Title:  Lab Specialist

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

Laboratory Projects is a global function within the laboratory network at West supporting other functions in analytical questions. In this role the job holder will act as Global SME for data gathering in the QA laboratories using Power BI.   As part of the Laboratory Projects team the job holder will execute projects and investigations in close collaboration with the lab Projects team located in Eschweiler and assist the QA site laboratories with investigations.  The job holder will also support the China DMF registration program through organizing, tracking and reporting stability studies of West´s elastomeric closures. In close collaboration with the China DMF registration teams in Europe and Asia.  

Essential Duties and Responsibilities:

• Act as Global SME for data gathering in the QA laboratories.
• Build the required templates for easy retrieval of data from SAP system.
• Act as point of contact to answer Power BI related questions related to laboratory data.
• Coordination and support for generation of global laboratory metrics

• Support to build a stability management process by authoring the required protocols and templates as requested. This includes standardized protocols, framework/template for reporting out reports. Following Work Instructions for Handling OOS (with collaboration from other functions Lab & QA).
• Coordinate open tasks within the Laboratory Projects team in Waterford
• Support with managing and maintaining the stability chambers at the Waterford plant in accordance with procedures and requirements
• Support with managing the storage of stability samples at off site storage locations
• Support with managing the stability studies through review of Master Specifications & Submission Scope, drafting stability study protocols, preparing samples and managing stability studies using LIMS  and maintaining and managing test reports.  Review drafted protocols with stakeholders (QA, Lab and RA, Exton Lab team as required) and make necessary amendments as agreed upon.
• Coordinate samples submission to labs
• Monitor the testing progress and results availability
• Forecast of stability test demands (i.e lab/Chamber capacity)
• Prepare stability testing summary reports at different time points and the final report, ensure proper communication / status transparency for the project management and Steering Committee always
• Facilitate investigations as needed with Lab and QA as well as relevant stakeholders for any OOS in studies
• Support with particle identification using the µATR method
• Compliance with all local site company policies, procedures and corporate policies
• Act in accordance with the company’s guiding principles and adherence to the corporate code of conduct
• Other duties as assigned

Education and Experience:

• Degree (Master or PhD) in chemistry, pharmacy or related scientific discipline
• 3 years of experience in a pharmaceutical, pharmaceutical packaging or medical device / delivery systems company
• Professional experience in conducting stability studies in a pharmaceutical environment is a plus

Knowledge, Skills and Abilities:

• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.
• Effective communication & interpersonal skills
• Working in global, cross-functional teams
• Ability to work in a rapidly moving and partly undefined (“grey area”) regulatory environment
• Patient and tenacious, proactive working style
• Background in analytical laboratory testing and in Compendia regulations is an advantage.
• Background in Industry Standards applicable to the pharmaceutical (packaging) industry, such as ISO, ASTM, Compendia, ISPE, ICH is an advantage
• Strong Quality and customer-focused mind-set

Physical and Travel Requirements

•  Less than 10% Travel Requirement

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.