Scientist, Formulation and Process Development

ACL Digital; Foster City (CA); Vor Ort; USD 145.000 - 156.000; Vollzeit

Zusammenfassung

ACL Digital in Foster City, CA seeks a Scientist for Biologics Pivotal Formulation and Process Development to lead formulation and Drug Product process development for biologics, including monoclonal antibodies and related formats.

The role emphasizes hands-on lab work, data integrity, and collaboration with internal and external stakeholders to drive innovation and publish results in scientific venues.

Qualifikationen

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or related field.
• 0+ years industrial biologics CMC experience with PhD; 6+ years with MS; 8+ years with BS.
• Hands-on laboratory experience is required.
• Experience with monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats is highly desirable.

Aufgaben

• Design and execute formulation and DP process development work packages.
• Drive innovation and grow technical expertise; publish and present findings.
• Demonstrate understanding of analytical, biophysical characterization, or DP techniques.
• Ensure data integrity and good documentation practices for reports.

Kenntnisse

Hands-on laboratory experience

Scientific communication

Collaboration skills

Ausbildung

Ph.D. in Pharmaceutical Science or related field

M.S. in related field

B.S. in related field

Jobbeschreibung

Job Title: Scientist, Biologics Pivotal Formulation and Process Development

Location: Foster City, CA 94404

Type of Position: Only on W2 basis

Onsite position - Foster City 5 days/week

Job 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.

The pay rate ranges from $70/hr - $75/hr on W2