Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies Johnson & Johnson is recruiting for a Staff Scientist, Technical Operations Solids Platform to be located in Fort Washington, PA.
The Staff Scientist, Technical Operations Solids Platform will:
- Be responsible for technical support including formulation and process development activities, technology transfer, process performance qualification, continued process verification, and on-going life cycle management and optimization for solid oral products.
- Troubleshoot and solve complex technical issues that have substantial impact on product quality and business outcomes.
- Lead technical teams or be the technical lead on cross functional teams. Lead and coordinate project activities, resources, etc. Develop, manage, and execute project tasks per established timelines and be accountable for achievement of project milestones.
- Design, document, and execute or manage the execution of experimental plans (including sample collection, in-process testing, etc.).
- Analyze data, develop recommendations based on sound scientific rationale, and summarize conclusions in technical reports or memos. Also review and approve memos and technical reports from 3rd party providers.
- Write or approve SOP’s based on areas of expertise and training. Provide technical advice on SOP’s, policies, and procedures.
- Manage change control deliverables/documentation, investigations, CAPAs, and APR data collection, analysis and review/approval.
- Prepare and lead reviews of scientific data for assigned projects with Governance Teams.
- Provide direction and mentorship to Co-ops and entry level scientists.
- Maintain training proficiency on cGMPS, SOP’s, testing procedures, and data analysis as required
- Partner with cross-functional peer groups and management.
- Work under minimal supervision.
- Make decisions that have a direct impact on supply chain.
- Effectively influence people, execute multiple projects and tasks of with varying degrees of complexity.
- Review Regulatory documents and provide input as required for NDA and sNDA submissions.
- Perform other related duties as required.
- A Bachelor’s Degree in Engineering, Chemistry, Pharmacy or related technical discipline is required.
- An advanced technical degree is preferred.
- 6+ years of pharmaceutical manufacturing and/or process development related experience is required. Experience in solid dosage form scale-up, process/product technology transfer, and/or process validation is required.
- Applied knowledge of cGMPs, ICH, CFR is required.
- Experience trouble-shooting and optimizing commercial solid oral dose manufacturing processes is preferred.
- Experience in product formulation and/or product development is preferred.
- Proficiency in word processing programs (e.g. WORD), spreadsheet applications (e.g. EXCEL), and data based documentation systems (e.g. CONNECT, EDM, Documentum, TrackWise etc.) is preferred.
- Experience in conducting statistical analyses with familiarity in statistical software (e.g. Minitab, etc.) is preferred. Oral and written communication and presentation skills are required.
- Six Sigma training and/or certification is preferred.
- This position is based in Fort Washington, PA and may require up to 20% travel based on business needs.
United States-Pennsylvania-Fort WashingtonOrganization
J & J Consumer Inc. (6101)Job Function
Process EngineeringRequisition ID
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