Shire PKC Lead/Manufacturing Scientist in Los Angeles, California

This position is part of the Continued Process Verification team within the PDTS organization at the Los Angeles Facility. The primary purpose of the CPV is to ensure the manufacturing process remains in a state of control, as well as to identify opportunities for enhanced process control. Using its understanding of the biochemical and technical aspects of the process and combining this with statistical and analytical expertise, the team is responsible for setting up the monitoring and trending program and assisting in troubleshooting adverse process trends by proactive data analyses and by doing so enhance process control. He / She will work closely with the Subject Matter Experts and IT team to develop systems for the trending and analysis of process data including tools for the aggregation and analysis of data, communicate and assist in the investigation of negative trends.

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:

  • Facilitate Discoverant implementation and coordinate activities with SMEs and IT team

  • Assist in writing the CPV plans and execution of monitoring and trending program

  • Perform data analyses using applicable analytical systems

  • Ensure the maintenance of data analytics and promptly address issues to IT for the continuity of CPV

  • Lead trend review meetings with Manufacturing, Quality and Technical Services

  • Maintain and update CPV plans as necessary

  • Write technical reports from CPV program

  • Assist in the investigation of adverse trends and implementing proactive measures to reduce manufacturing risks

Qualifications

  • Experienced in using statistical process control, control chart and process capability techniques.

  • Strong ability to analyze and interpret scientific and statistical data.

  • Strong computer skills (MS Word, MS Excel, MS PowerPoint, SharePoint, Minitab, Discoverant, SQL coding experience preferred).

  • Strong interpersonal, verbal and written communication skills.

  • Strong presentation skills. Understand and articulate how own role ties within function or discipline.

  • High level of customer orientation and organizational skills.

  • Capable of analyzing and solving complex problems through innovative thought and experience, self-motivated and takes personal responsibility for getting the job done

  • Able to work independently and within a team, and follow specific instruction, to accomplish the tasks.

  • Experienced understanding of GxP and related regulations.

  • Understanding of biochemistry or protein separation, plasma protein knowledge preferred.

Education and/or experience

  • Bachelor's Degree in a scientific discipline with at least 2-4 years relevant experience or Master’s required.

  • QSR research lab experience and/or GMP experience.

Physical Demands

In general, the position requires mostly sedentary work and some walking around observing conditions in the facility.

Working Environment

  • Inside working conditions.

  • 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.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, 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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.