Scientist – Process Development (Biologics)

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Job Title: Scientist – Process Development (Biologics)

Position Details

• Location: Foster City, CA
• Duration: 1 Year
• Work Mode: Onsite, 5 days per week
• Candidate Preference: Local candidates only
• Silicon Star is PV

Job Description:

The Scientist – Biologics Pivotal Formulation and Process Development will be part of a collaborative and interdisciplinary CMC development team focused on advancing medicines into clinical development using innovative technologies and methodologies.

The ideal candidate must have recent, hands-on laboratory experience in biologics formulation development and Drug Product (DP) process development, particularly for clinical-stage or late-stage biologics.

This is a bench scientist role, not a strategy, project management, Medical Affairs, or publications-management position. The candidate should be able to independently execute laboratory experiments and contribute from day one with minimal ramp-up.

Key Responsibilities

1. Design and execute formulation development and Drug Product (DP) process development activities.
2. Perform hands-on laboratory experiments involving:
   • Biologics formulation development and optimization
   • DP manufacturing process development
   • Fill/finish operations
   • Mixing and filtration studies
   • Freeze-thaw studies
   • Shipping and hold studies
   • Stability studies
   • Clinical in-use compatibility evaluations involving IV bags, tubing, filters, and syringes
3. Conduct analytical and biophysical characterization of biologics formulations.
4. Support the development of clinical-stage and late-stage biologics, including complex biologic molecules.
5. Prepare and review technical documents, including protocols, reports, and regulatory documentation.
6. Contribute to regulatory dossier preparation, including CTD Module 3 content.
7. Follow data integrity requirements and Good Documentation Practices (GDP).
8. Collaborate with internal teams and external stakeholders on project activities.
9. Contribute to technical innovation, process improvements, publications, and external presentations where applicable.

Required Qualifications

Candidates must meet one of the following educational and experience requirements:

• Ph.D.: In Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field, with 1+ years of industrial experience.
• Master’s Degree: In a relevant scientific field, with 6+ years of industrial experience.
• Bachelor’s Degree: In a relevant scientific field, with 8+ years of industrial experience.

Hands-on laboratory experience is mandatory.

Must-Have Skills

• Direct experience in biologics formulation development.
• Drug Product (DP) process development experience.
• Hands-on laboratory execution and optimization of formulations and manufacturing processes.
• Experience with clinical-stage or late-stage biologics.
• Experience with monoclonal antibodies (mAbs).
• Practical knowledge of analytical and biophysical characterization techniques.
• Experience preparing technical protocols, reports, and scientific documentation.
• Strong understanding of data integrity and Good Documentation Practices.

Preferred / Good-to-Have Skills

• Experience with bispecific antibodies, antibody-drug conjugates (ADCs), and fusion proteins.
• Pivotal-stage CMC development experience.
• Experience with SEC, CE-SDS, icIEF, DLS, DSC, and sub-visible particle analysis.
• Experience with clinical in-use compatibility studies.
• Experience preparing regulatory dossier content, particularly CTD Module 3.
• Publications, external presentations, and research-driven innovation experience.

Important Screening Notes

• Prioritize candidates with recent and proven hands-on bench experience in biologics formulation and DP process development.
• Candidates must be comfortable independently performing laboratory experiments from day one.
• Strong preference for candidates with mAb experience and exposure to complex biologics such as bispecific antibodies, ADCs, or fusion proteins.
• Do not prioritize profiles focused mainly on project management, regulatory writing, Medical Affairs, or publications management without direct laboratory experience.
• Please submit local candidates who can work onsite in Foster City, CA, five days per week.

Client Core Values

• Integrity – Doing What’s Right
• Inclusion – Encouraging Diversity
• Teamwork – Working Together
• Excellence – Being Your Best
• Accountability – Taking Personal Responsibility