This is an entry level scientist position in the Analytical Development group working on proteins, monoclonal antibodies, and other biologics. The responsibilities include method development, transfer, and qualification, and routine sample analysis to support process development and pilot production. The analytical methods routinely used include UV-Vis spectroscopy, ELISA, qPCR, activity assay etc.
- Develop, qualify, and transfer analytical methods. Work with Quality Control and other Operations groups to trouble-shoot and improve existing analytical methods.
- Design experimental plans based on the defined deliverables, planning the activities to meet the project timelines by working closely with project managers.
- Routine sample analysis to support process development. Work with Process Development and Manufacture groups to trouble-shoot process challenges.
- Record results in notebook accurately, clearly and regularly.
- Prepare protocols and reports and test methods as needed.
- Present and discuss data at project and department meetings.
- Maintains laboratory equipment and supplies
- Maintains and ensures safe laboratory environment and work practices.
Education and Experience
- The individual should have a bachelor’s degree in a relevant scientific or engineering field.
- Hands-on experience with UV spectroscopy and ELISA or qPCR is required
- Proven ability to design and execute the studies based on the deliverables.
- Excellent writing, communication and presentation skills required
- Working knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment is preferred.
- Routine use of MS Excel, MS PowerPoint and MS Word is essential.
- Ability to work in a fast paced environment
- Excellent organization and planning skills
- Ability to function in a rapidly changing environment and balance multiple priorities moving from one project to another as priorities change
- Lifting, walking, sitting for long periods and repetitive hand motions
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.