Scientist - Process Development - IV*

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title: Scientist - Process Development - IV
Location: Foster City, CA 94404
Duration: 12 months Contract
Payrate: $50/hr - $73/hr on W2

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.

If you have any questions, feel free to call me on (415) 322-5419 or send an email on akarsh.yathiraj@leadstackinc.com
Thanks and Regards
Akarsh Yathiraj Senior Recruiter C. (415) 322-5419 D. (415) 322-5419 A. 611 Gateway Blvd, Ste 120
South San Francisco, CA 94080 W. www.leadstackinc.com