Research Analyst II

Bill: $54.80
Pay: $39-36
Spread:
229.3-376.1
Duration:2 years

Contractor – Research Analyst II - Global Material and Parenteral Packaging Sciences

We are seeking a skilled Scientist to join our Global Material and Parenteral Packaging Science team, a core component of Product Development Science & Technology (PDS&T). The candidate will help drive the development of Container Closure Systems (CCS) for Client parenteral and biotechnological products (NBEs), supporting the advancement of some of Client's most strategic pipeline assets, including monoclonal antibodies, antibody-drug conjugates, and therapeutic toxins.

In this role, you will leverage your expertise in characterizing CCS encompassing vials, prefilled syringes, and prefilled cartridges with a strong focus on Container Closure Integrity (CCI) and process capability. Your responsibilities will include conducting performance analyses using force analyzers, developing and validating analytical methods, providing technical support for CCS and process qualification in pharmaceutical manufacturing, and evaluating and implementing cutting‑edge techniques.

• Preparation, execution and evaluation of experiments for development of container closure systems of new parenteral drug products, namely drug preparations of biotechnological drugs in vials, pre-filled syringes and cartridges as well as lyophilisates.
• Technical evaluation and implementation of CCI and process methods as well as continuous improvement based on a holistic CCI strategy and current regulatory requirements.
• Responsibility for maintaining lab equipment. Ensure required maintenance schedule, proper documentation, and training.
• Technical support of the landscaping programs for innovative CCS, including implementation and characterization based on various CCI techniques.
• Collaborations with Client partner labs and/or external labs and manufacturing sites.
• Coordination of suppliers for materials, equipment, and services needed to perform work.
• Documentation of all work according to applicable GxP and internal procedural requirements.
• Authoring comprehensive, scientifically sound reports, e.g. lab reports, development reports or risk assessments that could serve as source documents for authority submissions.
• Compliance with all relevant work safety requirements.

• Degree from an accredited University in pharmacy/biology/biotechnology/chemistry/process engineering/material sciences/physics or related areas.
• Bachelor's Degree or equivalent education with typically 2 or more years of experience, or Master's Degree.
• Good technical and scientific understanding of parenteral drug product development and CCI test methods.
• Understanding of relevant scientific literature and ability to apply theoretical framework to solving problems within their scientific discipline in a timely manner.
• Ability to work concurrently on multiple projects, work in teams, and manage priority conflicts.
• Good verbal and written communication skills.
• Ability to establish comprehensive scientific and project related documentation.
• Strong motivation and proactive approach to lab responsibilities.

OPST - Operations Product Development Science & Technology (OPST)

6003|CC|PDS&T - Ana-LC (R&D) (636564)