Process Development Scientist

Pacer Group; San Mateo (CA); On-site; USD 84,000 - 114,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

Pacer Group in Foster City, CA is seeking a Scientist - Process Development – IV for an onsite contract role. The position supports biologics formulation and drug product process development within a collaborative CMC team, applying state-of-the-art techniques to advance medicines toward clinical studies.

Responsibilities include designing development work packages, driving process optimization, ensuring data integrity, and presenting findings to internal and external stakeholders.

Qualifications

• Ph.D. in Pharmaceutical Science or related field required.
• MS with 6+ years, BS with 8+ years of industrial biologics CMC experience.
• Hands-on laboratory experience required.
• Experience with formulation development and DP processing for biologics.

Responsibilities

• Design and execute formulation and DP process development work packages.
• Drive innovation and publish or present findings.
• Demonstrate understanding of analytical/biophysical characterization; lead lab execution.
• Maintain data integrity and rigorous documentation.
• Authors protocols, reports, and regulatory dossiers.
• Collaborate with internal and external stakeholders in meetings.
• Support cross-functional initiatives to drive scientific innovation.

Skills

Laboratory experience

Formulation development

DP process development

Monoclonal antibodies

Education

Ph.D. in Pharmaceutical Science

MS in Chemistry or related field

BS in Biology or related field

Job description

Job Title: Scientist - Process Development – IV

Location: Foster City, CA 94404

Work arrangement: Onsite

Job Type: Contract

Pay Rate: $72/hr on W2

Schedule: Standard hours

Description:

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.

Qualification

• 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.

BENEFITS

Medical | Dental | Vision | 401(k)

EEOC Compliance

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.

DISCLAIMER

AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.