Shire Senior Development Specialist in Lexington, Massachusetts

Primary Duties

  • As a member of Analytical Development Method Development team, he/she will work on method development, qualification and characterization of drug substance, drug product and reference standards for biological programs.

  • Responsibilities include designing experiments per ICH guidelines, flawless execution of experimental studies, documenting results accurately in the laboratory notebooks, writing and reviewing technical reports, generating test methods to support high throughput and QC testing groups, participate in analytical, process development and QC meetings and discussions, etc.

  • Provide quality and regulatory support as needed and actively participate project teams

  • Applies technical knowledge under minimal supervision to independently execute method development and assay remediation activities Responsibilities 60% Execution of experimental studies30% Documentation including writing protocols and reports10% Training and presenting data Education and Experience Requirements BS with 6+ years of industry experience, or MS with 4-6+ years of industry experience in analytical chemistry, biochemistry or other biological/analytical discipline.Experience in method development, qualification and validation of analytical methods for biologics. Key skills, Abilities, and Competencies

  • Strong analytical and problem solving skills are required

  • In-depth knowledge of HPLC, UPLC, LabChip, SoloVPE, and enzyme activity measurements, including both theory and practice 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

  • Complex problem solving skills

  • Understanding of ICH, USP and GMP guidelines

  • Flexible to work on multiple projects

Internal and External Contacts

  • Internal and external Shire departments

  • CROs and CMOs

Other Job Requirements

  • Available to participate in early or late meetings/teleconferences

  • Familiarity in Microsoft Office (word, excel, and powerpoint) and JMP

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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.