Process Development Specialist

Integrated Resources, Inc ( IRI ); Oceanside (CA); On-site; USD 66,000 - 94,000; Full time

Job summary

Integrated Resources, Inc (IRI) seeks an Associate Scientist, Purification Process Development to lead purification development for pivotal and commercial biologics. You will design experiments, scale-up, and support transfers to GMP facilities.

Based onsite in Oceanside, CA, you will mentor junior staff, ensure data integrity, and help advance purification platform technology for clinical trials while adhering to safety and compliance standards.

Qualifications

• Hands-on laboratory operations in purification including centrifugation, filtration, and chromatography.
• Experience with purification platform development and process characterization in GMP environments.
• Familiarity with data integrity, statistics, and cross-functional collaboration.

Responsibilities

• Design and execute purification process development studies and scale-up.
• Analyze data from lab experiments and author protocols/reports with data integrity.
• Support process transfers to internal and contract manufacturing facilities for GMP substances.

Skills

Purification ops

AKTA systems

UNICORN software

Data integrity

JMP

Spotfire

Team collaboration

Tools

AKTA systems

UNICORN

Centrifugation

Job description

Job Title: Purification, Process Development Specialist

Location: Oceanside, CA (Onsite 5 days)

Pay Rate: $31.78 - $45.27/hour on W2

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:

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.