The Scientist will be located in Mishawaka, Indiana as a member of the Organic Chemistry Group (OCG). The position is in a Manufacturing group that is responsible for producing reagents and components for multiple diagnostic assays. This position will be primarily responsible for the preparation of derivatized nano-particles. However, the preparation of other reagents in the OCG portfolio is always an option. The work will be conducted in a ‘Regulated’ environment.
Duties and Responsibilities:
- Accurately and neatly records information while following established written protocols
- Works as a member of a team to perform a variety of chemical techniques used to prepare intermediates used in further production
- Preparation of solutions, auditing instruments, control charting, procedure reviews, and providing support for general laboratory activities
- Must have knowledge of good laboratory practices in a cGMP environment, with strong analytical capabilities
- Must function well under extreme pressure and be able to meet daily commitments and deadlines while continuing to make appropriate decisions regarding product quality
- Must be able to follow procedures under minimal supervision, be confident in his/her ability to make / defend decisions and/or seek guidance when appropriate.
- Needs to be flexible and be able to handle ever changing priorities while demonstrating attention to detail, and good technical judgment
30% Research (Process Development/Process Optimization)
- Must be able to conduct process optimization using statistical methods.
o Design DOE protocol(s)
o Execute DOE Protocol(s)
o Evaluate the Data from DOE(s).
- Create new Work Instructions for assigned project(s).
- Conduct validation of process improvements or new product development
- Strong computer skills
- Ability to work as part of a team
- Must be detail oriented and highly organized
- Must be able to communicate effectively with external and internal customers
- Must recognize the underlying basis for regulations and rules and act in accordance
- Proficient in time management, possess well developed interpersonal skills, demonstrate strong written and verbal communication skills, and exhibit attention to detail
Required Knowledge/Skills, Education, and Experience:
- Master of Science degree (Chemistry, Biochemistry, or Chemical Engineering) with a minimum of 3 years of large scale/preparative organic laboratory experience preferred
- A Bachelor of Science or comparable educational background with a minimum of 6 years of experience will be considered if the individual also has strong experience in industrial chemical process development.
- Industrial experience and knowledge of GMP/ISO preferred.
- SAP experience not required but most helpful.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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