Scientist / Senior Scientist, Process Development

Description

Position Title: Scientist / Senior Scientist, Process Development

Reporting to: Director, Chemistry, Manufacturing, and Controls

Employment: Full-Time

Location: On-Site in San Diego, CA

Compensation: $90,000 - $135,0000

(Compensation may vary based on related skills, experience, and relevant key attributes).

n-Lorem Foundation

Though n-Lorem is pioneering a novel non-profit model, to provide personalized experimental ASO treatments for free, for life to patients with the rarest of mutations (nano-rare), we are functionally a biotechnology company. We have a large and growing portfolio of ASO medicine discovery programs, ASO medicines in development and multiple clinical programs.

With a seasoned leadership team and strategic partnerships, the n-Lorem Foundation provides the framework, funds and access for nano-rare patients who are amenable to our technology to receive personalized ASO medicines for free, for life. We hope that you will consider joining us as we strive to change the world, one nano-rare patient at a time.

If you are a process development scientist with strong oligonucleotide chemistry manufacturing experience and would like to join a cohesive, experienced team committed to the belief that we can change the world, one patient, one family at a time, we may have a position for you.

Job Overview:

n-Lorem is seeking an experienced, highly organized, and action-oriented Scientist / Senior Scientist to support discovery and development programs, with a primary focus on manufacturing oligonucleotides at small-scale non-GMP and support GMP manufacturing for preclinical and clinical studies. This role will serve as a key scientific and operational interface between n-Lorem Preclinical Development, CMC, and internal cross-functional teams.

The individual in this role will assume primary responsibility for the planning, execution, and monitoring of small-scale manufacturing, ensuring scientific rigor, data quality, and alignment with program timelines and regulatory expectations. This position requires strong scientific judgment, effective communication, and the ability to independently manage multiple studies in a fast-paced, mission-driven environment. This role will also contribute to the preparation of nonclinical and clinical components of regulatory submissions and related documentation.

Key Responsibilities:

Oligonucleotide Synthesis

• Perform small-scale solid-phase oligonucleotide synthesis using automated synthesizers.
• Prepare and handle reagents, phosphoramidites, and solid supports.
• Monitor synthesis performance and troubleshoot coupling efficiency or instrument issues.
• Conduct cleavage and deprotection reactions according to established protocols.

Purification & Analysis

• Purify crude oligonucleotides using techniques such as HPLC, cartridge purification, or desalting.
• Analyze products using UV-Vis spectroscopy, HPLC, and LC-MS.
• Interpret analytical data to confirm identity, purity, and yield.
• Concentrate and buffer-exchange oligonucleotides as required.

Lyophilization & Final Processing

• Prepare oligonucleotide samples for freeze-drying.
• Operate lyophilizer equipment and ensure proper cycle parameters.
• Accurately weigh, aliquot, and label final products.
• Maintain sample traceability and storage under appropriate conditions.

Documentation & Compliance

• Maintain accurate laboratory notebooks and batch records.
• Document deviations, observations, and troubleshooting activities.
• Assist with developing and following non-GMP work instructions.
• Assist with GMP documentation review and communication with CDMOs.
• Contribute to continuous improvement of internal processes, templates, and best practices for preclinical development.
• Ensure compliance with laboratory safety and chemical handling procedures.

Laboratory Operations

• Maintain laboratory equipment, perform routine calibrations, and coordinate maintenance.
• Develops, optimizes, and executes chromatographic and mass-spectrometry methods (such as HPLC/UHPLC and LC-MS) to verify and qualify analytical procedures.
• Manage chemical inventory and prepare stock solutions.
• Dispose of hazardous waste according to safety regulations.
• Contribute to continuous process improvement initiatives.

Requirements

• U.S. work authorization without the need for current or future sponsorship.
• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular Biology, or related field.
• 3+ years of hands-on laboratory experience in oligonucleotide synthesis or nucleic acid chemistry; 5+ years for Sr. Scientist level.
• Knowledge of phosphoramidite chemistry and solid-phase synthesis principles.
• Experience working with automated synthesizers (AKTA, Mermade-12).
• Experience with preparative purification (AKTA Pure/Avant).
• Experience with HPLC and analytical instrumentation (LC-MS preferred).
• Familiarity with lyophilization processes.
• Proficiency in laboratory documentation and data analysis.
• Basic understanding of GMP principles as it relates to ICH Q7.
• Strong documentation discipline, with attention to traceability.
• High degree of personal accountability and ownership for assigned programs.
• Ability to independently manage multiple studies and priorities with minimal oversight.
• Comfort interfacing with senior internal stakeholders.
• Adaptability and resilience in a fast-moving, mission-driven environment.
• Strong sense of urgency balanced with scientific rigor.
• Collaborative mindset with the ability to work across functions and disciplines .

n-Lorem offers a competitive benefits package including medical, dental, vision, 403(b), four weeks paid vacation, paid sick time, life insurance, employee assistance program. n-Lorem is a small foundation with an extraordinary mission, to provide hope and potentially help to nano-rare patients. Every employee in our organization is a significant contributor to this mission. We know that our work could have a profound impact on the life of a patient today.

n-Lorem is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. n-Lorem is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

For more information on n-Lorem, please visit our website www.nlorem.org

Salary Description

$90,000 - $135,000