Executive Director, Bio S&T Platform, Data, Statistics & Modeling
Merck, Rahway, NJ, United States
Job Description
We are seeking an experienced senior leader to define and execute enterprise biologics process focused strategy for process platform & process data analytics, statistics, modeling and data management across the full product lifecycle (transition from R&D to commercial) for internally and externally developed & produced biologics. The Executive Director will establish and lead a team of process experts partnering across the other Biologics S'T functions, Digital Manufacturing, Digital CMC, R&D Biologics DS & DP development and Global Biologics Operations, and deliver on the process data strategy for biologics for driving setting up process information flows through pipeline into inline, advanced analytics, predictive modeling/digital twins, Electronic Lab Notebooks, Knowledge Management, and robust data governance. This role will also lead statistics support for our Manufacturing Division and will report to Vice President, Biologics Science & Technology (S&T).
Key Responsibilities
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. Integrate across the Bio S'T functions to drive a robust knowledge management and document management strategy for CMC filings.
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, VTN, KX); drive adoption and enable cross‑program learnings.
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.
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.
Oversee and streamline statistics support & training across Manufacturing process and analytical working groups.
Partner closely with Digital Manufacturing and Digital CMC to drive an integrated strategy for biologics across Bio S'T functions.
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.
Education
Bachelor's degree (PhD preferred) in biochemical/chemical engineering, computational biology, biostatistics, data science or related field.
Required Experience And Skills
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.
Travel
Hybrid US‑based role with regular onsite engagement.
Travel typically 25–40% (subject to program needs).
Benefits Salary range: $231,900.00 – $365,000.00. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits package includes medical, dental, vision, retirement (401(k)), paid holidays, vacation and compassionate/sick days.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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Key Responsibilities
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. Integrate across the Bio S'T functions to drive a robust knowledge management and document management strategy for CMC filings.
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, VTN, KX); drive adoption and enable cross‑program learnings.
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.
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.
Oversee and streamline statistics support & training across Manufacturing process and analytical working groups.
Partner closely with Digital Manufacturing and Digital CMC to drive an integrated strategy for biologics across Bio S'T functions.
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.
Education
Bachelor's degree (PhD preferred) in biochemical/chemical engineering, computational biology, biostatistics, data science or related field.
Required Experience And Skills
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.
Travel
Hybrid US‑based role with regular onsite engagement.
Travel typically 25–40% (subject to program needs).
Benefits Salary range: $231,900.00 – $365,000.00. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits package includes medical, dental, vision, retirement (401(k)), paid holidays, vacation and compassionate/sick days.
EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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