Deputy Manager /Manager - LC-MS Characterisation

Role & responsibilities

• Provide technical inputs for LC-MS characterization methodologies for monoclonal antibodies (mAbs).
• Responsible for delivering robust LC-MS methods that can be easily qualifiable.
• Candidate should be responsible for LC-MS based method development using either TOF or QTOF or Orbitrap.
• Candidate should have through knowledge on identification of variants Targeted approach/ non-targeted approach.
• Candidate should have knowledge of following method development as well as understanding of the method qualification of below methods.
• Intact Mass
• Reduced Mass
• Multi attribute method
• Post translation modification identification like: Oxidation, Deamidation, Glycation, Glycosylation, lysine variants, etc
• Sequence variant analysis
• Peptide mapping fingerprint
• Must actively work with the process teams to evaluate product quality using qualified LC-MS methods for mAb characterization.
• Responsible for maintenance of the LC-MS lab including thorough documentation on the performance of all analytical equipment.
• Candidate should have knowledge of higher order structure analysis like CD, FTIT, FLR spectroscopy.
• Candidate should have knowledge of different software for data analysis like Protein matrix and other.
• 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.

Preferred candidate profile

• PhD in Biochemistry/Biotechnology with 4-8 years or MSc in Biochemistry/Biotechnology with 8 to 12 years of work experience developing and validating physicochemical methods for mAbs in biopharma/biotech or relevant contract research labs.
• Preference will be for personnel having prior experience in leading a team in biopharma organizations that focus on physicochemical characterization of mAbs.
• Experience in LC-MS method development, qualification are highly desirable. This includes vast experience in different analytical tools including Intact mass, Reduced mass, identification pf PTMs, Multi attribute method, Sequence variant analysis, peptide mapping, DLS, DSC, CD spectroscopy and spectrophotometry-based methods.
• Significant experience in assessment of product purity, Impurity and identity for different mAbs, bi-specifics, receptor fusions and antibody fragments will be valued.
• Having experience of statistical software like GraphPad, JAMP, etc.
• Technical competence in appropriate scientific discipline or technology will be of great value.
• A strong working understanding of monoclonal antibodies
• Strong Cross functional communication skills is highly desirable.
• Excellent oral and written communication and interpersonal skills will be desired.