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 Ophthalmic.
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.
The position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Shire additional capacity for fractionating, purification, and fill and finish for its biologic medications. This position will play a key role in start-up operations supporting manufacturing in areas like documents authoring, deviations investigation and CAPA determination and change controls implementation
Essential Duties and Responsibilities:
Drive manufacturing deliverables to ensure successful commercial operations, including:
– Lead CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by:
– Lead problem solving and root-cause analysis sessions
– Interact with Quality, Engineering and Tech Service units
– Manage complex investigations using DMAIC tools
– Ensure effective implementation of corrective and preventive actions
– Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls, etc.)
– Train staff in general manufacturing activities
– Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks
– Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls
– Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability
– Stay current with biopharmaceutical industry best practices and technologies
– Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects.
- Strong problem solving and analytical skills are required.
- Possess knowledge of core manufacturing principles and support systems
- Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
- Self-driven individual that requires minimal supervision
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint), Trackwise.
- Prefer proficiency in Automation Control Systems, EBM (Electronic batch Record), PI Historian
- Prefer knowledge of Lean Six-Sigma methodology
Education and/or Experience:
Bachelor of Science degree required (prefer Chemical Engineer, Biological/Biotech Engineer or Biotechnology)
0-4 years of work experience
Professional (GMP industry) experience ideal but not required
- May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry).
- May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
- May be required to work weekends, evenings, off-hours, extended periods of time.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law – Supplement
Pay Transparency Policy
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.