Sr. Bioanalytical Data Scientist – Pdmb – Pharmacokinetics – Dynamics – Metabolism and Bioanalytics – Regulated Robotics and Data
| Company | Merck |
|---|---|
| Location | North Wales, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | |
| Experience Level | Senior, Expert or higher |
Requirements
- Extensive experience utilizing or implementing custom or commercial Laboratory Information Management Systems (LIMS) in a regulated bioanalytical laboratory.
- Experience working with multiplex and/or singleplex bioanalytical assays, used for the support of vaccines or drug programs in development (e.g. immunogenicity, cell based assays, PK, PCR serotyping, etc.).
- Self-motivated learner with the ability to quickly analyze and interpret complex processes and problems and propose creative solutions
- Direct experience participating in computer system validations
- Strong collaborator, possessing both excellent verbal and written communication skills
- Capable of working independently under project timelines
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
- Proficiency in using data management systems and tools (e.g., Watson, LabMatrix).
- Ability to manage multiple projects and prioritize tasks effectively.
- Detail-oriented with a commitment to maintaining data integrity and compliance.
Responsibilities
- Participate in the development, testing, validation, and implementation of LIMS systems or related upgrades to meet the needs of various bioanalytical single plex and multiplex assays.
- Collaborate across a diverse group of stakeholders and partners to understand the end-to-end sample tracking, data analysis, data archival, and data submission needs for internal and external laboratories and developing appropriate strategies and solutions.
- Manage day to day LIMS activities for method qualification/validation and clinical study support including, but not limited to, user training, troubleshooting, study setup, sample reconciliation, and management of clinical data transfers in line with regulatory data standards.
- Identify and implement new capabilities that support data handling or data integration into bioanalytical or downstream systems (e.g. electronic lab notebooks, LIMS, clinical databases, biospecimen management systems, etc.).
- Execute computer system validations associated with laboratory computerized systems and equipment
- Operate within a regulated bioanalytical laboratory, participating as needed in regulatory audits as a systems subject matter expert
- Develop departmental SOPs and related computer work instructions associated with bioanalytical laboratory systems.
Preferred Qualifications
- Experience working specifically with vaccines bioanalytical assays, primarily those involved with immunogenicity or molecular based assessments
- Experience driving improvements for regulated bioanalytical data workflows either directly within a LIMs system or through other applications (e.g. Microsoft Excel)
- Working knowledge of data standards (e.g. CDISC) and applicability to bioanalytical data
- Intermediate level of Microsoft Office Suite skills.