MSD

Executive Director, Bio S&T Platform, Data, Statistics & Modeling

MSD

full-time

Posted on:

Location Type: Hybrid

Location: New Jersey • Pennsylvania • United States

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Salary

💰 $231,900 - $365,000 per year

Job Level

Lead

About the role

  • Develop and co-own with Digital Manufacturing a multi-year digital and data strategy for biologics late-stage pipeline and inline aligned with enterprise priorities; translate strategy into a prioritized execution roadmap with clear business cases and ROI metrics., and drive execution against that roadmap.
  • Establish approach and drive acceleration of adoption of analytics, statistics, modeling, AI/ML and structured content practices in Bio S&T, while holding functions accountable for execution.
  • This role will also be responsible for integrating across the Bio S&T functions in driving a robust knowledge management and document management strategy for CMC filings.
  • This will be done in close integration and collaboration with Digital Manufacturing and Digital CMC.
  • This role will oversee the integrated data architecture and governance model within Bio S&T that unifies process data across upstream/downstream, scale-up/tech transfer and commercial operations, including external CMOs/CDMOs.
  • Serve as Bio S&T functional owner for key lab/process systems across Bio S&T (e.g ELN, utilization of VTN, KX etc); drive adoption and enable cross program learnings.
  • Coordinate and sustain maintenance of process platforms and standards across Bio S&T functions, with functions holding content accountability.
  • Identify needs, develop biologics tech business strategy for mechanistic/statistical modeling, predictive analytics, digital twins, and support NLP-enabled data extraction driving Bio S&T level execution of Digital CMC strategies, ensuring sustainability and efficiency.
  • Drive strong collaboration with Digital Manufacturing to link business and data science & analytics capabilities in Digital Manufacturing.
  • Define, track and report KPIs for data quality, model impact, process performance (yield, cycle time, first-pass success), submission timelines and cost savings, while driving execution through Bio S&T functions.
  • Drive operationalization of analytics into workflows (experimental design, tech transfer, manufacturing control, lot release) and partner with continuous improvement teams to capture efficiencies.
  • Integrate at site technology process data leads and above site process data leads driving to efficient and sustainable execution of overarching biologics data strategy and process monitoring.
  • Oversee and streamline statistics support & training across Manufacturing process and analytical working groups, and functions.
  • This role will partner very closely with Digital Manufacturing and Digital CMC to drive an integrated strategy for biologics across Bio S&T functions.
  • This team will integrate existing local efforts on data management, data strategy, modeling, statistics, data sciences within Bio S&T.
  • Drive change and adoption of data and digital mindset within Bio S&T across all functions and all levels of the organization.
  • Recruit, develop and retain a multidisciplinary team; champion inclusive talent management and succession planning.

Requirements

  • 10+ years industry experience in biologics process development, manufacturing, CMC or related functions, with substantial experience leading enterprise digital/data transformation.
  • Demonstrated experience building COEs or comparable cross-functional organizations, implementing enterprise data strategies and integrating external manufacturing data.
  • Strong domain knowledge of biologics upstream/downstream processes, PAT, analytical workflows, tech transfer and regulatory expectations.
  • Technical fluency with data architectures and ability to interface with IT and Digital CMC.
  • Proven track record delivering measurable cost and process improvements from digital initiatives; strong financial acumen for business case development.
  • Exceptional leadership, communication and stakeholder management skills; success operating in matrixed environments and partnering with Quality/Regulatory teams.
  • Ability to work through influence, action orientation and drive change.
Benefits
  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data strategyanalyticsstatisticsmodelingAI/MLmechanistic modelingpredictive analyticsdigital twinsNLP-enabled data extractiondata architecture
Soft Skills
leadershipcommunicationstakeholder managementinfluenceaction orientationchange managementcollaborationteam developmentinclusive talent managementsuccession planning