Associate Scientist, Purification Process Development

VARITE INC; Oceanside (CA); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Health Insurance

Retirement Plans

Legal Service Plans

Job summary

VARITE INC. seeks an Associate Scientist, Purification Process Development in Oceanside, CA to lead purification development for pivotal and commercial biologics programs. You will design experiments, analyze data, and support transfers to GMP facilities while contributing to platform evolution and technology assessments.

This role requires hands-on lab work, collaboration across functions, and adherence to data integrity and safety procedures. Onsite work at our Oceanside facility is expected.

Qualifications

• MS with 2+ years or BS with 4+ years in a relevant scientific discipline.
• Hands-on purification process operations experience including chromatography and tangential flow filtration is preferred.
• Experience with data management and laboratory notebook documentation.

Responsibilities

• Contribute to experimental design and plan purification process development studies.
• Support process scale-up and transfer to GMP facilities.
• Analyze data and author protocols and reports for purification processes.
• Mentor junior team members on purification strategies and process transfer.
• Establish and maintain a state-of-the-art purification lab.

Skills

Purification process development

Lab operations

Data analysis

Cross-functional collaboration

Education

Master's degree (MS) in chemical engineering/biochemistry/biomedical engineering

Bachelor's degree in chemical engineering/biochemistry/bioengineering

Tools

AKTA chromatography systems

UNICORN software

Job description

VARITE is looking for qualified Associate Scientist, Purification Process Development in Oceanside, CA.

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

Associate Scientist, Purification Process Development

Location

Oceanside, CA (5 days onsite)

Contract Duration

12 months

Pay Rate Range

$40.00 - $45.27/hr on W2

Work Authorization

Only USC or GC

HERE'S WHAT YOU'LL DO

Summary

The Associate Scientist, Purification Process Development (Pivotal and Commercial) will be responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for *** biologics entities during pivotal and commercial development phases. He/she will also lead and execute projects for purification process technology development and platform process evolution.

Key Responsibilities:

• Contribute to experimental design. Plan and execute assigned purification process development laboratory studies. Support process scaleup and implementation in internal and external GMP facilities.
• Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author experimental protocols and reports.
• Support process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate***
• Provide technical support for manufacturing atypical event investigations.
• Ensure high-quality documentation in electronic laboratory notebooks, protocols and reports.
• Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer.
• Help to establish and maintain a state-of-the-art purification lab.
• Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials.
• Participate in cross functional initiatives as needed.
• Adhere to department budget and all training, compliance and safety requirements.

Qualifications/Skills/Experience:

• M.S. with 2+ years or BS with 4+ years' experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).

Preferred Qualifications:

• Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, and virus inactivation/removal is required.
• Experience with AKTA chromatography systems and UNICORN software is preferred
• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
• Working knowledge of lab automation, data management, data science, knowledge management and data protection.
• Demonstrated ability to collaborate and influence cross-functionally.
• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
• Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.

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.