Job Description

TS/MS Materials - Associate

Location: Concord, NC

Duration: 4-6 months contract with possibility of extension or to be hired on as a permanent employee

Responsibilities:

Primary responsibilities of the position include understanding and ownership of the control strategy as it relates to materials and components. The Material and Component Scientist is responsible for providing technical support in order to achieve the reliable and compliant manufacture of parenteral drug product. The scope of the role includes syringe filling, device assembly, and packaging operations for commercially manufactured products targeted for transfer to the Concord site. While this role is not expected to be the technical expert on all products and platforms, it is expected to be the expert in regulatory, internal, and other requirements. A key part of this role is ensuring that there is consistency in approach / processes, up through and including regulatory submission.

Key Objectives/Deliverables:

• Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, product contact materials, and container closure systems.
• Act as a site subject matter expert and provide deep scientific and technical expertise for high risk materials (including primary/critical secondary packaging components), raw materials, and GMP consumables used in the drug product manufacturing process.
• Understand, justify, and document the state of qualification of components with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Establish and maintain technical documents and specifications for materials and components.
• Establish critical attributes for high-risk materials and execute studies as needed to define the limits of these parameters.
• Create, maintain, and perform applicable periodic review of materials and consumables.
• Evaluate the impact of changes at suppliers to the product/process.
• Lead/support technical projects to improve process control, capacity, quality, yield, and attribute measurement as related to materials and components.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
• Develop and implement a technical agenda with regard to materials used in the manufacture of parenteral products.
• Participate in troubleshooting and driving continuous improvement as it relates to materials and components.
• Provide technical support for all start-up activities (e.g. tech transfer, process validation).
• Provide technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and container closure integrity.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
• Provide manufacturing input on regulatory submissions and other pertinent regulatory topics related to product contact materials and container closure.
• Support risk management activities as it pertains to materials and components.
• Serve as technical interface external to the Concord site.
• Provide audit support, as needed.
• Collaborate with partners across the Parenteral Network.
• Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities.

Basic Qualifications:

• BS or MS in Material Science/Engineering, Biochemistry, Chemistry, Pharmacy, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Experience with data trending and analysis

Additional Skills/Preferences:

• Ability to analyze complex data and solve problems
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Knowledge of parenteral drug product manufacturing
• Experience supporting cGMP manufacturing (specifically within process development, technical services/MSAT, quality assurance, quality control etc.)
• Knowledge of container closure systems
• Understands compendial and international standards requirements
• Demonstrated successful leadership of cross-functional teams

Additional Information:

• Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and /or off-hour work may be required.
• This job description is intended to provide a general overview of the job requirements at the time it was prepared.
• The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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