- Excellent employment opportunity for a Biologic Material Scientist or Technical Steward in the Frederick, MD area.
- Will work with the product raw material procurement and technical teams to define & assess requirements for raw materials and product contact materials.
- Ensure that the process materials meet established industry requirements, such as biopharmaceutical grade, adventitious agent controls, leachable & extractable, dual sourcing, etc.
- This effort requires interactions with multidisciplinary and multisite groups, which may include technology transfer teams, external vendors and other strategic suppliers.
- Evaluate the material attributes, structures and properties, such as composition, product compatibility, and comparability in order to obtain information to determine
whether materials are acceptable for GMP use
- Define/ recommend conditions for material use for reliable performance in various environments.
- Assess Certificate of Analysis and additional testing methods (if any) to confirm/ evaluate the effects when used as second sourcing options in various manufacturing
processes on particular the company products.
- If required by risk assessment, plan laboratory qualification experiments and/or material attribute assessments to confirm feasibility of processes and techniques
used in the production of materials having special characteristics.
- Prepare reports of materials study findings for the use of other scientists and requestors.
- Test material samples for further functional test capabilities, to further support feasibility for utilization.
- Therefore, work at the MS&T laboratories will be required; Contractor should be capable to train in lab procedures and specifically, cell culture processes and testing, to better understand what to consider in the material 2nd source.
- Assess material's supplier production processes to ensure that materials are manufactured to meet technical and quality specifications in order to be used
efficiently and that the project is completed within appropriate time frames and budget.
- When required, test individual parts and products in order to ensure that manufacturer and quality and safety standards are met.
- Stay abreast of the latest technologies used in Biologics with the awareness of the cost of various technologies
- Savvy in the utilization of change management and risk base assessment processes
- May participate in vendor interactions/visits of potential drug substance companies; equipment and material suppliers; and support due diligences
- Might provide technical support for product/process materials and investigations throughout product lifecycle
- Manages a cross-functional team or internationally in own field of specialism.
- B.S. in Engineering, Biological/Physical Sciences, or equivalent focus of study with 5 years of experience, or M.S with 3 years of experience facility.
- Someone who can bridge the gap between the teams using the raw biologic materials and the vendors selling the company materials.
- Someone who can collaborate with partners within the regulatory affairs department to ensure company remains compliant.
- Strong documentation experience with quality assurance but has a laboratory background specifically with cell culture processes and testing.
- Full use and application of principles, theories, concepts and techniques in a limited area or field.
- Able to work on multiple projects and meet deadlines as needed
- Demonstrate good oral and written skills.
- Experience with GMP manufacturing at a biologics or pharmaceutical manufacturing facility.
- The resource must establish relationships with Validation, Engineering, Development, CMOs, Supply Chain, Quality, Regulatory and others in Operations
- Experience with GMP manufacturing at a Biologics or Pharmaceutical Manufacturing