Lead Formulation Scientist

2 weeks ago

Cranbury, New Jersey, United States J-STAR Research Full time
Company Overview:

J-Star Research, Inc. operates as a Contract Development and Manufacturing Organization (CDMO) specializing in the advancement and optimization of drug substances and products. Our comprehensive solutions cater to the development of new drug candidates, guiding them from the discovery phase through to preclinical and Phase I clinical studies.


Position Summary:

The primary responsibility of this role is to conduct preformulation studies, formulation and process development, optimization, scale-up, and manufacturing in alignment with J-Star's drug product development initiatives.

The successful candidate will leverage their expertise in drug product formulation and manufacturing process development to create prototypes of dosage forms derived from new chemical entities.

In particular, this role encompasses the formulation and manufacturing process design for solid, liquid, and semi-solid dosage forms intended for new drug candidates throughout preclinical and early clinical stages.

Applicants must possess legal authorization to work in the US.


Key Responsibilities:
  • Execute formulation development and optimization studies for various dosage forms, including solid, semi-solid, and liquid forms, utilizing Quality by Design (QbD) principles.
  • Oversee process optimization and scale-up activities, ensuring effective technology transfer to manufacturing sites.
  • Present experimental objectives and results, defining the design space to senior management and cross-functional teams, as well as to clients.
  • Maintain meticulous documentation of all laboratory data, preparing and reviewing protocols, master batch records, development reports, CMC regulatory documents, and Standard Operating Procedures (SOPs).
  • Contribute to the maintenance of a high-quality laboratory environment, adhering to Health, Safety, and Environmental responsibilities.
  • Perform additional tasks as necessary to fulfill company objectives.

Basic Qualifications:

Advanced degree in Pharmaceutics, Chemical Engineering, or related fields, with a Ph.D. and no experience or a Master’s degree with a minimum of 5 years of industry experience.

Extensive background in preformulation studies, formulation design, and process development, with a solid grasp of physical chemistry, pharmaceutics, and biopharmaceutics principles.

Familiarity with cutting-edge technologies for developing diverse dosage forms and drug delivery systems, including solid oral dosage forms, semi-solids, liquids, and suspensions.

  • Practical experience in oral drug product manufacturing unit operations, including blending, granulation, milling, spray drying, fluid bed granulation, drying, coating, tableting, film-coating, and encapsulation.

Hands-on experience in pharmaceutical analysis, with knowledge of method development and instrumentation used in preformulation and formulation studies.

A comprehensive understanding of cGMP, regulatory, and safety standards.

Self-motivated, organized, and proactive in problem-solving, with the ability to work independently and manage multiple projects effectively while meeting deadlines.

Excellent interpersonal, written, and verbal communication skills.


Preferred Qualifications:

Ph.D. in Pharmaceutics, Chemical Engineering, or related disciplines.

Prior experience in product development for preclinical and First-in-Human (FIH) studies.

Experience in analytical method development is advantageous.

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