Senior Associate - Pivotal Drug

Senior Associate - Pivotal Drug

Alternate/Related Job Titles:

• QC Microbiologist
• Analytical Chemist
• Process Development Scientist
• Drug Substance Manufacturing / Analytical Engineer

Location: Thousand Oaks, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $26.00 $32.00 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

This position is for a Process Development Senior Associate joining the Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late-stage drug product formulation and fill/finish process development for large molecule modalities (e.g., monoclonal antibodies, bispecific T-cell engagers (BiTEs), fusion proteins, etc.). The Senior Associate will work closely with the automation team responsible for the technical aspects of enabling automation and advancing the client's drug product commercialization. The role is 100% lab-based.

Key Responsibilities

• Plan and execute studies to characterize and enable implementation of new technologies that advance state-of-the-art automation, high-throughput screening, and analytical capabilities.
• Plan and execute studies to characterize drug product formulations and processes.
• Effectively communicate and collaborate with colleagues inside the automation team to coordinate, organize, and execute studies.
• Evaluate product attributes through analytical testing, e.g., measuring pH, conductivity, osmolality, protein concentration, SEC, CEX, and subvisible and visible particle characterization.
• Apply fundamental scientific and engineering principles (chemistry, kinetics, statistics, etc.) to solve challenges.
• Participate in data management initiatives, such as integration of data from lab instruments with Electronic Lab Notebooks (ELN) to streamline and automate data collection.
• Author/review technical documents, such as technical presentations, protocols, and reports.
• Actively involve and support safety and compliance initiatives in the lab, including resolution of safety observations.
• Lab-based study support and analytical testing.
• Data analysis and documentation.
• Author, review, and data verify technical documents (e.g., presentations and reports).
• Consistent communication of progress through meetings.

Required Skills

• Extensive laboratory background.
• Experience in analytical testing.
• Experience characterizing protein structures (SEC, CEX, UV-Vis, pH).
• Peptide synthesis and purification.
• Small-protein purification process development.
• Familiarity with protein handling and processing through biotech/pharmaceutical industry experience.
• Excellent communication skills (oral and written).
• Processing and handling proteins and other biopharmaceutical materials.

Preferred Skills

• Prior knowledge or industry experience (1+ years) of pharmaceutical/biotechnology process development and protein handling and processing, especially formulation development and Drug Product unit operations, e.g., UF/DF, filling, lyophilization.
• Hands-on experience executing protein characterization techniques, i.e., SEC-UHPLC or CEX-UHPLC, concentration measurement via UV-Vis, pH, viscosity, and other analytical testing.
• Basic understanding of, or prior experience with, automated and high-throughput laboratory systems, including liquid-handling platforms and analytical instruments.
• High-throughput experiment experience is highly preferred.
• UF/DF experience is highly preferred.
• Knowledge of AI and its application in lab work.
• Industry experience is preferred over university or academic experience.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions/SOPs, and comply with company policies.
• Critical thinking, problem-solving, and independent research skills.
• Good organizational skills with strong attention to detail.
• Ability to elevate relevant issues to project lead and line management.
• Self-motivation, adaptability, and a positive attitude with enthusiasm to learn new techniques.
• Ability to work independently and as part of a team with internal and external partners.
• Ability to participate and work effectively in a fast-paced, dynamic, and highly matrixed team environment.

Education Requirements

• Bachelor's degree (with 2+ years of industry experience) or master's degree in Chemical Engineering, Chemistry, Biochemistry, Biology, or related subject area with biotechnology or pharmaceutical background.
• Alternatively: Associate's degree and 4 years of experience, or High school diploma/GED and 6 years of experience.

Required Experience

• Minimum 2+ years of relevant lab experience in industry (with Bachelor's degree); or master's degree with relevant background; or Associate's degree with 4 years of experience; or High school diploma/GED with 6 years of experience.

Nice-to-Have Experience

• Prior knowledge or industry experience (1+ years) of pharmaceutical/biotechnology process development.

Important Notes

• Interview Process: Phone screen followed by a virtual panel interview. Team screens with hiring manager (~5 applicants), then virtual interviews with hiring manager and team (2 3 applicants).

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-17736

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