Senior Process Development Associate - Pivotal

Thousand Oaks, CA 91320 US

Posted: 11/04/2025 2025-11-04 2025-12-05 Employment Type: Contract Job Category: Scientific Job Number: 623654 Is job remote?: No Country: United States

Job Description

Target PR Range: 19-28/hr

• Depending on experience

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

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 directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

Apply Now:

Apply Online

Apply Later

Send an email reminder to:

Email Address

Share This Job:

Login to save this search and get notified of similar positions.