Scientist - Process Development - IV

VARITE INC; Foster City (CA); On-site; USD 83,000 - 87,000; Full time

Benefits offered by this job

Health Insurance

Retirement Plans

Legal Service Plans

Job summary

VARITE is seeking a Scientist - Process Development - IV in Foster City, CA onsite to join a cross-disciplinary CMC team developing biologics formulations and drug product processes.

The successful candidate will design and execute DP formulation work, drive process development, and contribute to publication and regulatory efforts in a fast-paced environment with collaboration across internal and external stakeholders.

Qualifications

• PhD in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering or related field with 0+ years (MS 6+ yrs, BS 8+ yrs) industrial biologics CMC experience.
• Hands-on laboratory experience required.
• Experience with formulation development and DP process development for biologics formats (mAbs, bispecifics, ADCs, fusion proteins).
• Publications or external presentations preferred.

Responsibilities

• Design and execute formulation and Drug Product process development work packages.
• Drive innovation and contribute to internal/external publications and collaborations.
• Demonstrate understanding of analytical/biophysical characterization and DP techniques.
• Maintain data integrity and robust documentation; draft protocols and reports.

Skills

Lab experience

Formulation development

DP process development

Biologics CMC

Analytical skills

Education

PhD in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering or related

MS with 6+ years of industrial experience

BS with 8+ years of industrial experience

Job description

VARITE is looking for qualified Scientist - Process Development - IV in Foster City, CA 94404 (Onsite)

WHAT THE CLIENT DOES?

An American biopharmaceutical company that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19.

WHAT WE DO?

Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Job Title:Scientist - Process Development - IV

Location: Foster City, CA 94404 (Onsite)

Contract Duration: 12 months with possible extension

Pay Range: $60.00/hr. to $63.30/hr. on W2

HERE’S WHAT YOU’LL DO

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.
• She/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.

BENEFITS:

We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Offering access to attorneys for legal advice and representation.

VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.