Scientist - Process Development - IV

Spectraforce Technologies, Inc.; San Mateo (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Scientist - Process Development - IV for an onsite Foster City position. The role focuses on biologics CMC development, formulation development, and drug product process development in a fast-paced team.

The successful candidate will design and execute development work, drive innovation, and contribute to documentation, data integrity, and regulatory deliverables while collaborating with internal and external stakeholders.

Qualifications

• PhD/MS/BS with required years of industrial experience in biologics CMC development.
• Hands-on laboratory experience required.
• Experience with monoclonal antibodies, bispecifics, ADCs, fusion proteins, and other complex biologics formats preferred.

Responsibilities

• Design and execute formulation and DP process development work packages.
• Drive innovation and share knowledge through publications and presentations.
• Demonstrate analytical/biophysical characterization and process development techniques.
• Ensure data integrity and good documentation practices.
• Author protocols, reports, and regulatory dossiers.
• Collaborate with internal and external stakeholders in project meetings.
• Support department initiatives to drive scientific innovation.

Skills

Hands-on laboratory experience

Biologics CMC development

Formulation development

Drug Product process development

Publications presentations

Education

PhD in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related field

MS with 6+ years experience

BS with 8+ years experience

Job description

Title:Scientist - Process Development - IV

Location: Onsite position - Foster City 5 days/week

Duration: 12 months

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.

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.