Senior Assay Development Scientist (Full-/Part-time) (all genders) 1

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

As an (Senior) Assay Development Scientist, you will serve as a subject matter expert (SME) in method development, validation, and the feasibility/transfer of testing required for the manufacture of clinical and commercial products. Your responsibilities will include: 

• Understanding GMP requirements for validation, transfer, and documentation. Act as subject matter expert in analytical methods and provide guidance to Associate Scientists and study managers.
• Applying laboratory techniques and skills to conduct experiments aimed at solving a variety of specific problems.
• Leading the development, validation, and feasibility/transfer of methods, ensuring timely initiation and completion of studies.
• Preparing and reviewing protocols, reports, SOPs, laboratory records, technical specifications, and other related documents.
• Executing methods in the lab for assay development/validation, feasibility/transfer.
• Performing testing in accordance with SOPs and regulations (cGMP)
• Transferring GMP assays to the routine team and provide training to the Associate Scientists, study managers, report writers and QA.
• Operating and maintaining lab equipment as required by SOPs and testing procedures..
• Utilizing applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc)
• Leading general change control and resolve deviations by completing event records
• Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment
• Ensuring current regulatory requirements and technical needs of internal and external clients are appropriately met.
• Maintaining strong communication skills to effectively interact with internally and externally stakeholders.
• Engaging directly with clients.
• Performing other duties as assigned.
  
  Who You Are:

• Academic studies in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.), with at least 10+ years industry experience

• Board working knowledge of filed and experience with relevant laboratory practices, techniques, equipment, materials and mathematical calculations.
• Intermediate skills in applicable computer programs
• Experience of method development in a pharmaceutical laboratory or similar field
• Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.
• Experience with some or all of the following technical disciplines:
• Liquid Chromatography (SEC, RP, IEX, etc.),
• Mass Spectrometry (Intact Molecular weight, Peptide mapping, Disulfide mapping, Glycan Profiling, N-/C-Terminal Sequencing)
• Capillary Electrophoresis Methods (CE-SDS, cIEF)
• qPCR
• Compendial assays, etc.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!