MSAT SMDS Cleaning Science Fellow

Johnson & Johnson • Athens, GA

11d • Remote

About The Position

The MSAT Synthetic Drug Substance Fellow – Cleaning Sciences is a global, senior scientific leadership role within the MSAT Synthetic Drug Substance platform. This role strengthens platform-wide synthetic drug substance cleaning sciences capability across a complex, multi-product manufacturing network, supporting increasing compound potency, portfolio complexity, and global regulatory expectations. The Fellow serves as the global technical authority for synthetic drug substance cleaning sciences, providing scientific leadership, lifecycle stewardship, and external advocacy. The Fellow collaborates closely with internal & external manufacturing site cleaning sciences teams that execute cleaning lifecycle activities and cleaning validation.

Requirements

• 15+ years of experience in pharmaceutical manufacturing/MSAT/technical operations, with deep expertise in synthetic drug substance manufacturing operations and a strong understanding of interdependencies with cleaning science and validation.
• Demonstrated ability to set or govern global technical standards/strategies and influence decisions across sites without direct authority.
• Proven track record in supporting regulatory inspections and responding to complex technical questions related to cleaning and contamination control.
• Experience partnering cross-functionally (e.g., Quality, Engineering/GET, Toxicology, EHS) to deliver risk-based, compliant outcomes.

Nice To Haves

• External scientific engagement (e.g., publications, conferences, industry consortia/working groups) preferred.

Responsibilities

• Set global technical direction for synthetic drug substance cleaning sciences and resolve complex, high-impact issues.
• Provide expertise in cleaning chemistry and cross-contamination risk management to set science-based residue limits and controls.
• Steward science-based principles and technical positions for cleaning strategies across the global network to drive consistent, compliant decisions.
• Consult on novel, high-complexity, or precedent-setting scenarios (e.g., high-potency compounds, new chemical classes, complex equipment trains) to enable timely decisions and risk mitigation.
• Benchmark best practice in the sustainability aspects of cleaning.
• Steward global cleaning validation frameworks aligned with ICH guidelines to enable consistent, inspection-ready approaches.
• Apply lifecycle thinking across validation, continued verification, and re-validation to sustain control and drive continuous improvement.
• Set global, risk-based principles for worst-case selection, sampling approaches, and analytical strategy to enable standardized, science-based acceptance criteria across sites.
• Serve as the technical escalation point for complex cleaning-related changes, deviations, and investigations to ensure scientifically sound root-cause conclusions and effective CAPA.
• Drive proactive cleaning readiness with R&D cleaning experts, tech transfer, and sites across commercialization readiness and post-launch lifecycle to de-risk commercialization and subsequent changes.
• Embed cleaning criteria in tech transfer and lifecycle change assessments to enable right-first-time validation and sustained control at sites.
• Define cleaning maturity and compliance-risk criteria to inform supplier selection, and support the uplift of supplier capability in cleaning sciences, as needed.
• Partner with cross-functional stakeholders (R&D, Engineering, Quality, Impurity Management, Tox, EHS) to align cleaning strategy and accelerate adoption of proven and emerging cleaning technologies.
• Drive adoption of global synthetic drug substance cleaning technical positions and lessons learned across sites to standardize best practices and execution.
• Representing J&J in industry and scientific forums to shape external thinking and stay current on evolving expectations.
• Steer network-wide synthetic drug substance cleaning science capability priorities to strengthen technical decision quality.
• As a core member of Cleaning Sciences CoP (Community of Practice), provide technical governance for global guidance and learning assets to enable consistent application across sites.
• Enable technical peer review and knowledge sharing to accelerate learning and standardize best practices.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed