Shire Analytical Development Specialist in Lexington, Massachusetts

Primary Duties

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.

Responsibilities

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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Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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.