Senior Scientist, Strategic Laboratory and Digital Operations

Merck & Co.•West Point, PA

34d•Hybrid

About The Position

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.

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.
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
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)

Nice To Haves

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

Responsibilities

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.

Benefits

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

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