Lead impactful material science initiatives in pharmaceutical manufacturing. Collaborate with cross-functional teams in a dynamic, fast-paced environment. Enhance technical expertise in regulated industries and GMP practices.
Materials Specialist
in Healthcare + Life Sciences ContractJob Detail
Job Description
Overview
- Contribute to the onboarding and lifecycle management of single-use materials in pharmaceutical manufacturing processes.
- Collaborate with cross-functional teams in a dynamic and fast-paced environment.
- Develop technical documents and risk assessments adhering to GMP documentation practices.
- Coordinate testing activities with external laboratories and suppliers, ensuring project timelines are met.
- Review supplier documentation and material certifications for qualification purposes.
- Perform extractables and leachables risk assessments using established tools and templates.
- Support material-related change controls, investigations, and impact assessments.
- Maintain effective communication with stakeholders regarding project progress and outcomes.
Key Responsibilities & Duties
- Support qualification of single-use manufacturing components such as bags, tubing, filters, and connectors.
- Conduct material assessments and risk evaluations for manufacturing materials.
- Review and summarize analytical reports for technical assessments and qualification packages.
- Develop testing recommendations and requirements for material qualification activities.
- Coordinate and track testing activities with external laboratories and suppliers.
- Author and maintain technical documents, reports, and qualification records.
- Collaborate with teams across MSAT, Process Development, Manufacturing, and Quality Assurance.
- Ensure adherence to GMP documentation practices in all activities.
Job Requirements
- Bachelor's or Master's degree in Materials Science, Chemistry, Chemical Engineering, or related field.
- 3–6 years of experience in biotechnology, pharmaceutical, or regulated industries.
- Proficiency in single-use systems and extractables/leachables assessments.
- Strong technical writing and attention to detail.
- Ability to collaborate effectively across multiple functions.
- Experience with material-related change controls and investigations.
- Knowledge of GMP documentation practices.
- Capability to manage project timelines and communicate progress effectively.
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