Scientist, Formulations

Alcami Corporation•Morrisville, NC

24d•Onsite

About The Position

The Scientist - Formulations is accountable for driving results in a fast-paced environment and leading formulation development studies for the design and identification of safe, stable, robust and manufactural pharmaceutical dosage forms. The Scientist - Formulations independently designs, plans, performs, interprets and reports results of scientific experiments for the preparation and timely delivery of drug products (DP), processes and procedures needed for technology transfer and manufacture of the product. The position requires superior leadership behaviors as well as expertise in functional competencies including scientific principles, laboratory practices, cGMPs and regulatory requirements for pharmaceuticals and biologicals.

Requirements

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.

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.
Other duties as assigned.