Process Development Sr. Associate Scientist

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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Process Development Sr. Associate Scientist with experience in Pharmaceutical, Biotechnology or Medical devices industries to optimizes, and scales up laboratory processes to ensure efficient production of biologics and therapeutic products.

RESPONSIBILITIES:

• Conduct research into the structures and properties of materials, such as metals, polymers, and ceramics to obtain information that could be used to develop new products or enhance existing ones.
• Determine ways to strengthen or combine materials or develop new materials with new or specific properties for use in a variety of products and applications.
• Develop testing methods to evaluate the effects of various conditions on containers materials
• Plan laboratory experiments to confirm feasibility of processes and techniques used in the production of materials having special characteristics.
• Perform experiments, records, organize data and analyze results under minimal supervision.
• Generates robust and reliable data in compliance with the respective protocols, methods or SOPs.
• Identify container components defects and provide solutions related to possible technical problems of moderate scope and complexity.
• Perform Container Defects, Primary Packaging and Glass/Polymer Forensics Evaluations
• Study the nature, structure and physical properties of glass and polymer containers and their responses to applied forces.
• Test material samples for tolerance under tension, compression and shear, to determine the cause of failures.
• Test individual parts and products to ensure that manufacturer and governmental quality and safety standards are met.
• Evaluate and interpret results using imaging acquisition equipment’s.
• Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision.
• Operate specialized laboratory equipment and computers as appropriate.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Initiate and complete laboratory routine technical tasks.
• Complete complex or novel assignments requiring development of new and/or improved scientific/engineering techniques and procedures.
• Monitor and maintain inventory of supplies and sample inventory.
• Coordinate and review work with peers on an ongoing basis.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Must be independent, self-motivated, organized, able to multi-task in laboratory environments, and skilled in communication, facilitation, and collaboration.
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
• Apply knowledge of scientific/engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Generates robust and reliable data in compliance with the respective protocols or SOPs.
• Support commissioning and qualification activities.
• Share knowledge to develop the teammates in expertise discipline.

TASKS:

• Monitors field of expertise, including literature and technology development, and communicates relevant observations.
• Understands and interprets primary components specifications and methods.
• Demonstrates knowledge regarding metal, glass and polymer formation process and primary container components defects and classifications.
• Perform Primary Packaging Evaluations and Glass/Polymers Forensic Analysis.
• Introduce advanced scientific methods.
• Develops and implements news and novel protocols to address specific issues.
• Represent the department on project teams under supervision.
• Initiates productive collaborations within and outside of the Process Development Department and Network.
• Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
• Participates with the external scientific community.
• Assumes lead role in department-wide support efforts such as safety, OE and other committees.
• Develops and follows timelines for completing project teamwork.

• Educational background in Engineering and/or Sciences.
• Knowledge in Material Sciences (glass/polymers).
• Knowledge of the practical application of engineering, sciences, and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
• Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
• Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
• Knowledge and prediction of physical principles, laws, interrelationships, and applications to understanding fluid, material, and atmospheric dynamics, and mechanical, electrical, atomic and sub- atomic structures and processes.
• Understanding of equipment commissioning and qualification, validation and documentation processes in a highly regulated environment.
• Familiarity with Biopharmaceutical Environment.
• Knowledge in Primary Packaging Components (vials, syringes, cartridges, etc.)
• Knowledge in Secondary Packaging Components (labels, dispensing cartons, blisters, etc.).
• Knowledge in Glass/Polymer Forensics.
• Bilingual (Spanish/English).
• Computer literacy. 
   

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