Senior Director, Oligonucleotide CMC & Manufacturing

Atrium Therapeutics; San Diego (CA); On-site; USD 266,000 - 295,000; Full time

Benefits offered by this job

Stock options

401(k) with employer match

Comprehensive wellness program

Unlimited time off

Job summary

A biopharmaceutical company in San Diego is seeking a Director/Senior Director of AOC Process Development and Manufacturing to oversee oligonucleotide synthesis and manufacturing. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and a deep understanding of regulatory standards. Responsibilities include leading tech transfer for various programs, managing CMC activities, and ensuring compliance with FDA and EMA regulations. The role offers a competitive salary and benefits, including stock options and unlimited time off.

Qualifications

• Minimum 10 years of pharmaceutical industry experience in oligonucleotide synthesis.
• Expertise in regulatory requirements for late-stage manufacturing.
• Proven CMC leadership experience.

Responsibilities

• Lead oligonucleotide process development and manufacturing activities.
• Provide subject matter expertise in oligonucleotide processes.
• Author and review regulatory submissions related to manufacturing.

Skills

Oligonucleotide process development

Leadership

Regulatory knowledge (cGMP, FDA)

Analytical methods

Communication skills

Education

Bachelor's degree in chemistry or related field

Advanced degree (MS/PhD)

Job description

A biopharmaceutical company in San Diego is seeking a Director/Senior Director of AOC Process Development and Manufacturing to oversee oligonucleotide synthesis and manufacturing. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and a deep understanding of regulatory standards. Responsibilities include leading tech transfer for various programs, managing CMC activities, and ensuring compliance with FDA and EMA regulations. The role offers a competitive salary and benefits, including stock options and unlimited time off.