Drug Product Development (DPD) is a department in Biotherapeutics Development and Supply (BTDS). The department is responsible for formulation/process development and testing of therapeutic proteins or other biologics including monoclonal antibodies (mAbs), virus like substances, cell based therapeutics and mixed conjugates. The Lab Operations role will be responsible for the Quality, Compliance, Process Improvement, Resourcing and Laboratory Operations as it relates to financials.
Key General support to functional area’s such as:- Onboarding process
- Promote Continuous Improvement efforts and culture
- Purchase requests related to laboratory and contracting needs
- Capex execution and capital 5 year strategic planning
- General Laboratory operations including:
- Laboratory up-keep and maintenance
- Laboratory layout and design
- Laboratory process and efficiencies (POU, Inventory, Process Improvements)
- Managing external relationships for laboratory support (VWR, ELIS, LL, SBM)
- Manage facility and maintenance requests
- Value Stream coordination, follow up and oversight of Quality & Compliance for DPD labs
- Assist with onboarding of new equipment (utilities, WOs, identify SME, set up workstation)
- Functional planning reporting
- Process Improvement Initiatives and efforts
- Develop onboarding procedure for DPD new hires
- Provide business support to the DPDS Large Molecule Value Stream staff in several support area’s (e.g. System Based Compliance, Contracting, Work Orders, Facility and Maintenance Requests, strategic planning).
- Ensure continuous improvement using Process Excellence and Lean methodologies.
- Facilitate activities and processes for the functional staff and be influencing in process thinking and problem solving.
- Value Stream coordination, follow up and oversight of Quality & Compliance for DPD labs.
- Manage and report metrics to teams and management.
- Work in a multidisciplinary team of researchers, internally as well as externally.
Qualifications
Education: Bachelor’s degree in Business/Science/Engineering degree is preferred; a minor in a scientific field is a plus, advanced degree or MBA preferred.Experience and Skills:- Prior experience (3 - 8 years) with department budgets, capital requests, contract reviews, project management, clinical supply chain activities.
- Experience with MS Project and advanced capabilities of Excel is preferred.
- Significant experience leading Problem Solving and Process Improvement teams (Six sigma/Lean certification is a plus)
- Strong communication skills with the ability to interact with all levels throughout the organization.
- Must be able to work effectively in a fast-paced team environment to meet company objectives and commitments.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
Primary Location
United States-Pennsylvania-Malvern-335 Phoenixville Pike
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2206009484W