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Drug Product Tech Transfer Lead, Biologics
Johnson & Johnson. Ensure fit for plant and commercial readiness during technical development .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in technical transfer of biopharmaceutical products, ensuring compliance with GMP requirements and optimizing new product introduction processes. Proven ability to manage site-level support for drug product manufacturing and integrate supply chain technical expertise into project execution.
Highest-signal resume keywords
Technical Transfer Of Biopharmaceutical ProductsGMP Requirements KnowledgeDrug Product Manufacturing SupportProject Management CertificationDocument Management Systems Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmaceutical Product R&DDP Unit OperationsNew Product Introduction ProcessQuality By Design ImplementationCost Of Goods Optimization
Soft Skills
Team Efficiency FosteringCollaborative Work Through Matrix TeamsInfluencing Without AuthorityProblem-Solving SkillsMotivated Self-Starter
Tools & Technologies
RIMdocsTruVaultSAPMS Office ApplicationsCometPlanisware
Certifications & Qualifications
FPX CertificationPMP Certification
Industry Keywords
Pharmaceutical ManufacturingSupply Chain IntegrationRegulatory DocumentsTechnical SupportProcess Robustness
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Ensure fit for plant and commercial readiness during technical development
- Implement new innovations and technologies
- Execute transfer of pharmaceutical processes and products into the supply chain and global marketplace
- Manage site-to-site transfers using the Best Process/Product at Launch mindset
- Provide drug product technical support and oversight for supply chain
- Plan and execute drug product manufacturing site-level support for new product launches
- Integrate new and re-developed drug products from R&D into the supply chain
- Contribute to, review, and approve drug product technical and regulatory documents
- Provide routine technical support and integrate supply chain technical expertise into project execution
- Implement Quality by Design technical activities at manufacturing sites
- Act as single point of contact for plant readiness, execution, and launch support
- Identify and implement opportunities to decrease Cost of Goods and improve process robustness and commercialization
- Develop manufacturing site execution plans and ensure strategy alignment
- Coordinate product introduction from transfer through launch, including raw materials, formula, process, packaging, and device integration
- Optimize the New Product Introduction process and streamline technical transfers
Requirements
What you’ll need- Minimum of a Bachelor's or equivalent degree (required)
- Minimum 6 years of relevant work experience with pharmaceutical product R&D and/or Manufacturing / MSAT functions, or equivalent (required)
- Experience with technical transfer of biopharmaceutical products into manufacturing sites, including technical knowledge of DP unit operations (required)
- Knowledge of manufacturing site systems and procedures, including an understanding of GMP requirements (required)
- Proficient in English (required)
- Up to 20% domestic and international travel, depending on project needs (required)
- Ability to foster team efficiency and cohesiveness and work collaboratively through matrix teams
- Ability to influence with or without direct authority
- Motivated self-starter able to work independently
- Proven problem-solving skills
- Knowledge of DP late-stage development (preferred)
- Experience with document management systems such as RIMdocs, TruVault, SAP, MS Office applications, Comet, and/or Planisware (preferred)
- FPX, PMP, or equivalent Project Management certification (preferred)
Benefits
Comp & perks- Inclusive work environment
- Continuous professional development opportunities
- Business improvement opportunities
- Up to 20% domestic and international travel