Job Description

Locations

• US - California - Thousand Oaks

Skills Required

• formulation developmentintermediate
• high-throughput formulation developmentintermediate
• DoEintermediate
• clinical-stage developmentintermediate

Required Qualifications

• Doctorate degree PhD OR PharmD OR MDORMaster’s degree and 3 years of Scientific experienceORBachelor’s degree and 5 years of Scientific experience (experience, 3 years)

Preferred Qualifications

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 2–4 years of postdoc or industry experience. (experience, 4 years)
• Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct biologics drug product formulation experience is strongly preferred. (experience)
• Demonstrated understanding of biologics drug product development considerations, including protein degradation, quality attributes, and product/process comparability. (experience)
• Experience integrating formulation, stability, and analytical data to advance biologics candidates from discovery or preclinical development into clinical manufacturing is highly desirable. (experience)
• Hands-on experience with high-throughput formulation development, automated liquid handling systems (e.g., Hamilton, Tecan, Beckman Coulter, Opentrons, or equivalent), and robotic laboratory workflows. (experience)
• • Experience designing and executing high-throughput formulation screening studies for biologics, including automated preparation, analytical characterization, and data analysis. (experience)
• • Experience implementing laboratory automation, workflow digitization, and electronic data capture to improve R&D productivity. (experience)
• • Familiarity with DoE, high-throughput experimentation, laboratory robotics, and workflow orchestration for formulation and process development. (experience)
• Strong foundation in analytical and biophysical techniques relevant to biologics and biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.). (experience)
• Familiarity with clinical-stage development, manufacturability, and risk-based decision-making. (experience)
• Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline R&D and optimize performance. (experience)
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs). (experience)
• PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 2–4 years of postdoc or industry experience. (experience, 4 years)
• Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct biologics drug product formulation experience is strongly preferred. (experience)
• Demonstrated understanding of biologics drug product development considerations, including protein degradation, quality attributes, and product/process comparability. (experience)
• Experience integrating formulation, stability, and analytical data to advance biologics candidates from discovery or preclinical development into clinical manufacturing is highly desirable. (experience)
• Hands-on experience with high-throughput formulation development, automated liquid handling systems (e.g., Hamilton, Tecan, Beckman Coulter, Opentrons, or equivalent), and robotic laboratory workflows. (experience)
• • Experience designing and executing high-throughput formulation screening studies for biologics, including automated preparation, analytical characterization, and data analysis. (experience)
• • Experience implementing laboratory automation, workflow digitization, and electronic data capture to improve R&D productivity. (experience)
• • Familiarity with DoE, high-throughput experimentation, laboratory robotics, and workflow orchestration for formulation and process development. (experience)
• Strong foundation in analytical and biophysical techniques relevant to biologics and biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.). (experience)
• Familiarity with clinical-stage development, manufacturability, and risk-based decision-making. (experience)
• Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline R&D and optimize performance. (experience)
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs). (experience)

Responsibilities

• Let’s do this. Let’s change the world. In this vital role you will join Pre-Pivotal Drug Product Technologies group, responsible for early-stage drug product development across diverse modalities, with a strong emphasis on monoclonal antibodies, multispecifics and other biologic modalities. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs); establishing robust, scalable fill/finish processes for complex biologic drug products; and authoring and supporting high quality regulatory submissions.
• Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.
• Plan and execute formulation and fill/finish process studies for early-stage programs.
• Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on biologics drug product formulation, handling, and lab-scale sterile filling.
• Build process understanding across unit operations to support scalable drug product development.
• Evaluate in-use compatibility and drug product stability under clinical conditions.
• Investigate biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.
• Design, develop, and execute automated high-throughput formulation screening workflows to accelerate excipient selection, formulation optimization, and processability assessments.
• Develop and implement laboratory automation solutions, including robotic liquid handling systems and automated sample preparation workflows, to improve experimental throughput, reproducibility, and data quality.
• Partner with automation engineers, data scientists, and digital teams to deploy integrated automated workflows that support formulation development, stability studies, and process characterization.
• Utilize design of experiments (DoE), high-throughput experimentation, and automated data analysis pipelines to efficiently explore formulation design space and support data-driven decision making.
• Identify and address technology gaps impacting biologics stability, protein-excipient interactions, and process-related stress responses.
• Apply machine learning, AI, laboratory automation, and advanced data science to predictive modeling, workflow acceleration, and decision-making.
• Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.
• Author technical documents, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.
• Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns.
• Present findings to internal/external stakeholders and participate in cross-functional teams.
• Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.
• Plan and execute formulation and fill/finish process studies for early-stage programs.
• Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on biologics drug product formulation, handling, and lab-scale sterile filling.
• Build process understanding across unit operations to support scalable drug product development.
• Evaluate in-use compatibility and drug product stability under clinical conditions.
• Investigate biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.
• Design, develop, and execute automated high-throughput formulation screening workflows to accelerate excipient selection, formulation optimization, and processability assessments.
• Develop and implement laboratory automation solutions, including robotic liquid handling systems and automated sample preparation workflows, to improve experimental throughput, reproducibility, and data quality.
• Partner with automation engineers, data scientists, and digital teams to deploy integrated automated workflows that support formulation development, stability studies, and process characterization.
• Utilize design of experiments (DoE), high-throughput experimentation, and automated data analysis pipelines to efficiently explore formulation design space and support data-driven decision making.
• Identify and address technology gaps impacting biologics stability, protein-excipient interactions, and process-related stress responses.
• Apply machine learning, AI, laboratory automation, and advanced data science to predictive modeling, workflow acceleration, and decision-making.
• Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.
• Author technical documents, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.
• Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns.
• Present findings to internal/external stakeholders and participate in cross-functional teams.

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