R&D/Mfg Scientist III

Work Schedule

Environmental Conditions

Job Description

COMPANY: Thermo Fisher Scientific Inc.

LOCATION: 2110 E. Galbraith Road, Cincinnati, OH 45237

TITLE: R&D/Mfg Scientist III

HOURS: Monday to Friday, 8:00 am to 5:00 pm

DUTIES: Lead and/or perform activities for the development of new formulations and manufacturing processes of solids, liquids, and semi-solid dosage forms by selecting excipients, equipment, and processes.
Investigate, craft, and validate new scientific methodologies for a diverse scope of projects.
Use experimental design to establish formulation and processes for the following phases of development: toxicology, pre-clinical phase III, scale-up, registration, and validation.
Lead technical/scientific project activities and discussions to implement strategies and technical solutions that meet customer needs and expectations.
Develop processes for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients.
Serve as a technical lead and mentor other scientists.
Communicate to supervisors, and project team peers (analytical, quality, and project management) on the progress of activities.
Perform all duties in strict compliance with SOPs, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
Maintain the compliance status required by company and facility standards.
Drive the design, evaluation and development of formulations for pre-clinical studies, clinical trials, process development, and process validation to be commercialized as defined by client requirements.
Represent the organization on formal technical and scientific forums such as AAPS, webinars, and CRS.
Actively participate/lead problem solving for assigned projects such as lead organization of individuals required for a detailed evaluation and investigation of incidents which occur on the manufacturing floor.
Draft quality batch production records, reports and protocols as needed or to support client regulatory submission to a regulatory agency such as the United States Food & Drug Administration (FDA). Maintain current knowledge of FDA requirements related to oral dosage form development.
Lead product development.
Lead the review and planning of all technical aspects of the project which includes planning and prioritization of multiple projects or task to meet the appropriate timelines.
Understand the selection of the individual excipients and the dosage form to support clinical purpose. Reverse engineer products.
Integrate risk-based approach during the development process and have the appropriate response to the mitigation strategy.
Craft experiments to conduct investigations that find the true root cause.
Formulate statistics in support data or findings.
Review quotes, protocols, results, and reports for all client projects.
Participate in training, qualification of equipment, and writing Standard Operating Procedures (SOPs). Ensure the collection and interpretation of process data, as well as, a detailed scientific review in order to substantiate the conclusions/recommendations in reports.
Recommend and assist in implementing team/company and technical improvements crafted to improve the efficiency, reliability, and productivity of operations all conforming to applicable regulatory standards.
Participate in and lead relevant meetings/teleconferences with clients.
Develop methods and processes that meet or exceed the expectations from clients and provides innovation.
Research industry practices and processes and applies to innovative development internally and for client products.
Liaise with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
Travel: Up to 5% travel required (domestic only).

REQUIREMENTS: MINIMUM Education Requirement: Masters degree in Pharmaceutics, Engineering, or related field of study. MINIMUM Experience Requirement: 4 years of experience in positions in which the required experience can be gained, or related positions. Alternative Education and Experience Requirement: Bachelors degree in Pharmaceutics, Engineering, or related field of study plus 6 years of experience in positions in which the required experience can be gained, or related positions. Required knowledge or experience with: Scientific methodology as related to the pharmaceutical industry; Good Manufacturing Practices; Microsoft Office Suite (Word, Excel, and PowerPoint); Leading technical discussions with internal and external clients; Working on multiple highly technical projects simultaneously; Pharmaceutical processes, equipment, instrumentation, and procedures; and Developing technical solutions.