Description
responsibilities:
- Develop a process for the transfer of chemical components to Knoxville.
- Produce lab-scale mixes of transferred formulation
- Source and select materials compatible with product design, regulatory requirements, and process capabilities.
- Design and develop transferrable and scalable processes for existing production equipment.
- Design and execute experimental runs that characterize the interaction of input material variations with process parameters and the result on the output product.
- Deliver well-documented, dynamic design control for all products, meeting ISO 13485 and internal Scapa procedural requirements (e.g., PLM, Design Control, etc.).
- Execute with cGMP per 211 FDA guidelines for pharmaceutical practices
- Maintain compliance with relevant GMP, GLP, health and safety requirements
- Create and analytical test methods
- Perform analytical testing on samples using wet chemistry, physical characterization, and advanced instrumentation techniques, including Microscopy, FTIR, HPLC, GC-MS, pH, etc.
- Interpret the test data independently or with guidance to make sound technical evaluations for quickly resolving quality issues related to raw supplier issues, Manufacturing, and consumer complaints.
- Design and execute experiments under guidance to help improve the current testing procedures or develop new protocols.
- Routine testing of raw material, bulk batch, packaging, and stability samples.
- Authority to quarantine bulk or finished products if the need arises.
- Ability to communicate test results effectively
- Document all the results by following company policies and GLP practices
- When applicable, manage internal process improvement projects including but not limited to raw material qualification and production process improvements
qualifications:
Required
- BS degree in Science (Chemistry or Material Science) or
- Skilled in Minitab, project management software and proficient in Microsoft Office Suite
- Knowledge of SAP
- Experience with Laboratory Information Management systems preferred
- Up to 2 years' experience in Analytical Chemistry and application to problem resolution using analytical techniques and sound data interpretation preferred
- Experience in communicating with suppliers
- Pharmaceutical knowledge of FDA and GMP experience
- 5 years' experience in formulation development or scale-up > 3 years' experience in a manufacturing environment
- HPLC and wet chemistry lab experience in regulated Project management skills: setting and monitoring scope, actions and timelines, risk identification and mitigation
Preferred
- Experience in Design Control meeting ISO 13485 requirements
- Stability Knowledge
- Sterilization Knowledge (ETO, E-Beam, and Gamma Radiation)
- Skilled in Microsoft Office Suite
Competencies
Mativ and its subsidiaries are Equal Opportunity Employers. Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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