This position reports to the Head of Manufacturing Sciences Purification and is responsible for providing scientific support to the manufacturing group at the Los Angeles Facility. The Purification PDTS team is responsible for investigating and troubleshooting adverse events within the B8 manufacturing facility, assisting our quality and manufacturing partners in troubleshooting issues, supporting regulatory inspections by defending technical decisions to regulatory agencies, and maintaining process compliance. Essential Duties and Responsibilities
The individual in this position should expect significant day-to-day variability in tasks and challenges.
- Provides clear direction on product development requirements to meet exceptions. May be sought out by other teams and individuals to offer technical advice; may act as coach, mentor, and technical advisor to junior members within the discipline.
- Develop products/processes (design, quality improvements, research techniques, etc.) incorporating multiple tasks within area of expertise.
- Independently plan, execute and manage projects/programs that both span multiple disciplines and incorporate novel methods, techniques or approaches. Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures. Analyze executed designs and results and modify them to increase product/processes acceptance, quality and reliability.
- Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems. Contribute to technical feasibility analysis, which incorporates multiple disciplines where new and unproven methods and technologies are required. Generate innovative solutions to highly complex problems where little clear precedence exists. Incorporate advanced theories, methods and technologies from around the world to develop new innovative products/processes.
- In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
- Present research results at external conferences, publish articles in journals and/or file patents.
- Support the site Process Monitoring, Compliance Excellence, and Continuous Improvement programs.
Education and/or experience
- Both practical and theoretical knowledge of the purification of plasma proteins.
- Ability to solve problems of a technical and scientific nature.
- Ability to handle multiple tasks concurrently while paying attention to details.
- Self-motivated and takes personal responsibility for getting the job done. Able to manage projects.
- Excellent ability to analyze and interpret scientific, and statistical data and draw appropriate conclusions.
- Strong computer skills (MS Word, MS Excel, MS PowerPoint, Minitab).
- Good laboratory skills.
- Strong interpersonal communication. Strong verbal and written communication skills. Strong presentation skills. Understand and articulate how own role ties within function or discipline.
- Experienced understanding of GxP and related regulations.
- Strong assessment and troubleshooting skills.
- Ability to lead multidisciplinary teams in the execution of a project.
- Six Sigma Greenbelt certification preferred.
- Bachelor's Degree in a scientific discipline with at least 7+ year's relevant experience.
- Master's Degree in a scientific discipline with at least 6+ year's relevant experience.
- PhD in a scientific discipline with at least 4+ year's relevant experience.
- Must be able to push/pull 50 lbs. and lift/carry up to 25 lbs.
- 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.
- Will work in a cold, wet environment.
- Must be able to work multiple shifts, including weekends.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.