Associate Scientist

LeadStack Inc.; Oceanside (CA); On-site; USD 55,000 - 62,000; Full time

Job summary

LeadStack Inc. is seeking an Associate Scientist for Purification Process Development in Oceanside, CA. This on-site role focuses on pivotal and commercial purification development, including process characterization and platform evolution.

The incumbent will lead projects, design experiments, and ensure timely GMP/non-GMP substance production with high success rates. The candidate should have an MS with 2+ years or a BS with 4+ years in a relevant science, plus hands-on purification operations

Qualifications

• MS with 2+ years or BS with 4+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• Experience with purification process operations and lab automation is preferred.
• Strong data integrity and scientific writing skills required.

Responsibilities

• Contribute to experimental design and plan purification development studies.
• Support process transfer to GMP facilities and scale-up activities.
• Analyze data from laboratory experiments and author protocols/reports.
• Mentor junior team members in purification strategies and process transfer.
• Maintain high-quality documentation in ELN, protocols, and reports.
• Lead purification platform development and evaluate new technologies.

Skills

Experimental design

Data analysis

Documentation

Mentoring

Cross-functional

Education

MS with 2+ years or BS with 4+ years in a relevant scientific discipline

Tools

AKTA chromatography

UNICORN software

Job description

Job Title: Associate Scientist, Purification Process Development

Location: Oceanside, CA (Onsite 5 days)

Duration: 12 Months Contract

Pay rate: $40/hr - $45.27/hr on W2

Description:

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 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.