Posted in Other 30+ days ago.
Location: Cincinnati, Ohio
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
Work Location: Cincinnati, OH (on-site)
How will you make an impact
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 with minor level of supervision. Investigates, crafts, and validates new scientific methodologies for a diverse scope of projects. Using experimental design, establish formulation and processes for the following phases of development: toxicology, pre-clinical - phase III, scale-up, registration. Leads technical/scientific project activities and discussions to implement strategies and technical solutions that meet customer needs and expectations. Develops processes for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Leads problem solving activities with independent judgement. Makes decisions that require choosing between multiple options or may develop new options to resolve problems. Serves as a technical lead and mentors other scientists. Communicates to supervisors, and project team peers (analytical, quality, and project management) on the progress of activities.
What will you do
Performs all duties in strict compliance with SOPs, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintains the compliance status required by company and facility standards.
Drives the design, evaluation and development of formulations for pre-clinical studies, clinical trials, process development, and scale-up as defined by client requirements.
Mentors junior level scientist and/or technologist to increase their knowledge base while supporting one's own career progression.
Actively participates/lead problem solving for assigned projects. For example, lead organization of individuals required for a detailed evaluation and investigation of incidents which occur on the manufacturing floor.
Drafts 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).
Leads product development with minor amount of supervision.
Reviews and plans all technical aspects of the project which includes planning and prioritization of multiple projects or task to meet the appropriate timelines.
Understanding of the selection of the individual excipients and the dosage form to support clinical purpose. Ability to reverse engineer products.
Ability to craft experiments to conduct investigations that find the true root cause. Ability to formulate statistics in support data or findings.
Review quotes, protocols, results, and reports for all client projects.
Ensures the collection and interpretation of process data, as well as, a detailed scientific review in order to substantiate the conclusions/recommendations in reports.
Recommends and assists in implementing team/company and technical improvements crafted to improve the efficiency, reliability, and productivity of operations all conforming to applicable regulatory standards.
Help develop realistic proposals and timelines. Participates in and leads relevant meetings/teleconferences with clients.
Develops methods and processes that meet or exceed the expectations from clients and provides innovation.
Researches industry practices and processes and applies to innovative development internally and for client products.
How will you get here
Education / Experience
Bachelor of Science in science or engineering field.
Typically requires 6+ years of scientific experience.
Equivalent combinations of education, training, and meaningful work experience may be considered.
Deep knowledge of multifaceted aspects or a specialized aspect of a field.
Good knowledge of scientific methodology as related to the pharmaceutical industry.
Knowledge of Good Manufacturing Practices.
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Excellent critical and logical thinking skills.
Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.
Knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
Physical Requirements / Work Environment
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
This position has not been approved for relocation assistance.
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