Principal Scientist, Product & Process Technology

Responsible for development, scale-up and tech transfer of new Oral Solid and Oral Liquid products to the Hobart site, and other sites as needed, from internal R&D and from external Pharma companies as a CMO service. In addition, the Principal Scientist, Product & Process Technology will use problem-solving techniques to resolve process difficulties, reduce waste, improve productivity and safety, and assist in training. The Principal Scientist will also provide technical support to site operations, maintenance, and manufacturing personnel for supported processes. Additional job duties include investigating new technologies and their application to manufacturing processes and assisting in development of products and processes for contract manufacturing projects.

Technical Transfer of Acquired / CMO Products – Technical Transfer of R&D Products are Managed and Supported

• Responsible for meeting KPI’s in supply agreement contracts with Pharma companies.
• Responsible for meeting all Tech Transfer project milestones within Hobart site control.
• Develop, write and review protocols and reports for the following batches: Product Characterization, Tech Transfer, Exhibit/Registration, and Validation.
• Complete statistical analysis of data. Develop/write product manufacturing instructions.
• Initiate and execute action items as required for OOS, Change controls, CAPA’s, FMEA’s.
• Support new process start-ups including equipment and process development.
• Use knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale-up projects.
• Manage development activities to ensure projects meet the development schedule requirements.
• Knowledge of DOE, statistical techniques for data analysis, total quality management, Six Sigma in manufacturing.
• Strong communication skills are required to manage projects effectively. This includes the ability to direct and motivate personnel who are not in the same department or function.

Technical Aspects of Legacy Products are Managed and Supported

• Use problem solving techniques to resolve manufacturing issues, reduce cost, waste and improve quality with existing processes.
• Responsible for meeting all Tech Transfer project milestones within Hobart site control.
• Develop, write and review protocols and reports for the following batches: Product Characterization, Tech Transfer, Exhibit/Registration, and Validation.
• Complete statistical analysis of data.
• Develop/write product manufacturing instructions.
• Develop/write/execute development protocols for existing products and new product transfers.
• Initiate and execute action items as required for OOS, Change controls, CAPA’s, FMEA’s.
• Provide technical leadership in support of productivity improvement and cost reduction projects.
• Review all process changes to improve products for operation, reliability, efficiency and safety.
• Primary resource for resolving technical process issues.
• Support productivity improvements through process upgrades.

Key Competencies

• Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.

• Influencing Others: Moves people toward willing involvement in a particular course of action using techniques that appeal to logic, values or emotion; presents arguments that address others’ most important concerns and issues and looks for win-win solutions; involves others in a process or decision to ensure their support; identifies and proposes solutions that benefit all parties involved in a situation; accurately anticipates the implications of events or decisions for various stakeholders in the organization and plans accordingly.

• Innovation: Looks for new and creative ways of doing things; challenges current systems and procedures to identify break-through opportunities; looks for more than one solution; identifies correlations and relationships to solve multiple problems with one solution; applies original thinking in approach to job responsibilities and to improve processes, methods, systems, or services.

• Directing Others: Is good at establishing clear directions; sets stretching objectives; distributes the workload appropriately; lays out work in a well-planned dialogue with others on work and results; brings out the best in people; is a clear communicator.

• Driving Execution: Sets and maintains high performance standards for self and others that support the organization’s strategic plan and holds self and other team members accountable for achieving results; ensures organizational systems, processes and people are aligned to support strategic objectives; regularly evaluates self and team on goal attainment, processes used to achieve goals, and competitive benchmarks.

Minimum Requirements

Education / Experience / Skills:

Education required/ preferred:

• Ph.D. in Pharmaceutics or Industrial Pharmacy with 5 years Industrial Experience in Tech Transfer and Tech Services of Oral Solids and Oral Liquids; or MS in Pharmaceutics, Industrial Pharmacy, Engineering or Chemistry with 10 years Industrial Experience in Tech Transfer and Tech Services of Oral Solids and Oral Liquids.

Preferred Skills/Qualifications:

• Demonstrated ability to troubleshoot pharmaceutical operating equipment and support equipment used for the manufacture of oral solids and oral liquids.
• Pharmaceutical Formulation, scale-up, tech transfer, tech services and process validation experience with oral solid and oral liquid dosage formulations.
• Experience in OOS investigations, change controls, CAPA’s and FMEA’s.

Skills/Competencies:

• Black Belt (Six Sigma), Lean or similar skills preferred.
• This job requires strong written and verbal communication to include technical communication skills, to accurately convey technical issues and information.
• Understanding of solid and liquid pharmaceutical formulations and hands on experience in the manufacture of pharmaceutical products.
• Strong technical and mathematical aptitude.
• Strong computer literacy—MS office products, statistical analysis (Minitab) and database usage.
• Proven ability to lead multi-disciplinary, complex, and time-sensitive projects that could impact the business.
• Superior troubleshooting / problem solving skills.

Other Skills:

• Ability to manage multiple projects simultaneously.
• Must effectively manage conflict and exhibit managerial courage.
• Excellent communication skills and the ability to train, mentor, and develop others is essential.
• Must have the ability to influence without authority, solve problems and have a high degree of adaptability.
• Leadership, collaboration and decision making

Organizational Relationship/Scope:

• This position requires interaction with various internal and external department heads, Site Leadership Team, and all domestic and foreign pharmaceuticals facilities
• This position reports to the Manager Product Development and directly supports multiple teams.

Working Conditions:

Work will be performed in the office areas, production floor and relevant laboratories as well as the R&D headquarters site. Potential exposure to noise, dust, chemicals, and equipment. There may also be potential opportunities for travel.