Scientist - Process Development - IV

Novozen Healthcare LLC; Foster City (CA); On-site; USD 66,000 - 72,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

PTO aligned with local laws

Job summary

Novozen Healthcare LLC is seeking a Scientist - Process Development - IV in Foster City, CA. The role is contract-based within a CMC development team, focusing on state-of-the-art formulation and drug product development for biologics.

You will lead lab work and contribute to clinical-stage programs while advancing new capabilities and scientific innovations. The ideal candidate will have a PhD (or MS with substantial experience, BS with 8+ years) in a relevant field, hands-on lab experience,

Qualifications

• Hands-on laboratory experience required.
• Experience with formulation development and DP process development for biologics is strongly desired.
• Publications and external presentations are preferred.

Responsibilities

• Design and execute DP formulation and process development work packages.
• Drive innovation and expand technical capabilities; engage stakeholders.
• Demonstrate proficiency in analytical or biophysical characterization methods.
• Ensure data integrity and thorough documentation for reports.
• Author protocols, reports, and regulatory dossiers for internal/external audiences.
• Collaborate with internal and external teams on project meetings.
• Support cross-functional initiatives to drive process excellence.

Skills

Lab techniques

Education

PhD in Pharmaceutical Science / Chemistry / Biochemistry / Chemical Engineering

MS in related field

BS in related field with 8+ years experience

Job description

Job Title: Scientist - Process Development - IV

Location: Foster City, CA

Duration: Long Term

Employment Type: Contract

Job Responsibilities:

The Scientist, Biologics Pivotal Formulation and Process Development role is part of a collaborative and interdisciplinary CMC development team aiming to use state-of-the-art technologies and innovative methodologies to advance medicines into the clinic.

The successful candidate is expected to bring relevant technical expertise, contribute to key functional strategies, and spearhead innovations related to formulation and Drug Product (DP) process development. The candidate will have growth opportunities through the 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 publications, presentations, and industrial collaboration representation.

Demonstrate understanding of analytical, biophysical characterization, or process development techniques; bring new capabilities and 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.

Author technical documents such as protocols, reports, regulatory dossiers, etc. for internal and external audiences.

Effectively collaborate 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.

Required Qualifications:

Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field with 0+ years of experience; 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 (ADCs), fusion proteins, and other complex biologics formats is strongly desired.

Publications, external presentations, and the desire to innovate through research are strongly preferred.

Pay Scale:

Anticipated hourly pay range: specific range such as ($48/Hr to $52/Hr).

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):

No PTO other than that required by applicable state and local laws.