The Sr 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 hydrophylized membrane surfaces that will be used in diagnostic assays. 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 Material Master and Quality Management expertise
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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