- Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
Provide support for daily operation of the lab and control of work flow. Implement testing standards and policies. Supervise safety measures of lab. Assist lab personnel and enhance their performance.
- Ensure completion of all testing, including special project/protocol testing in a timely and appropriate manner.
- Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications. Monitor the testing techniques and accuracy of all records and documentation that is done in the lab. Perform review of testing records as needed.
- Provide subject matter expert review of protocols and technical study reports as needed.
- Coordinate with sister sites for implementation of company-wide procedures and supply of critical reagents.
- Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
- Maintain expenses at or below budget for the lab.
- Assure a safe and non-discriminatory working environment for employees.
- Ensure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and insure employees have development plans.
- Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the lab operation.
Assure equipment maintenance and calibration, and internal audits are performed on schedule.
Must know operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical manufacturing labs. Must possess excellent supervisory and interpersonal skills and be able to communicate with subordinates, peers and managers.
Bachelors Degree in Biochemistry, Chemistry, or biological science with Analytical Chemistry or Laboratory coursework. Five to seven years of experience in pharmaceutical laboratory with emphasis on biologics testing. Two years of supervision experience preferred.