Johnson & Johnson Careers
Principal Scientist, Processing Lead
Fort Washington, Pennsylvania; Fort Washington, Pennsylvania
Requisition ID: 00001ETA
The Johnson & Johnson Consumer family of companies is currently hiring for a Principal Scientist, Processing Lead to be located in Fort Washington, PA or any Consumer site in North America.
Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.
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.
The position is responsible for technical leadership, including formulation and process development activities, characterization, confirmation, process performance qualification, and continued process verification associated with Technology Transfer projects, and on-going process optimization for commercialized products. This role will serve as the processing lead for multiple, simultaneous Technology Transfer projects.
Project Frazier is focused on optimizing manufacturing capabilities and options. The duration of this position is dependent on the overall execution timeline for the project. Anticipated need is 24 - 36 months, with potential adjustments to accommodate Project Frazier business needs.
• Designs, manages and executes project task per established timeline. Accountable for achievement of project milestones.
• Prepares or approves technical memos, reports, analyzes and summarizes data, and recommends conclusions based on scientific rationale. Reviews and approves reports and confirms conclusions are based on scientific rationale.
• Designs methods to efficiently carry out planned experimentation.
• Execute requirements of the planned experimental design (i.e. sample collection, in-process testing, sample management, etc.).
• Manages, troubleshoots, and make recommendations based on the results of the planned experimentation and investigations.
• Prepares and leads reviews of scientific data for assigned projects at governance.
• May provide direction and mentorship to junior colleagues, contractors and Co-ops.
• Manage change control deliverables/documentation, investigations, CAPAs, and APR data collection, analysis and review/approval.
• May review and approve Commissioning and Qualification documentation such as plans, protocols and reports as required.
• Provides technical advice on SOP’s, policies, and procedures. May serve as SOP author or approver based on area of experience and training.
• Maintains training proficiency on cGMPS, SOP’s, testing procedures, and data analysis as required.
• Conducts interdependent partnering and collaboration with cross-functional peer group and management.
• Works under minimal supervision.
• Decisions made at this level may have direct impact on supply chain.
• Performs other related duties as required.
• Leads a technical team or primary technical lead on cross functional teams. Ability to lead and coordinate project activities, resources, etc.
• Effectively influence people, multiple projects and tasks of various complexities.
• Review Regulatory documents and provide input as required for NDA's and sNDA submissions.
• Solves difficult and complex technical issues that have substantial impact on on the product quality and business outcomes.
• A minimum of a Bachelor’s degree is required; with a science degree (or equivalent) in Engineering, Chemistry, Pharmacy or related technical discipline preferred.
• A minimum of 8 years of related experience is required.
• Experience in Drug Manufacturing GMPs or a related industry is required.
• Experience in Drug Formula and Process design is required.
• Experience in Drug Product Tech Transfer, Remediation and Validation is required.
• Experience with regulatory agency inspections (e.g. FDA, MHRA, etc.) is preferred.
• Strong working knowledge and proven results in an external environment is preferred.
• The interest in scientific topics with the ability to speak with non-scientists and understand technical requirements is highly preferred.
• Proven ability to influence/collaborate required.
• This role is located in Fort Washington, PA, or any Consumer site in North America, and may require up to 30% of travel both domestically and internationally.
United States-Pennsylvania-Fort Washington-
North America, United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)