Associate Scientist, Purification Process Development

ACL Digital; Oceanside (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

ACL Digital is seeking an Associate Scientist, Purification Process Development in Oceanside, CA onsite for a 12-month assignment. The role focuses on designing and executing purification process development studies, supporting scale-up and tech transfers to GMP facilities.

The candidate will utilize AKTA chromatography systems, drive data integrity, and mentor junior staff while contributing to pivotal clinical programs. Strong communication and collaboration are essential.

Qualifications

• M.S. with 2+ years or B.S. with 4+ years in a relevant scientific discipline.
• Hands-on laboratory operations experience with purification processes.
• Experience with data integrity and scientific reporting.

Responsibilities

• Plan and execute purification process development studies and scale-up.
• Analyze data from laboratory experiments and author protocols/reports.
• Support process transfers to GMP facilities and manufacturing.
• Provide technical support for investigations and maintain documentation.
• Mentor junior team members and contribute to lab development.

Skills

Laboratory purification operations

Data integrity

Cross-functional collaboration

Scientific writing

Education

MS in relevant science

BS in relevant science

Tools

AKTA chromatography

UNICORN software

Job description

Job Title: Associate Scientist, Purification Process Development

Location: Oceanside, CA

Duration: 12 months

Description:

Official Job Title: Associate Scientist, Purification Process Development

Location: Oceanside, CA (Onsite 5 days)

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.