Sr. Bioanalytical Data Scientist, PDMB (Pharmacokinetics, Dynamics, Metabolism and Bioanalytics) Regulated Robotics and Data

Job Description

The Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) Bioanalytics group in West Point, PA conducts regulated PK, immunogenicity and molecular assay development and validation, along with GLP and clinical sample analysis for the development of small molecules, vaccines and biotherapeutics. We are seeking a highly talented and motivated individual with experience managing and implementing Laboratory Information Management Systems (LIMS) within the regulated bioanalytical laboratory setting. Key responsibilities will include the development, validation, enhancement and oversight of LIMS systems or related modules that are used to track sample chain of custody records, analyze bioanalytical data, and handle data management. The candidate will also provide operational support of bioanalytical sample and data flow processes, and the validation of computerized systems. While the primary focus of the role will involve vaccines assays and related systems, where experience is preferred, activities may involve other modalities and methods supported by the bioanalytical labs at our Company or external partners.

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

Education Minimum Requirement:

• B.S. Degree in Biology, Chemistry (or related sciences), or Information Technology with at least 7+ years of industry experience, an M.S. with 4+ years of related experience, or a Ph.D. with 0+ years of related experience.

Required Experience and Skills:

• 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

• Experience in bioanalytical data management or related fields is preferred.

• Familiarity with data transfer processes and regulatory requirements in a clinical or laboratory setting.

• 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.

Preferred Experience and Skills:

• 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

• Intermedi