Process Development Associate

Collabera; Thousand Oaks (CA); Presencial; USD 34.000 - 36.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability insurance

Short-term disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Paid vacation time

Paid parental leave

Paid holidays annually

any additional benefits applicable

Descripción de la vacante

Collabera is seeking a Process Development Associate at our Thousand Oaks, CA headquarters. You will join the Pre-Pivotal Drug Product Technologies organization and work on oral solid dosage form development for early-stage clinical studies.

You will execute formulation experiments, support digital platform initiatives, and document results for cross-functional teams in a GMP/SOP-driven environment.

Formación

• Hands-on formulation laboratory experience in oral solid dosage form development.
• Experience with unit operations such as granulation, blending, tablet compression, and film coating.
• Experience with material characterization techniques such as DSC and XRPD; solid dosage form characterization (friability, disintegration, dissolution, density, flowability).
• Understanding of solubility enabling formulations, including amorphous solid dispersions (ASDs) and lipid-based formulations.
• Ability to independently execute experiments, analyze data, document results, and communicate findings to cross-functional stakeholders.

Responsabilidades

• Execute small molecule formulation experiments to support development of oral solid dosage forms for early-stage clinical studies.
• Contribute to creation and optimization of digital platform capabilities while supporting experimental efforts to design and optimize drug product formulations and processes.
• Communicate findings clearly to technical and cross-functional stakeholders.

Descripción del empleo

• Seeking an enthusiastic, motivated, and team-oriented Process Development Associate at our Thousand Oaks, CA headquarters to join the Pre-Pivotal Drug Product Technologies organization.


• In this role, you will be a key member of the Oral and Enabling Delivery Systems group within the Drug Product Technologies (DPT) department.


• The successful candidate will be responsible for executing small molecule formulation experiments to support the development of oral solid dosage forms for early-stage clinical studies.


• Additionally, you will contribute to the creation and optimization of digital platform capabilities while supporting experimental efforts to design and optimize drug product formulations and processes for pre-clinical and clinical solid oral dosage forms.


• The ideal candidate has hands-on formulation laboratory experience in oral solid dosage form development, including common unit operations such as granulation, blending, tablet compression, and film coating. Experience with material characterization techniques such as DSC, XRPD, as well as solid dosage form characterization, including friability, disintegration, dissolution, density, and flowability, is highly desirable. Understanding of solubility enabling formulations, particularly amorphous solid dispersions (ASDs) and lipid-based formulations, is an additional advantage. The candidate should be able to independently execute experiments, analyze formulation and process data, accurately document results and observations, and clearly communicate findings to technical and cross-functional stakeholders.


• The ideal candidate is proactive, adaptable, organized, and scientifically curious, with a strong desire to learn. They are comfortable working in a GMP/SOP-driven environment and can effectively balance hands-on experimental work with digital and analytical responsibilities.

Ideal vs. Average Candidate

• The ideal candidate has hands-on formulation laboratory experience in oral solid dosage form development, including common unit operations such as granulation, blending, tablet compression, and film coating. Experience with material characterization techniques such as DSC, XRPD, as well as solid dosage form characterization, including friability, disintegration, dissolution, density, and flowability, is highly desirable. Understanding of solubility enabling formulations, particularly amorphous solid dispersions (ASDs) and lipid-based formulations, is an additional advantage. The candidate should be able to independently execute experiments, analyze formulation and process data, accurately document results and observations, and clearly communicate findings to technical and cross-functional stakeholders.


• The ideal candidate is proactive, adaptable, organized, and scientifically curious, with a strong desire to learn. They are comfortable working in a GMP/SOP-driven environment and can effectively balance hands-on experimental work with digital and analytical responsibilities.

Average candidate

• An average candidate may have laboratory experience but require some guidance in designing and executing formulation experiments, interpreting data, and applying experimental findings to formulation and process decisions. They may have some exposure to oral solid dosage form development and characterization techniques, but limited hands-on experience with these areas and with solubility-enabling formulation approaches.


• Understanding of typical unit operations for the manufacture of oral solid dosage forms, including granulation, roller compaction, drying, milling, blending, compression, and film coating. Knowledge of solubility-enabling formulation approaches for oral drug products would be desirable.


• Understanding of analytical and solid-state characterization such as DSC, HPLC, UV, PXRD as well as characterization of pharmaceutical materials and dosage forms, including density, friability, disintegration, dissolution, and flowability.


• Excellent oral and written communication skills with the ability to communicate effectively with team members, peers, management, and external partners.

Salary and Other Compensation:

The annual [salary/hourly rate] for this position is between$25.00 - $26.00 per hour.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

• [medical insurance]


• [dental insurance]


• [vision insurance]


• [401(k) retirement plan]


• [life insurance]


• [long-term disability insurance]


• [short-term disability insurance]


• [paid parking/public transportation]


• [Paid time off]


• [Days/hours of paid sick and safe time]


• [Days/hours of paid vacation time]


• [Weeks of paid parental leave]


• [Paid holidays annually]


• [any additional benefits applicable]