GLOBAL HEAD, TECH TRANSFER ATSC MSAT

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POSITION SUMMARY.
Johnson and Johnson Innovative Medicines is recruiting for the Advanced Therapies Manufacturing Science and Technology (MSAT) organization! We are working to create a world without disease.
Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science.
Are you interested in joining a team that is positively impacting patients' lives by growing and scaling our high quality cell and gene therapy products? Apply today for this exciting opportunity to be part of the team! The Head, Validation has overall accountability for ensuring continuous process verification/validation for the Advanced Therapies Supply Network.
By leading a team of Technical Launch Integrators and championing various communities of practice across the advanced therapies network, this role has the opportunity to influence across the Advanced Therapies network and drive process simplification, standardization, and improvement, as well as shape the regulatory landscape for advanced therapies with sound, leading science.
This role partners closely with Manufacturing, Quality, R&D, Value Chain, and Regulatory to ensure processes meet the needs of today and tomorrow.
ESSENTIAL FUNCTIONS.
· Accountable for the advanced therapies platform strategies for validation best practices and deploying across network.
· Develop and establish advanced therapies validation framework including risk-based strategies for the process validation of commercial manufacturing processes and ensure appropriate and robust application of these requirements throughout the product lifecycle.
These strategies include continuous process verification and control and the associated enabling documents (i.
.
validation or supporting technical studies).
· Lead a team of technical launch integrators responsible for the right-first-time technology transfer and capacity scaling of pipeline and commercial products to CMOs, internal manufacturing sites including new facility construction and start-up.
Co-create standard best practice documentation and lean, effective ways of working consistent with industry and regulatory standards · Design and lead execution of risk assessments and validation studies that are compliant with company’s validation program and aligned with industry’s regulatory best practices.
· Champion validation perspectives in deviations/investigations, corrective and preventative action and change controls across network of advanced therapies manufacturing operations.
· As needed, review/author relevant technical sections of regulatory dossier or other communications to health authorities, as well as, provide leadership in support of inspections/audits.
· Benchmark externally to maintain understanding of rapidly changing regulatory environment and influence internally & externally to shape regulatory environment.
· Drive validation best-practices and continuous improvement to enable cost-effective capacity scaling The compensation range for this role is.
$ Qualifications · University/Bachelors Degree in Science/Engineering or Equivalent with Years Biotech/ Pharmaceutical experience or Masters/PhD degree in Engineering, with 10+ years Biotech/ Pharmaceutical experience or equivalent industry experience · Hands-on experience in Manufacturing Operations and/or R&D in a biopharmaceutical manufacturing setting (ie.
cell/gene therapy products, vaccines, or any other advanced therapy products) · Experience leading technology transfer activities and technical services for cell/gene therapies · Excellent technical skills and problem-solving skills · Knowledgeable in manufacturing sciences, cGMP compliance, change management methodology and advanced therapies product regulatory and validation requirements · Knowledge of data analytics/statistics and process automation · Ability to lead and influence multidisciplinary, cross-functional teams in an international environment Project-dependent travel 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.