Staff Scientist, Solids
Location:
Lancaster , Pennsylvania
Posted:
January 20, 2017
Reference:
8019160531-en-us

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.

Qualifications
  • 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.
 

Primary Location
United States-Pennsylvania-Lancaster
Organization
J & J Consumer Inc. (6101)
Job Function
Process Engineering

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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