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Process Development Senior Associate
Posted: 01/15/2025
2025-01-15
2025-02-15
Employment Type:
Contract
Job Category: Scientific
Job Number: 4210
Job Description
Our client is currently seeking an external worker to join their 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:
Preferred Qualifications:
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:
- 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
- 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.
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).
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Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.