Our client, a global leader in biotechnology, is seeking a highly motivated Scientist I to join its Formulation Drug Development team for Foster City, CA.
Duration: Long term contract (Possibility of further extension)
Pay Rate: $62/hr on W2 + Medical Benefits, Paid Sick leave, 401K
This role will focus on advancing biologic medicines into clinical development through innovative formulation development, drug product (DP) process development, and clinical in-use evaluations. The ideal candidate will bring hands-on laboratory experience, technical expertise in biologics formulation and process development, and the ability to collaborate with cross-functional teams to drive scientific innovation and support clinical-stage development
Responsibilities:
- Design and execute formulation and drug product process development activities, including formulation development, drug product manufacturing process development, and clinical in- use evaluations.
- Drive scientific innovation, expand technical expertise, and contribute to publications, presentations, and external scientific collaborations.
- Apply knowledge of analytical techniques, biophysical characterization, and process development methods to support drug product development.
- Lead by example in laboratory execution and contribute to the development of new technical capabilities.
- Ensure data integrity and adherence to Good Documentation Practices (GDP) in data collection, analysis, and report generation.
- Critically review internal and external technical documentation for accuracy, completeness, and compliance.
- Author technical documents, including protocols, reports, and regulatory dossier materials for internal and external stakeholders.
Required Qualifications
- Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field with 0+ years of relevant experience; or
- M.S. degree with 6+ years of industrial experience in biologics CMC development; or
- B.S. degree with 8+ years of industrial experience in biologics CMC development.
- Hands-on laboratory experience in biologics formulation or drug product process
- development.
- Experience in biologics CMC development and technical documentation.
Preferred Qualifications:
- Experience in formulation development, drug product process development, and clinical in- use evaluation for:
- Monoclonal antibodies (mAbs)
- Bispecific antibodies
- Antibody-drug conjugates (ADCs)
- Fusion proteins
- Other complex biologics formats
- Experience with analytical methods, biophysical characterization, or drug product process development techniques.
Please respond with your updated resume & contact information to
hr@dawarconsulting.com
/
kavitha@dawarconsulting.com
Best Regards,
DAWAR CONSULTING INC.