Description

Job Description

Vaccine Drug Substance Commercialization (VDSC) is seeking a highly motivated person for the role of R3 Senior Scientist, Strategic Laboratory and Digital Operations. VDSC is imbedded within our company Manufacturing Division and focuses on late-stage process development, technology transfer, and in-line support of vaccine products. This unique role ensures that our lab equipment and automation systems are running safely and effectively while also overseeing the business tools and systems to efficiently deliver our portfolio of work.

We seek people-oriented leaders with strong business systems acumen and organizational skills to take a leadership role in the development of business standardization to improve productivity and efficiency. The R3 candidate within VDSC will partner with groups across the company, including Technical Operations, Operations, Quality, Biologics and Drug Product Commercialization, Process Development, Facilities, Environmental Health and Safety (EHS), Global Engineering Solutions (GES) and Finance.

Our Engineers and/or Scientists support internal and external manufacturing operations to remain efficient, continuously improve, and innovate. With our extensive range of facilities/laboratories and environments, there are opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

In this role, you will be responsible for:

• Working independently and as a team member with integrity, precision, accomplishment, respect and inclusion.
• Build transformational capabilities for the centralization and standardization of lean business practices and systems.
• Develop tools, templates, and schedules as necessary for recurring tasks to improve team productivity, inclusive of data governance dashboards, data connector pathways, Key Process Indicator (KPI) matrices, etc.
• Visual Factory digital tier administrator for VDSC, Community of Practice stakeholder
• Develop, build and sustain the current Commercialization (SIGNALS) experiment management platform including:
• Attend and lead data governance workstreams
• Provide feedback on platform updates / upgrades
• Perform User Acceptance Testing (UAT) for standard data flow templates to ensure fit for purpose for universal adoption
• Communicate and cascade updates to all user groups
• Review, update, and approve procedural guidance updates for the platform
• Partner with the internal Automation and Commissioning teams to provide laboratory execution insight into data flow management and retention requirements.
• Act as Vaccine Science and Technology portfolio management steward using Power Applications to drive synergy across the project management portfolio.
• Maintain the partnership with Digital to support the Lab Modernization Accelerate plan to drive standardization, harmonization and innovation initiatives.
• Lead development and execution plan for laboratory start up, including equipment ordering, planning for testing, maintenance, calibration, commissioning and qualification.
• Support capital project execution teams for lab renovation projects to ensure project scope alignment with intended lab operational philosophy and lab scale platform requirements.
• Develop tools and schedules to aid process teams in the efficient utilization of lab space and shared assets.
• Provide guidance on GXP quality continuum requirements and departmental systems focusing on equipment documentation and traceability to identify and implement initiatives to improve the VDSC compliance posture.
• Provide mentorship and technical direction to other members of the team which may include dotted-line reporting relationships.
• Creating written policies/procedures for continuous improvement using logical problem-solving methodologies.
• Define and implement standard work.
• Make risk-based technical decisions to define, initiate, and sustain transformational initiatives.

Position Qualifications

Education Requirements

• B.S. in Chemical engineering, Biochemical Engineering, Bioengineering, Computer Sciences, Biology, Microbiology, or related field with six years of relevant experience.
• Master's degree in related areas with four years of relevant experience.

Experience and Skills

Required

• Laboratory start-up environments, operations, or management experience
• Large Molecule manufacturing or laboratory management
• Strategic project management, planning and implementation
• Trouble shooting and problem-solving methodologies
• Outstanding communication and people skills
• Ability to foster a collaborative work environment focused on mentorship and coaching
• Digital data steward experience
• Understanding and familiarity with data-based Automation control systems

Preferred

• Familiarity with GMP/GXP environments and associated compliance expectations for commissioning protocols
• Development of training systems and onboarding guides
• Training in Lean/Six Sigma in a lab context
• Familiar with our company MPS Tier business processes for communication/escalation
• Knowledgeable in Drug Substance or Drug Product, end to end process development
• Ability to provide technical mentorship and guidance to coworkers and colleagues within and outside of the organization
• Familiarity with Python coding practices
• Familiarity with Delta V automation code
• Familiarity with Digital Connected Instruments middleware/ software platforms (SDC, Lab X, MEDCON, Open Lab, EMPOWER, UNICORN, etc.)
• Strong intrinsic problem-solving skills, ability to structure and solve problems independently and escalate for concurrence
• Ability to work independently as well as working in teams

Required Skills:
Accountability, Biodesign, Biological Sciences, Bioreactors, Capital Projects, cGMP Regulations, Chemical Engineering, Detail-Oriented, Environment Health and Safety, Good Manufacturing Practices (GMP), Innovation, Machine Learning (ML), Microbiological Cultures, Process Design, Process Optimization, Process Scale Up, Production Process Development, Productivity Improvements, Strategic Management, Strategic Planning, Teamwork, Technology Transfer, User Acceptance Testing (UAT)

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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.

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$114,700.00 - $180,500.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
some chemical hazards in adjacent labs

Job Posting End Date:
01/1/2026
*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.

Requisition ID:R375891