Shire Analytical Development Specialist in Lexington, Massachusetts
As a member of Analytical Development High Throughput Testing team, he/she will work with a team of scientists in executing various analytical methods as part of the routine testing lab to support various biological therapeutic products. These include release and characterization testing support in a compliance-based environment, following established test methods and protocols.
60% of time: Execution of experimental studies
30% of time: Documentation including data analysis, summarizing data and documenting results
10% of Time: Training and presenting data
Education and Experience Requirements
- A BS with documented experience of analytical work for 1-3 years in a biologics industry laboratory.
Key skills, Abilities, and Competencies
Experience with separation based HPLC/UPLC methods and demonstrated experience of working with Empower software. Preferably experience with one or more of following methods: SEC, RP-HPLC, peptide map and glycan map.
Demonstrated experience of working with plate based and gel methods. Preferably experience with one or more of following methods, ELISA, SDS-PAGE, Western blot, receptor binding.
Proficiency in diverse analytical techniques is required along with basic biochemistry laboratory techniques. Computer competency is essential with emphasis on spreadsheet-based software. Effectiveness will be based on his/her ability to support lab functions and to clearly and accurately document and communicate data in written form and verbally to colleagues as well as superiors. The ability to adhere to strict guidelines when applicable is required.
Ability to work successfully in both a team/matrix environment as well as independently.
Ability to work in a fast pace environment, manage priorities, and flexible to work on multiple projects
Knowledge of cGMPs, regulatory guidelines and good laboratory practice are essential
Excellent written and verbal communication skills are essential.
Complexity and Problem Solving
Able to work independently with some supervision
Complex problem solving skills
Flexible to work on multiple projects
Reviews work for technical soundness and accuracy.
Internal and External Contacts
- AD line function management, AD group, AD project/program team(s)
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.