Technical Lead Mass Spectrometry (LC-MS) For protein characterizatio

Job Title:

Technical Lead Mass Spectrometry (LC-MS) for protein characterization

Department and Location:

Contract Development and Manufacturing Organisation (CDMO) Lambda Therapeutic Research Ltd – Ahmedabad

Designation

Sr. Manager/Manager/Deputy Manager

Reporting To:

Group Lead- Physico-chemical characterization

Purpose of Job:

The candidate should develop Mass spectrometry based physicochemical methods within the Analytical Sciences group. The role entails utilization of the prospective candidate’s vast technical experience to lead a team that will be focused on development, qualification of mass spectrometry-based characterization methods for monoclonal antibodies (mAbs) using CHO or murine myeloma cell lines as expressions systems.

Specific Job Responsibilities:

• Planning and execution of experiments for protein characterization using advanced techniques like LC-MS for Multi attribute monitoring.
• Maintain equipment and instruments in coordination with vendors and internal instrumentation team and manage instrument installation
• Candidate will be responsible for LC-MS based method development using either TOF or QTOF or Orbitrap.
• Acquire mass spectrometry data using advanced software tools and generate reports
• 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 (MAM)

- 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 thorough knowledge of higher order structure analysis like CD, FT-IR, FLR spectroscopy.
• Candidate should have thorough knowledge of different software for data analysis like Protein matrix, Sim Glycan and other.
• Ability to establish higher order structure assessment techniques like HDX- MS
• Responsible for maintenance of the Mass spectrometry labs including thorough documentation on the performance of all analytical equipment.
• Should have working knowledge and troubleshooting of Capillary electrophoresis systems, HPLC, UPLC and Empower,eLN and QMS
• 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 characterize aberrant impurities or profiles.
• 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 mass spectrometry-based methods.

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.

Relevant Functional/Technical Skills or Industry Experience

• Experience in handling high resolution mass spectrometers (Q-TOF/Orbitrap) and familiarity with different software platforms for intact mass deconvolution, reduced and non-reduced peptide mapping and glycan analysis.
• Experience in top-down, middle-down and bottom-up approaches of protein analysis and adequate experience with multi attribute monitoring platforms.
• Experience with softwares like proteome discoverer, protein metric, Byonic, Biopharma finder etc.
• Experience with separation techniques with strong chromatography background.
• Having experience of statistical software like GraphPad, JAMP, etc.
• 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.

Relevant Professional / Educational Background:

• PhD in Biochemistry/Biotechnology with 4-8 years or MSc in Biochemistry/Biotechnology with 8 to 12 years of work experience developing and qualifying mass spectrometry based physicochemical characterization 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 MS based physicochemical characterization of mAbs.