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Analytical Scientist
Ref No.: 16-03124
Location: Fort Worth, Texas
Start Date / End Date: 12/19/2016 to 05/28/2017
The Senior Scientist will work within the Drug Product Development organization to lead formulation, drug product process development, and primary packaging development activities for therapeutic protein products in late stage development.
  • Design, execute, and interpret experiments to develop formulations, manufacturing processes, and primary container configurations (including combination products) for biologic products in late-stage development up to commercialization.
  • Based on above, summarize results in technical reports, presentations, and regulatory documents as needed.
  • Contribute to establishing best practices in the biologics formulation and drug product development laboratories.
  • Implement innovative technologies, including the use of high throughput approaches, to design robust formulations and manufacturing processes for biologic therapies.
  • Participate in drug product development teams responsible for the planning and execution of product development plans including formulation and drug product process development, technology transfer, scale-up, and validation activities, based on project goals and timelines.
  • Interface with cross-functional areas and CMC project teams to drive project milestones.
  • Maintain and enforce safe laboratory practices and environment.
  • Interact effectively with members of the Biologics Development department across the globe, and with other project stakeholders (Quality, Regulatory CMC, Technical Project Management, others).

Skills: Strong scientific background in protein formulation, drug product process development for liquid and lyophilized products, and biophysical characterization of proteins.
Demonstrated technical expertise in drug product formulation and manufacturing unit operations, including bulk storage, freeze/thawing, compounding, mixing, sterile filtration, filling, lyophilization, and primary packaging.
Demonstrated experience in Design of Experiments (DoE) and multivariate analysis modeling for experimental design and data analysis.
Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate
Education: Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with minimum of 3 yrs of relevant industrial experience in therapeutic protein formulation and drug product development.

Alternate: MS with 10+ years of relevant industrial experience.