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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
- Design and execute formulation development and Drug Product (DP) process development activities.
- 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
- Conduct analytical and biophysical characterization of biologics formulations.
- Support the development of clinical-stage and late-stage biologics, including complex biologic molecules.
- Prepare and review technical documents, including protocols, reports, and regulatory documentation.
- Contribute to regulatory dossier preparation, including CTD Module 3 content.
- Follow data integrity requirements and Good Documentation Practices (GDP).
- Collaborate with internal teams and external stakeholders on project activities.
- 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
