Laboratory Operation Sr Associate

Job Description

Job Description

Fully Onsite | Thousand Oaks - Must be a local

Shift : Standard 8-5 local hours (Monday to Friday)

Process Development Sr Associate - Pivotal

Preferred Qualifications :

Degree in Engineering, Chemistry, Pharmaceutics, Materials Science, or related discipline.

2+ years of relevant lab experience.

Understanding of physical / chemical stability of proteins.

Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with procedures and policies.

Proficient computer skills.

Self-motivation, adaptability and a positive attitude.

Critical thinking, problem solving, and independent research skills.

Good organizational skills with strong attention to detail.

Excellent communication (oral and written).

What you will do :

Let’s do this. Let’s change the world. In this vital role you will work in our 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 various biological modalities (large molecule, RNA, virus). Additionally, the position works on ways to improve how data is analyzed and the use of statistical models to inform decisions throughout drug product development. The Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.

Responsibilities :

• Plan, design, execute, and document laboratory studies related to formulation and fill / finish process development in support of product commercialization and life cycle management
• Work independently, taking ownership of projects and self-managing work packages with appropriate communication and partner concern.
• Plan, design, execute and document laboratory studies related to formulation and fill / finish process development in support of product commercialization and life cycle management.
• Apply basic science / engineering skills and first principle modeling to solve technical problems
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management
• Perform data analysis using advanced statistical / analytical techniques with a proficiency in statistical analysis software
• Provide support, as needed, to clinical and commercial fill / finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes / improvements
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs
• Ability to travel domestically and internationally up to 10% of the time

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The process development biotech / pharma professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications :

Master’s degree

OR

Bachelor’s degree and 2 years of scientific experience

Or

Associate’s degree and 4 years of scientific experience

Or

High school diploma / GED and 6 years of scientific experience

Top 3 Must Have Skill Sets :

Lab Experience : Hands-on experience in a laboratory setting is crucial. This includes familiarity with lab equipment, techniques, and safety protocols.

Work in a Team : The ability to collaborate and work well within a team is essential. This involves effective communication, cooperation, and the ability to contribute to group projects.

Communication : This includes drafting technical reports, presenting study objectives and results, and facilitating discussions.