Scientist - Process Development - IV # 26-24781

Us Tech Solutions; Foster City (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

USTech Solutions in Foster City, CA is seeking a Scientist for Biologics Pivotal Formulation and Process Development to advance medicines into the clinic. You will lead formulation and DP process development, drive innovation, and collaborate across teams in a fast-paced environment.

The role emphasizes hands-on lab work, data integrity, and contributions through publications and external collaborations with a strong emphasis on monoclonal antibodies and complex biologics formats.

Qualifications

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related field with 0+ years.
• M.S. with 6+ years or B.S. with 8+ years of industrial biologics CMC experience.
• Hands-on laboratory experience required.
• Experience with formulation development and DP process development for biologics formats (mAbs, bispecifics, ADCs, fusion proteins).
• Publications and external presentations are preferred.

Responsibilities

• Design and execute formulation and drug product process development work packages.
• Drive innovation and grow technical expertise; engage with external collaborations and publications.
• Demonstrate understanding of analytical/biophysical characterization and lab execution.
• Ensure data integrity and good documentation practices.
• Authors protocols, reports, regulatory dossiers for internal/external audiences.
• Collaborate with internal and external stakeholders in project meetings.
• Support department initiatives to drive scientific innovation.

Skills

Formulation development

DP process development

Analytical techniques

Lab execution

Publications/presentations

Education

Ph.D. in Pharmaceutical Science/related field

M.S. in related field

B.S. in related field

Job description

Duration :

12 Months with possible extension

Overview :

• The Scientist, Biologics Pivotal Formulation and Process Development role is part of the collaborative and interdisciplinary CMC development team aiming to use state-of-the-art technologies and innovative methodologies to advance medicines into the clinic.
• The success candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and spearhead innovations related to formulation and DP process development. S/he will have growth opportunities through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Responsibilities:

• Design and execute formulation and drug product process development work packages, including formulation development, Drug Product manufacturing process development, and clinical in-use evaluations.
• Drive innovation and continuously grow technical expertise; influence internally and externally through publication, presentations, and industrial collaboration representation.
• Demonstrate understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities; lead by example for lab executions.
• Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.
• Authors technical documents such as protocols, reports, regulatory dossier, etc for internal and external audience.
• Effectively collaborates with both internal and external stakeholders in project meetings.
• Support and contribute to department initiatives or cross-functional projects to drive business process excellence and scientific innovation.

Qualifications:

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related scientific fields with 0+ years, M.S. with 6+ years, or B.S. with 8+ years of industrial experience in biologics CMC development.
• Hands-on laboratory experience required.
• Experience with formulation development, Drug Product process development, and clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats strongly desired.
• Publications, external presentations, and the desire to innovate through research strongly preferred.

About USTech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.