Director, Digital Tech Transfer & Knowledge Management

Caraway Therapeutics, Inc.; United States; Hybrid; USD 173.000 - 273.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. leads in biopharmaceutical manufacturing, applying digital tech transfer and PKM to connect data across MES, LIMS, and process controls.

The role shapes the product strategy, mentors a team of analysts, and ensures compliant, scalable digital solutions that support a global manufacturing network. You will partner with S&T, Research, Commercialization, and IT to translate complex needs into actionable programs, aligning with regulatory standards and business goals while driving

Qualifikationen

• Bachelor's degree and 10+ years in industry.
• Proven track record in pharmaceutical tech transfer and readiness.
• Experience delivering large-scale, data-intensive digital products.
• Strong leadership of technical and cross-functional teams.
• Excellent communication with senior leaders and experts.
• Deep knowledge of biopharma manufacturing data, controls, and systems.

Aufgaben

• Define and champion the product vision and strategic roadmap for Digital Tech Transfer and PKM.
• Lead and mentor product analysts and specialists, fostering innovation and execution excellence.
• Oversee lifecycle of digital manufacturing products from concept to deployment and improvement.
• Translate business needs to scalable, compliant digital solutions across functions.
• Drive data integration across MES, LIMS, and control systems for PKM ecosystem.
• Ensure data integrity, governance, and regulatory compliance (GxP).
• Manage product backlog and prioritise features based on value and strategy.
• Collaborate with CMOs to digitise tech transfer and data exchanges.

Kenntnisse

Product Management

Leadership

Stakeholder Management

Agile methodologies

Communication

Cross-functional teams

Data governance

Ausbildung

Bachelor's degree in Engineering, CS, Life Sciences

Tools

MES

DeltaV

PKM

Databricks

SCADA

PI

Jobbeschreibung

Job Description

Our company is at the forefront of the biopharmaceutical industry, using digital technology to transform manufacturing. Our strategic team manages process knowledge and data across the product lifecycle—from commercialization and technology transfer through ongoing commercial supply. We deliver integrated digital solutions that make critical process information accurate, accessible, and actionable, enabling smarter, faster, and compliant manufacturing across our global network.

Responsibilities

• Define and champion the product vision and strategic roadmap for Digital Tech Transfer and Process Knowledge Management (PKM), ensuring alignment with overarching business goals.
• Lead and mentor a high-performing team of product analysts, technology and process specialists, fostering a culture of innovation and execution excellence.
• Oversee the entire lifecycle of digital manufacturing products that support tech transfer, from initial concept and requirement gathering to deployment and continuous improvement.
• Serve as the primary liaison between Science & Technology (S&T), Research, Commercialization and manufacturing operations, and IT to translate complex business needs into scalable and compliant digital solutions.
• Drive the strategy for integrating disparate data sources (e.g., MES, LIMS, process control systems) to create a cohesive process knowledge ecosystem for seamless technology transfer.
• Champion the principles of data integrity and governance to ensure all process data is reliable, accurate, and inspection ready.
• Manage the product backlog, prioritize features based on business value and strategic importance, and communicate progress to executive stakeholders.
• Ensure all digital solutions adhere to industry regulations, including GxP, and internal quality standards.
• Partner with external contract manufacturing organisations (CMOs) to digitise technology transfer and establish secure, standardised, and compliant ongoing process data exchanges.

Qualifications

Required

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field with a minimum of ten (10) years of required industry experience.
• Proven track record of supporting pharmaceutical technology transfer and establishing receiving-site readiness, including process knowledge transfer, capability assessment, data preparedness, and operational handover.
• Demonstrated experience in a product management, program leadership, or strategic role delivering large-scale, data-intensive digital products.
• Strong leadership capabilities with experience managing and developing technical and cross-functional teams.
• Exceptional communication and stakeholder management skills, with the ability to influence and align senior leaders and technical experts.
• Deep knowledge of biopharmaceutical manufacturing processes, technology transfer, and their associated data and control systems (e.g., MES, DeltaV, PKM, Databricks, SCADA, PI).
• Proven ability to connect high-level business objectives to detailed technical execution plans.
• Proven capability in implementing and scaling AI solutions in mission-critical, highly regulated environments, with appropriate governance, reliability, security, and compliance controls.

• Direct experience implementing or managing Process Knowledge Management (PKM) systems and digital tech transfer solutions.
• Familiarity with advanced analytics, machine learning, and their applications within a manufacturing environment.
• Experience with Agile development methodologies and a mindset geared towards digital innovation.
• Strong background in process analytics (PPA/PPM) and navigating GMP/GxP compliance requirements for digital systems.

Required Skills

• Asset Management
• Benefits Management
• Management System Development
• Product Management
• Requirements Management
• Stakeholder Relationship Management
• Strategic Planning
• System Designs

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - Pennsylvania - West Point

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:
$173,200.00 - $272,600.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 41(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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

Search Firm Representatives Please Read Carefully

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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:

11/4/2026
*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.