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.
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies is recruiting for a Staff Scientist, Solids, to be based in Lancaster, PA.
The Staff Scientist, Solids will:
- Be responsible for technical support, 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.
- Design, manage, and execute project task per established timeline. Accountable for achievement of project milestones.
- Prepare or approve technical memos, reports, analyzes and summarizes data, and recommends conclusions based on scientific rationale. Review and approve reports and confirms conclusions are based on scientific rationale.
- Write or approve SOP’s based on area of experience and training. Provides technical advice on SOP’s, policies, and procedures.
- Design methods to efficiently carry out planned experimentation.
- Execute requirements of the planned experimental design (i.e. sample collection, in-process testing, sample management, etc.)
- Manage, troubleshoot, and make recommendations based on the results of the planned experimentation and investigations.
- Manage change control deliverables/documentation, investigations, CAPAs, and APR data collection, analysis and review/approval.
- Review and approve Commissioning and Qualification documentation such as plans, protocols and reports as required.
- Prepare and lead reviews of scientific data for assigned projects at governance.
- May 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.
- Conduct interdependent partnering with cross-functional peer group and management.
- Work under minimal supervision.
- Decisions made at this level may have direct impact on supply chain.
- 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 the product quality and business outcomes.
- Performs other related duties as required.
- A Bachelor’s of Science degree in Engineering, Chemistry, Pharmacy or related technical discipline is required.
- Six-plus years of pharmaceutical manufacturing related experience is required.
- Experience in process validation and process/product transfer is required.
- Knowledge of GMPs, ICH, CFR is required.
- Knowledge in technical transfer, product development and/or process validations are preferred. Proficient in cGMPs, word processing programs (e.g. WORD), spreadsheet applications (e.g. EXCEL), and data based documentation systems (e.g. CONNECT, EDM, etc.) is preferred.
- Knowledge in statistical analysis with familiarity in statistical software (e.g. Minitab, etc.) is preferred.
- Oral and written communication and presentation skills are required.
- Leadership experience is preferred.
- Experience with CAPA and/or investigations is required.
- Experience with solid dosage form is required.
- This position is based in Lancaster, PA and may require up to 10% travel based on business needs.
J & J Consumer Inc. (6101)Job Function