Research Associate II

Research Associate II

Baxter International

Marsa, Malta

As a Research Associate II, you will be knowledgeable in change control methodology, scientific principles and technical writing.

This position will work on IV base solutions and flexible filled container systems, planning, scheduling and leading studies of varying complexity and leading change controls, with guidance.

You will collaborate with global colleagues from other functional areas including Project Management, Stability, Sterility, Manufacturing, Regulatory, Material Science, Quality, and Packaging Engineering.

What you’ll be doing

• With some guidance, perform chemistry/engineering based assignments related to IV base solutions / primary drug container / delivery system design including authoring and updating documents.
• Apply science-based principles to determine the best solution(s) for technical issues. Ability to focus on critical information without getting bogged down in unnecessary details.
• Contribute to the program/project or the organization’s technical strategy.
• Leverage knowledge of technology, process, and/or therapy domains to drive solutions and product designs.
• Collaborate with manufacturing facilities to design and execute production of experimental units for testing.
• Manage change control associated with laboratory/manufacturing processes (test method assay updates, pharmacopoeia/API changes, container closure changes, etc.) as per project needs and agreed timeline; Participate in R&D studies through writing and review of protocols, experiments and reports.
• Occasional travel to Baxter sites internationally may be required. 0-10%.

Primary responsibilities

Self-motivated, resourceful, and flexible. A self-starter is imperative. Strong interpersonal communication skills and ability to communicate effectively with internal and external customers.

Effectively operate in and facilitate cross-functional teams with guidance. Technical writing proficiency to author internal reports and scientific papers. Have knowledge and understanding of GMP and related regulations and guidances. Able to communicate challenging messages with guidance. Good verbal and written communication skills. Ability to work collaboratively and influence others as part of a global, cross functional team across multiple disciplines. Familiarity with IEC, ICH, ISO, FDA and other regulatory standards and GMP/QSR environment. Utilizes current product knowledge to facilitate Change controls when required for product support post marked such as SNC, SCAR, complaint investigations or updates to the DHF and Technical documentation. Skilled at presentations within the technical community.

What you'll bring

• Education: Bachelors or Master's degree in Life Sciences (Chemistry/Biology/Pharmaceutics) or Engineering.
• Number of Years Experience 0-2 years.
• Background/knowledge in chemical solutions/drug development, knowledge of change control methodology.
• Able to work in a team environment and demonstrate an inclusive attitude. Ability to facilitate and influence cross-function global teams.
• Appropriately prioritize assignments to meet project schedules.
• Fluent in English.

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