Job Description

What does it take to discover and develop cutting-edge medicines that address society’s biggest disease burdens? Thousands of scientists and physicians. Hundreds of global academic, biotech and digital partnerships. All working together. This is the community you’ll be part of when you join one of our R&D teams.

Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals.

Key Responsibilities

• Responsible for performing method feasibilities and validate robust analytical methodologies applied to innovative Oligonucleotides/peptide therapeutics. Strong experience in various chromatography techniques is a pre-requisite. Experience in mass spectrometry applied to biological molecules would be an asset.

• Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards.

• Accountable for documentation and submission of raw data in an appropriate data system (for e.g., LIMS test activation and results entry).

• Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.

• Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.

• Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory.

• Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).

• Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope.

Minimum Requirements

• Ph.D. in Analytical Chemistry or an equivalent qualification with a minimum of 1–3 years of experience, or M. pharm/M.Sc. with at least 8 years of experience within the pharmaceutical industry, specifically in analytical development. Strong expertise in oligonucleotide/peptide analytics
• Understanding of general regulatory and quality expectations. GMP experience is a must
• Good scientific background, communication skills including presentation and scientific/technical writing.
• Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software (e.g. Chromeleon) etc.
• Profound expertise in liquid chromatography separation techniques such as (RP, IEX and HILIC) is a must. Experience in Mass Spectrometry (ranging from mass confirmation to actual quantitative analysis of impurities and sequencing) is an asset

Skills Desired

Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model