Senior Associate

Planet Pharma; Thousand Oaks (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

Planet Pharma seeks a Process Development Senior Associate to join the Pivotal Drug Product Technologies Group in Thousand Oaks, CA. You will drive studies advancing automation, characterize drug product formulations, and collaborate with the automation team to enable commercialization.

You’ll apply chemistry, kinetics and statistics to solve challenges, manage data via ELN, and prepare technical documents while upholding safety and compliance. This role emphasizes independent work and teamwork.

Qualifications

• Bachelor’s degree with 2+ years of industry experience or Master’s in a related field with biotech/pharma background.
• Familiarity with protein handling and processing in biotech/pharmaceutical settings.
• Experience with protein characterization techniques (SEC-UHPLC or CEX-UHPLC).
• Understanding of automated/high-throughput laboratory systems and liquid-handling platforms.
• Ability to learn new techniques, follow SOPs and work within policies.
• Strong problem solving, organizational skills and attention to detail.

Responsibilities

• Plan and execute studies to enable automation and high-throughput capabilities.
• Plan and execute studies to characterize drug product formulations and processes.
• Collaborate with automation team to coordinate study activities.
• Evaluate product attributes through analytical testing (pH, conductivity, osmolality, protein concentration, SEC, CEX, particles).
• Apply scientific and engineering principles to solve challenges.
• Support data management, ELN integration and data automation initiatives.
• Author and review technical documents, presentations, protocols, and reports.
• Promote safety and compliance initiatives in the lab.

Skills

Protein handling

Analytical testing

Data management

Team collaboration

Education

Bachelor's degree (2+ yrs) or Master's in Chemical Engineering / Chemistry / Biochemistry / Biology with biotech/pharma background

Tools

UHPLC

SEC-UHPLC

CEX-UHPLC

ELN

Job description

Currently 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 include:

• 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