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.