Shire Process Knowledge and Control Lead in Social Circle, Georgia

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.

Description:

  • Coordinate with BioAnalytics group and process SMEs to establish data hierarchies for process monitoring and trending applications

  • Work with global team to develop and manage process monitoring and control strategies, encompassing implementation of appropriate statistical techniques to timely signal recognition, communication, and response

  • Manage CPV (Continued Process Verification) activities for all products on site

  • Facilitate QbD methodologies including topics such as PFMEA revision and process knowledge lifecycle management

  • Work with Global team to develop procedures and training for the use of BioAnalytics tools by the site technical team to support activities such as robust CPV, Design of Experiments, and methods for conducting ad hoc queries (investigational).

  • May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding study design and other unique problems.

  • Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.

  • Maintain current knowledge of relevant Quality System Regulations (QSR) and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.

  • Have an in-depth knowledge and understanding of GMP’s and related regulations. Is able to provide expert insights into such regulations so as to facilitate efficient product registration and to interact with Regulators during inspections.

  • Support the implementation of process improvement projects using project management tools and skills.

Independently plan and execute a series of design and/or technical tasks that may not be well-defined with limited supervision

Requirements:

KNOWLEDGE, SKILLS AND ABILITY:

(List the MINIMUM knowledge, skills and ability required to perform the essential functions of the position):

  • Proficiency in relevant statistical analysis techniques

  • Excellent technical writing and interpersonal communication skills for cross functional audiences

  • Strong computer skills (MS Word, MS Excel, MS PowerPoint, Minitab)

  • High level competency in problem solving and investigations with ability to analyze and interpret scientific and statistical data and draw appropriate conclusions

  • Previous Six Sigma Greenbelt certification preferred

Qualifications:

  • Bachelor's degree in a scientific discipline with at least 4 years or MS with at least 2 years relevant experience, or equivalent.

  • Experience with statistical tools such as Minitab, SAS JMP, Discoverant or SIMCA is preferred. Experience in GMP/QSR environment, cross-functional and global teamwork, and independent experimentation in method development and validation is preferred.

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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 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.

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 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.