Job Description
Immediate need for a Job title Biologic Material Scientist or Technical Steward experience in the Pharmaceutical Industry. This is 6+ Months Contract position for the location Frederick, MD. Please review the job description below:
Job ID # 21-03031
Experience with GMP manufacturing at a biologics or pharmaceutical manufacturing facility.
Someone who can bridge the gap between the teams using the raw biologic materials and the vendors selling AZ the materials.
Someone who can collaborate with partners within the regulatory affairs department to ensure AZ remains compliant.
Strong documentation experience with quality assurance, but has a laboratory background specifically with cell culture processes and testing.
An energetic, self-motivated and innovative individual who possesses skills required to successfully develop and execute project tasks and deliverables, be a collaborative team player and have a strong drive to deliver to customers.
Overview of Role:
This resource will work with the product raw material procurement and
technical teams to define & assess requirements for raw materials and product contact
materials. It is the responsibility of this resource to 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.
REQUIREMENTS
Minimum Education:
o B.S. in Engineering, Biological/Physical Sciences, or equivalent
focus of study with 5 years' experience, or
o M.S with 3 years' experience
Experience Required:
o Full use and application of principles, theories, concepts and
techniques in a limited area or field.
o Able to work on multiple projects and meet deadlines as needed
o Demonstrate good oral and written skills.
o Experience with GMP manufacturing at a biologics or
pharmaceutical manufacturing facility.
o The resource must establish relationships with Validation, Engineering, Development, CMOs, Supply Chain, Quality, Regulatory and others in Operations
Job Responsibilities & Accountabilities:
• 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 AZ 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
• Conduct activities and interactions consistent with Company values and in
compliance with the Code of Conduct and supporting Policies and Standards
relevant to your role. Complete all required training on the AZ Code of Conduct and
supporting Policies and Standards on time. Report potential issues of noncompliance.
• Manages a cross-functional team or internationally in own field of specialism. Role
requires a high level of interactive communication to set clear direction for the cross
functional team and directly advising others at a high level, as well as cultural
sensitivity. Manages high level risk by making complex judgements, developing
innovative solutions and applying a comprehensive cross-functional and industry
understanding.
Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration.
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