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 in a highly collaborative team focusing on high throughput and automation workflows to drive formulation screening and advance drug product commercialization.
Responsibilities include: • Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development by:
- Supporting and executing formulation assessments by utilizing high-throughput technologies and workflows, working closely with program teams on fast-paced projects.
- Supporting studies on advancing automation technologies regarding liquid handling robots, plate-based buffer exchange systems, and high throughput protein characterization assays. • Evaluate product and process performance through analytical testing (e.g., U/HPLC, CEX, particle analysis, physical properties, etc.) and perform subsequent data analysis and method compliance assessments as appropriate. • Identify and implement innovative solutions by applying basic science/engineering skills to increase throughput, improve quality, and streamline data capture and analysis. • Effectively communicate and closely collaborate with the colleagues in the automation team to coordinate, organize and execute studies • Participate in team meetings by sharing study designs, results, and technical challenges. • Author and review technical documents, such as technical presentations, protocols, and reports, while ensuring a high standard of data accuracy and integrity
Preferred Qualifications: • Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or related subject area. • Prior knowledge or industry experience (2+ years) of pharmaceutical/biotechnology process development, protein handling, and processing with a focus in formulation development • Hands-on experience in executing protein characterization techniques, i.e. SEC-UHPLC, CEX-UHPLC, concentration measurement via UV-Vis, pH, viscosity and other analytical testing. • Hands-on experience in designing and executing automation and high throughput screening studies on liquid handling platforms (e.g. Tecan, Hamilton, Andrew Alliance, Unchained Labs, etc.) • 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 • Good organizational skills with strong attention to detail. • Excellent communication (oral and written).
Basic Qualifications: • B.S. with 2-5 year experience, M.S. with 0-3 year experience, with degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or related degree with a biotechnology, pharmaceutical or vaccine background. Biotech/pharmaceutical industry experience preferred.
Basic Qualifications
0+ Years w/ Relevant MS or equivalent 2+ Years w/ Relevant BS or equivalent 4+ Years w/ Relevant AS or equivalent 6+ Years w/ HS
Top Must Have Skill Sets: • 2+ years of relevant lab experience in industry. • Related degrees in related fields: Chemical Engineering, Biochemistry, Biology, or other biotechnology or pharmaceutical subjects. • Excellent communication (oral and written). • Processing and handling proteins and other bio pharma materials.
Preferred: Hands-on experience in executing protein characterization techniques, i.e. SEC-UHPLC, CEX-UHPLC, concentration measurement via UV-Vis, pH, viscosity and other analytical testing.
Day to Day Responsibilities: • 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