Job Description

Position Summary

The Associate Director, Advanced Process Analytics & Data Strategy is a technical individual contributor role within PDSM. The primary expectation is hands-on technical contribution applying data science, process modeling, and data architecture to optimize biologics manufacturing. The successful candidate will act as a trusted technical expert, leveraging their bioprocess engineering background to build analytics solutions, drive process standardization, and partner closely with scientists and digital teams.

We are seeking candidates who fit the Domain-to-Data Professional profile:

A bioprocess, biochemical, or regulated manufacturing engineer who has developed meaningful data science expertise through hands-on work with process, analytical, and batch data. You must be able to apply tools such as Python, R, SQL, and statistical modeling to support process characterization, digital analytics, root-cause investigations, and regulatory-ready manufacturing data products.

Key Responsibilities

1. Biologics Process Analytics & Engineering Strategy

• Define and drive an advanced process analytics roadmap focused on connecting unit operations (upstream/downstream), process parameters (CPPs), and quality attributes (CQAs) through enterprise data models.

• Act as the vital bridge between bioprocessing science and data technology—translating complex manufacturing process dynamics into data requirements, and translating data capabilities into scientific and operational value (e.g., yield improvement, cycle time reduction).

• Lead process-focused data initiatives, assembling cross-functional teams (engineers, scientists, IT) to implement advanced analytics and digital capabilities across biologics manufacturing workflows.

2. Manufacturing Data Architecture & Contextualization

• Build and maintain a clear data flow map across the biologics manufacturing network, integrating core manufacturing systems (MES, LIMS, PI Historian, SAP, ELN).

• Lead process data contextualization and ontology mapping. Ensure raw process and analytical data is properly linked across unit operations, sites, and product lifecycle stages to enable seamless tech transfer and comparability studies.

• Partner with IT to co-design scalable, GxP-compliant data engineering solutions, providing the critical bioprocess domain context required to structure the data correctly for scientific use.

• Define and enforce data integrity specifications (ALCOA+) to ensure reliability and regulatory compliance across manufacturing data products.

3. Process Monitoring, Modeling & Statistical Enablement

• Develop and deploy fit-for-purpose dashboards, process visualizations, and analytics to enable Proactive Process Monitoring (PPM), trend identification, and rapid root-cause investigation support.

• Partner with the Statistical Sciences (CMS) and Process/Product Modeling teams to ensure the underlying data foundation robustly supports Continued Process Verification (CPV), digital twins, AI/ML models, and multivariate analysis.

• Collaborate with internal manufacturing sites and Contract Manufacturing Organizations (CMOs) to establish sustainable data access and improve the usability of process/analytical data for technical troubleshooting.

4. Process Governance & Standardization

• Establish process data standards, nomenclature, and data ownership models across the biologics network to enable cross-site comparability and AI readiness.

• Build data stewardship practices that are owned and sustained by the engineering and science teams, ensuring data governance is treated as a core manufacturing capability.

5. Stakeholder Engagement & Capability Building

• Drive alignment across Technical Product Managers, process SMEs, Quality, Regulatory Affairs, and IT to advance shared process-analytics priorities.

• Build digital and data literacy across Bio S&T by coaching peers, sharing engineering-focused use cases, and enabling governed self-service analytics through templates and training.

Education Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Life Sciences, or a related field with 8+ years of relevant biopharmaceutical experience.

• M.S. in the same fields with 6+ years of relevant experience, or Ph.D. with 4+ years of relevant experience.

Required Experience and Skills

Bioprocess Engineering & Domain Expertise

• Strong foundational knowledge of biologics manufacturing (Upstream/Downstream unit operations, scale-up, tech transfer) and process characterization.

• Proven experience utilizing process data (PI Historian, MES, LIMS) to troubleshoot manufacturing issues, monitor process performance, or support regulatory filings.

• Deep understanding of GMP/GxP environments, Continued Process Verification (CPV), and quality/compliance requirements in biomanufacturing.

Data Science & Technical Engineering

• Hands-on experience with Python or R for data manipulation, statistical analysis, and scripting—applied specifically to scientific or manufacturing datasets.

• Moderate to strong hands-on SQL skills; ability to query, transform, and validate data across relational databases.

• Understanding of how to extract and structure time-series data (e.g., from PI/DeltaV) and relational batch data to build actionable process models.

• Familiarity with data architecture concepts (data lakes, data warehousing) and experience collaborating with IT/Data Engineering to operationalize analytical pipelines.

Leadership, Strategy, and Communication

• Strategic thinking and independent execution capability — ability to define a data strategy roadmap and drive hands-on delivery against it without requiring a team to execute beneath you.

• Proven ability to influence without authority and drive alignment across technical,

• Strong change management skills — ability to drive adoption of new data practices and tools across a complex, globally distributed organization.

• Ability to translate complex technical and data concepts into clear, actionable recommendations for both technical and non-technical audiences.

• Comfortable operating in ambiguity and early-stage capability building — able to define the right approach before executing it.

• Track record of operating as a trusted technical expert and advisor within cross-functional teams — coaching and sharing knowledge without formal authority.

Preferred Experience and Skills

• Experience with biologics manufacturing data systems and the specific data challenges associated with bioprocess scale-up, tech transfer, and commercial manufacturing.

• Familiarity with data platform and mapping standards, OSIsoft PI / PI AF, Seeq, Power BI, Spotfire, Dataiku, JMP, AWS, Databricks.

• Background in PPM, CPV, investigation support analytics, cross-site process robustness analysis, or statistical process control in a GMP environment.

• Experience with external manufacturing data exchange — partnering with CMOs and external sites to establish governed data access and contextualization.

• Experience building or scaling a data function within a science or manufacturing organization — including hiring, developing, and organizing a team around a clear data strategy mission.

• Experience with master data management or semantic data models that support cross-system comparability and reuse.

• Track record of influencing senior leadership and cross-functional partners on data strategy priorities and investment decisions.

Why Join PDSM

This is a rare opportunity to build something foundational. PDSM is in the early stages of creating a truly integrated data and digital capability for biologics commercialization — and the Data Strategy function is at the center of that work. You will:

• Shape the data architecture and governance framework that underpins Bio S&T’s entire digital and analytics agenda.

• Work at the intersection of pharmaceutical manufacturing science and cutting-edge data and digital capabilities.

• Partner with a high-performing, mission-driven team across PDSM, Digital, IT, and the broader Bio S&T organization.

• Contribute directly to accelerating how transformative medicines reach patients — faster, smarter, and with greater scientific confidence.

• Ability to travel up to 10%.

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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