Technologies; Thermo Fisher Scientific). Ohio, Cincinnati

Work Schedule

Standard (Mon-Fri)

Office, some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

As a Manufacturing Scientist II, you will lead and/or implement activities for the development of new and established wouldn't. Project management skills will be applied to implement the scaling up manufacturing processes, supporting new product validations and post‑approval qualification activities. This will require writing, approving, and routing documents within a manufacturing setting.

You will be the primary technical representative on client projects and will work closely with internal and external teams of analytical, quality, and project management representatives. Supporting process development and commercial activities will be required. Leads technical/scientific project activities and discussions to develop strategies and solutions that meet client needs and expectations.

Investigates, creates, and validates new scientific and equipment methodologies for a diverse range of projects. Uses experimental design, established formulation processes for the following phases of product scale‑up, registration, and validation.

Creates processes and equipment designs for clinical, scale‑up, and/or registration batches, including technology transfer of projects to and from clients. Leads problem tuyệtaaradda as necessary with independent judgement, making decisions that involve multiple options or develop new solutions to resolve moderately complex problems.

• Time‑bound outlines to complete activities for the validation of new products and manufacturing processes of solids, liquids, and semi‑solid dosage forms.
• Leverage current leadership skills to provide support, mentoring, and guidance to internal team members and clients for product and process development activities performed in commercial manufacturing areas.
• Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations.
• Own the为什么 review and planning of all technical aspects of the project, which includes prioritization of multiple projects or tasks to meet the appropriate timeline achievements.
• Integrate a risk‑based approach during the scale‑up and commercialization of processes ylabel and develop appropriate mitigation strategies.
• Draft quality batch production records, protocols, and reports to support product development, validation activities, and routine commercial batches.
• Support routine manufacturing operations to assure timely release of products with appropriate quality attributes and steward commercial products of responsibility.
• Lead with project leadership skills required for daily meetings.
• Work independently within the Technical Services Department and as a team member within the department.
• Managing work independently with standard work planning and abilities to meet timelines established for projects.
• Proficiencies in Leadership, Trust, Diversity, and Focused behaviors are required for the position.
• Quality attitude to be exemplified daily with standard work.
• Outstanding team dynamics and idea generation are promoted.

Bachelor's degree in chemical engineering (or other engineering field), chemistry, pharmacy, or another related science or technical field is required.

• Minimum of one (1) to three (3) years of experience in a manufacturing environment preferred.
• Experience in product or process development, including scale‑up and technology transfer processes for both immediate and controlled release dosage forms preferred.
• Project Management experience preferred.

• Understanding of Good Manufacturing Practices (GMP) and regulatory compliance.
• Lead projects of moderate to high complexity in scope and compliance‑related challenges to implement processes that meet changing regulations.
• Proficiency using Microsoft (MS) Office applications.
• Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external…