Senior Director, Oligonucleotide Process Development
6 days ago
At BioSpace, Inc., we are seeking an experienced Associate Director to lead our Oligonucleotide Process Development team. As a key member of our Technical Development department, you will be responsible for managing all aspects of Oligonucleotide process development and manufacturing, including scale-up to Phase 3 and commercial.
Key Responsibilities:- Assume technical responsibility for Oligonucleotide CMO process development and manufacturing for one or more programs.
- Provide subject matter expert (SME) guidance for Oligonucleotide process development and scale-up.
- Responsible for developing and executing late-stage manufacturing strategy to meet our advancing pipeline.
- Work with CMOs and QA to ensure timely release of Oligonucleotide intermediate.
- Work with QC, QA, and Analytics & Formulations to refine Oligonucleotide specifications for late-stage clinical trials and commercialization.
- Work with CMOs, QA, and Supply Chain to ensure timely delivery of Oligonucleotide to DS manufacturing sites.
- Provide Person-In-Plant support for Oligonucleotide manufacturing runs.
- Author relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
- Coordinate Oligonucleotide vendor regulatory support as needed and ensure communication between BioSpace RA and Oligonucleotide CMOs.
- Work with the QC stability team to ensure that Oligonucleotide shelf-life extensions are executed in a timely manner. Provide SME oversight of Oligonucleotide stability programs.
- Manage Oligonucleotide tech transfer activities between CMOs and/or within CMOs for scale-up.
- Minimum Bachelor's degree in chemistry, chemical engineering, pharmaceutical science, or related field required. Master's or PhD preferred.
- Minimum of 8 years of pharmaceutical industry experience in Oligonucleotide synthesis and purification at large scale.
- Expertise in Oligonucleotide process development, manufacture, scale-up, and technology transfer.
- Prior experience in clinical Phase 3/commercial readiness process development and manufacturing, Process Characterization, and PPQ with knowledge of QA and Regulatory requirements for late-stage clinical and commercial manufacturing.
- Experience in GMP manufacturing and a strong understanding of US, EU, and JP regulations are required.
- Prior IND and BLA filing experience.
- Experience working with third-party CMOs.
- The base salary range for this role is $167,000 - $194,000. The final compensation will be commensurate with relevant experience, skillset, internal equity, and market factors.
- A competitive compensation and benefits package, including the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match.
- A comprehensive wellness program, including coverage for medical, dental, vision, and LTD, and four weeks of time off.
- A commitment to learning and development, including a variety of programming internally developed by and for BioSpace employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
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