Key responsibilities would include-

- Design and maintain detailed project development plan

- Understand key dependencies including-

i. Mapping of resources and laboratory requirements across functional teams who are involved in multiple projects

ii. There must be a close interaction with the clinical, pre-clinical teams for the PK and immunogenicity assays and with the CMC team (both process and physicochemical analytical teams) for the in vitro cell based potency assays

iii. Define resource allocation in close contact with the Program Management team representing the Business Units on different projects

iv. Review the regulatory literature and understand how other sponsors have defined strategies for accelerated development of these analytics for different biologics

- Lead a regular executive assessment on the specific project and drive implementation of improvement actions, understand innovation and portfolio priorities

- Keep a pulse on industry trends and changes in technologies, innovation and project management

- Responsible for leading specific individual projects involving these analytics within the R&D novel and biosimilars portfolio

- Enable specific project optimization with set functional innovation priorities clearly linked to overall product development strategy

- Lead and justify aggressive timelines with well optimized understanding of available resources and respective capabilities of the individual functional teams involved in these analytical development activities.

Candidate profile-

- Candidate should be PhD in Biochemistry OR Biotechnology with sufficient knowledge on analytical methods used in biologics drug development

- A specialised PhD in Analytical Biochemistry would be of significant importance

- The following specific background is envisaged to provide a focused contribution for this lead role

a. Cell based potency assays for functional characterisation of protein therapeutics

b. Bio-analytical method development and qualification for large molecules, including ligand binding and immunogenicity assays

c. Very good experience in clinical research with a strong background on clinical pharmacology

- Must have 10-14 years experience in the R&D or quality industry with 6-10 years in R&D and / or quality innovation

- Experience in an operational or R&D role is a plus

- Broad experience in R&D project management and execution as well as innovation in R&D

- Expertise and Technical knowledge in Analytical Method Development for Pharmacokinetics, immunogenicity (meso scale discovery, Gyros, radio immunoprecipitation [RIPA]), cell based potency (including surface plasmon resonance) and cell based neutralizing antibody assays and host cell protein (HCP) analytics

- Specific focus of this expertise should exist for different biologics (including mAbs, protein therapeutics and peptides)

- Must have strong oral and written communication in the above mentioned specialised technical functions of biologics drug development

- Authorship in peer reviewed publications in reasonably high impact journals and IP (granted and or applications) in this specialisation would be an added advantage

- A very valuable "nice to have" is if one has been part of committees (for eg., AAPS) which draft white papers for bioanalytical methods (PK and immunogenicity and HCP) and cell based in vitro potency assays

- Must be very familiar with latest developments in analytical platforms like

a. BIACore

b. KineXA

c. Meso scale Discovery

d. Gyros

e. RIPA

f. Automation for liquid handling and for cell based assays

g. Any analytical methodologies for high throughput bio-marker evaluation

- The role drives integration of different aspects of bio-analtyical and in vitro cell based assay development including the following -

a. Strong understanding of regulatory requirements for analytical methods

b. Fully updated on all regulatory guidances/white papers published on analytical method validation and immunogenicity

-Excellent Written and Verbal skills in English are a must

- Fluency in one additional language is an advantage (German or French a plus).

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