Senior Associate

Job Details

Target PR Range: 19-26/hr DOE

Senior Associate Position for High-thoughput Team

Seeking an external worker to join our Pivotal Drug Product Technologies Group as Process Development Senior Associate 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 drug product commercialization.

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 the colleagues inside the automation team to coordinate, organize and execute studies

• Evaluate product attributes through analytical testing, e.g. measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, 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

Preferred Qualifications

• Prior knowledge or industry experience (1+ years) of pharmaceutical/biotechnology process development and protein handling and processing esp. formulation development and Drug Product unit operations, e.g. UF/DF, filling, lyophilization

• Hands-on experience in 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.

• 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

• Selfmotivation, adaptability andapositive 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

Basic Qualifications

• Bachelors degree (with 2+ yrs of industry experience) or masters degree in Chemical Engineering, Chemistry, Biochemistry, Biology, or related subject area with biotechnology or pharmaceutical background.

• Familiarity with protein handling and processing through biotech/pharmaceutical industry experience

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

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