Scientist, Formulation and Process Development

  • Waltham, MA, USA
  • Full-time

Company Description

Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two lead product candidates. The product candidates are INVELTYSTM(KPI-121 1%) for the treatment of inflammation and pain following ocular surgery, for which we have submitted a NDA, and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease, which is currently in Phase 3 clinical development.

 

Job Description

Kala is an emerging pharmaceutical company on the verge of commercialization. We are seeking a highly motivated Scientist to join our Formulation and Process Development team.  This is an opportunity for the right individual to come onboard and be a part of a growing and dynamic R&D organization.

Key Responsibilities for this role will include:

  • Design novel nanoparticle-based pharmaceutical formulations and execute systematic studies to evaluate and optimize formulation performance and stability (chemical and physical);

  • Design and execute process development studies, including small scale process prototyping and Design of Experiments (DoE) studies to identify and optimize critical process parameters;

  • Support manufacturing process scale-up and process transfer to contract manufacturing facilities;

  • Collaborate cross-functionally:

    • Collaborate with Analytical scientists on designing and executing laboratory stability studies, support day-to-day characterization activities;

    • Work with the Chemistry team to evaluate formulation feasibility for novel therapeutic agents

    • Provide support to the Manufacturing team in matters relating to formulation behavior and process optimization / trouble-shooting

  • Author technical reports (formulation and process development)

  • Contribute to intellectual property, regulatory filings, and scientific publications.

Qualifications

  • PhD degree in Chemical Engineering, Materials Science, Physical Chemistry, or a related field

  • 0-3 years of experience as a formulation scientist or process development engineer

  • Strong problem-solving skills and analytical abilities

  • High degree of scientific curiosity, self-motivation, and ability to work in a fast-paced research environment

  • Strong technical/scientific writing skills

  • Experience with small molecule drug delivery is highly preferred (micro- and nanoparticle-based formulations, drug-eluding inserts, sustained release injectable formulations)

  • Experience with nanocrystals and nanosuspensions is highly preferred

  • Experience with particle size characterization methods (DLS, Laser diffraction) is a plus

  • Experience with analytical methods (HPLC, GC-MS) is a plus

  • Solid state form characterization skills (DSC, TGA, XRD) is a plus

  • Formulation / process development experience with ophthalmic (or sterile) drug products is a plus

  • Experience with statistical Design of Experiments is a plus.

Additional Information

All your information will be kept confidential according to EEO guidelines.