Data Scientist Pharmaceutical

DATA SCIENTIST PHARMACEUTICAL WARREN, NJ 100% Remote Position. Contract with option to convert to full time employee. Project Description:

• We are looking for a MSAT Process Data Scientist to join the Product Stewardship team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department.
• The MSAT Process Engineering Data Scientist is a key member of the Manufacturing Science and Technology organization, responsible for management and analysis of process data from the Client Cell Therapy global manufacturing network.
• The MSAT Process Engineering Data Scientist works with teams of highly skilled engineers and scientists in the Cell Therapy unit to complete projects that maximize the value of our Cell Therapy data.
• They will be responsible for the creation and management of custom-built and off-the-shelf software tools to automate, standardize, present, and document data acquisition and analysis workflows under the direction and guidance of the Cell Therapy CMC Data Steward.
• They will support all aspects of product lifecycle management, working with partners in multiple programs in the client's Cell Therapy clinical development and commercialization pipeline.
• The role specializes in manufacturing and manufacturing test data but collaborates across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

• Prepare reports to support GxP use of data, including health authority interactions, investigations, tech transfers, and product development through the creation and review of 'single source of truth' datasets.
• Create tools and author reports to ensure that the client CTDO data assets remain accurate, complete, attributable, consistent, and available across multiple sites.
• Collaborate with Data Owners, Data System Owners, Data Stewards, and other Data Scientists to ensure that the client CTDO data assets remain available, enduring, and consistent throughout their analysis lifecycles.
• Develop, deploy, and maintain global Manufacturing data processes, including scripts, standards, work practices and automation.
• Work with engineers and scientists in the client manufacturing network to maintain and expand availability of project-critical data.
• Conduct reconciliation, auditing, and analysis of process data in support of our team's responsibilities for routine product process and quality monitoring.
• Collaborate with team members to develop, deploy, and maintain global MSAT process analytic dashboards from multiple manufacturing sites.

• MSc or BSc in Computer Science, Chemical/Mechanical/Biomedical Engineering, Bioinformatics, Business Analytics, or equivalent with minimum of 5+ years of relevant experience.

• 2-3 years' experience in an analytic or reporting role utilizing Python or R.
• Experience working with software version control and collaborating with team members through a SCCS.
• Ability to work effectively in cross-functional teams to meet deadlines and prioritize responsibilities.
• Excellent problem-solving skills, including issue resolution, root-cause investigations, and CAPAs.
• Abilities to assess and effectively communicate project risk and to develop contingency/alternative plans.
• Able to self-manage projects and escalate relevant issues to project lead and line management.
• Detail-oriented, with excellent organizational skills and verbal/written communication skills.
• Strong interpersonal and leadership skills and a desire to improve them further.

• Experience with cell therapy development and/or manufacturing support/monitoring.
• Experience managing quality in a team code base.
• Experience working with cell therapy or biologics data used in regulatory submissions.
• Experience with commercial product support, i.e., post-marketing commitments, validation, and comparability.