
• Responsible for maintenance of the analytical labs including thorough documentation on the performance of all analytical equipment.
• Should have strong understanding of software’s used in NP-HPLC, Peptide mapping, RP-HPLC, SEC-HPLC, CEX, isoelectric focusing (cIEF), SoloVPE (for protein concentration determination), CE-SDS(Sciex) and mass spectrometry.
• Should have working knowledge and troubleshooting of Capillary electrophoresis systems, HPLC, UPLC and Empower,eLN and QMS
• A working understanding of Dynamic Light Scattering and Differential Scanning Calorimetry/CD spectroscopy methodologies will be preferable.
• Must be focused on usage of statistical tools to evaluate analytical method performance and robustness.
• Very well versed with analytical similarity studies as per RCGM, DCGI, EMA, MHRA and FDA requirements.
• Well versed with guidance documents for method qualification, method validation from various regulatory agencies, ICH, WHO and USP chapters as well as awareness to requirements of working in GLP environment.
• Providing appropriate technical inputs for analytical method development and validation, troubleshooting as and when required.
• Support in GMP investigations to address deviations in physicochemical method outcomes will be required.
• Responsible for authoring and reviewing technical reports, and portions of regulatory submissions to support IND enabling data to initiate early development clinical trials.
• Identify and communicate best practices within the CDMO function.
• Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development.
• Responsible for procurement of analytical consumables required for methods based on HPLC/UPLC/Maurice/ Sciex (CE)/ Solo-VPE etc.

Core Competencies

Building Effective Teams

• Empowers team members and encourages them to contribute their skills/ideas.
• Gets the right talent mix for the task. Shares credit and celebrates wins.

Process Management

• Strong organizational skills, including the ability to prioritize personal and direct report’s workload.
• Abreast with the latest technical innovations and familiarity with Regulatory expectations
• Able to analyze analytical data and provide inputs for process optimization.
• Resourceful, uses resources and people wisely.
• Very good understanding and implementation of the good documentation practices including paper and electronic record keeping.
• Sufficient industry experience in handling cross functional interactions.
• Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups.