Jobs · Analyst · North Carolina

Scientist, Formulations

Alcami Corporation · Morrisville, NC · 1 wk ago
AnalystFull-time

Responsibilities

  • Creates formulation development plans and executes well-designed experiments to define the qualitative and quantitative formulation composition.
  • Conducts design of experiments (DoE) studies to identify and investigate key and critical quality attributes to confirm formulation robustness as per ICH Q8.
  • Writes and executes protocols to prepare formulations for testing and characterization, methods development and technology transfer.
  • Records and reports study results in compliance with good scientific policy and procedures.
  • Evaluates new scientific technologies/equipment to enhance capability, capacity, and efficiency.
  • Reports and presents scientific/technical results internally and to external clients.
  • Utilizes complex tools/equipment, lab automation tools, and specialized facilities.
  • Maintains and operates equipment according to safety standards and operating procedures.
  • Reviews own work and conduct peer review.
  • Participates in scientific conferences and contributes to scientific journals.
  • Provides coaching and mentoring to junior colleagues and newcomers.
  • Ensures timely completion and compliance with SOPs and all other relevant company training requirements.

Qualifications

  • Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or equivalent with 6-8 years of experience or Master’s degree with 2+ years of experience.
  • Strong customer service focus and excellent customer contact skills.
  • Thorough fundamental knowledge and understanding of solubility and stability theory and practice.
  • A solid understanding of drug solubilization and stabilization techniques in liquid dosage forms.
  • Hands on expertise in aseptic techniques for liquid formulation, compounding, and manufacturing.
  • Experience in aseptic filtration, terminal sterilization and lyophilization process techniques.
  • Knowledge of raw material selection strategy and criteria for parenteral and liquid dosage forms.
  • Basic understanding of physical characterization tools such as DSC, particle size and different viscometers.
  • Hands-on experience in analytical techniques such as UV-Vis and HPLC.
  • Basic understanding of quality attributes and regulatory requirements for parenteral and liquid dosage forms.
  • Basic understanding of quality attributes for biologics formulations.
  • Knowledge of methods for characterization and testing of liquid and parenteral dosage forms.
  • Ability to plan and manage multiple tasks for timely achievement of results.
  • Ability to efficiently organize work with little or no supervision.

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