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

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. It will report to Vice President, Biologics Science & Technology (S&T), and sit on the Bio S&T leadership team.

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. 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.

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).

Required Skills

Biopharmaceutical Operations, Biopharmaceutical Operations, Biopharmaceutics, Bioproducts, Biostatistics, Business Case Development, Business Strategies, Change Agility, Chemical Engineering Fundamentals, Computational Biology, Consulting, Data Analytics, Data Governance, Data Strategies, Digital Manufacturing, Financial Acumen, Leadership, Leadership Development Training, Manufacturing Scale-Up, Organizational Design, People Analytics, People Leadership, Planning, Product Lifecycle, Project Controls Management {+ 2 more}

Preferred Skills

Current Employees apply HERE

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Requirements

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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Employee Status: Regular

Relocation

Relocation: Domestic

VISA Sponsorship

VISA Sponsorship: No

Travel Requirements

Travel Requirements: 50%

Flexible Work Arrangements

Flexible Work Arrangements: Hybrid

Shift

Shift: Not Indicated

Valid Driving License

Valid Driving License: No

Hazardous Material(s)

Hazardous Material(s): n/a

Job Posting End Date

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R

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