Scientist - Analytical Operations - II

Spectraforce Technologies; Oceanside (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Spectraforce Technologies in Oceanside, CA is seeking an Associate Scientist, Purification Process Development to lead and execute purification development efforts for pivotal and commercial programs. You will design experiments, analyze data, support tech transfer to GMP facilities, mentor junior staff, and help advance platform purification technologies while ensuring compliance and high-quality documentation.

Qualifications

• M.S. with 2+ years or B.S. with 4+ years in a relevant scientific discipline.
• Hands-on purification process development and laboratory operation experience.
• Familiarity with GMP facilities and data integrity practices.

Responsibilities

• Design and execute purification process development studies.
• Support data collection and analysis from lab experiments and write reports.
• Lead tech transfer to GMP facilities and ensure timely manufacture of drug substances.
• Mentor junior team members and maintain high-quality documentation.

Skills

Purification process development

Data analysis

Laboratory operations

Cross-functional collaboration

Education

M.S. with 2+ years or B.S. with 4+ years in chemical engineering, biochemistry, bioengineering

Tools

AKTA chromatography

UNICORN software

GMP documentation systems

Job description

Associate Scientist, Purification Process Development

Location: Oceanside, CA (Onsite 5 days)

Duration: 12 Months

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 client 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.