Shire Technical Services Lead/Manager (PDTS) in Los Angeles, California
The Process Knowledge and Control (PKC) Lead will manage a small group of scientists or engineers to develop and execute the Continued Process Verification (CPV) plans at the Los Angeles site in accordance with the global CPV procedure and Quality by Design (QbD) methodology. He/She works closely with the Subject Matter Experts (SME), as well as the global Process Monitoring and Trending (PMT) network and IT team to set up and deploy the trending and analysis systems, facilitate proactive investigation of process shifts, and promptly communicate potential adverse trends that may impact product release to the site leadership as well as global team.
Essential Duties and Responsibilities
The individual in this position should expect significant day-to-day variability in tasks and challenges. Primary duties include but is not limited to the following:
Supervise and direct junior team members
Develop team members to achieve their goals and potential
Establish strategy for the PKC team and for the broader PDTS team
Influence global strategy around PKC and Continued Process Verification
Establish, implement, and maintain Operating Mechanisms and Methods for site CPV / Monitoring and Trending systems
Present and/or defend the CPV program or aspects of it to regulatory authorities
Facilitate trend review meetings with the strategic leadership team / site management
Report out metrics and adverse trends in the Technical Dashboard to the global PMT meetings
Assist in implementing proactive measures to reduce the risk of manufacturing issues
Support knowledge / best practices sharing
Ability to manage activities of departments in a matrix environment through managers who exercise full supervision in terms of cost, methods, and employees.
Understand and resolve project and technical difficulties, interface with internal engineering/ technical experts, and manage multiple priorities in a manufacturing environment setting.
Experienced in using statistical process control, control chart and process capability techniques.
Experienced in using PAT (Process Analytical Technology) techniques.
High level of customer orientation and organizational skills.
Excellent communication skills, verbal and written communication skills.
Education and/or experience
- Bachelor's Degree in a scientific discipline with a minimum of 6+ years of relevant experience. Preferable one of the years is in a supervisory role.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Some Clean Room and cool/hot storage conditions.
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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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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.