Senior Oligonucleotide Process Development and Manufacturing Leader
2 days ago
At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. We are seeking an experienced Associate Director to lead our Oligonucleotide Process Development and Manufacturing team.
Key Responsibilities:- Assume technical responsibility for Avidity's 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 Avidity's 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 Avidity 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.
- Work with the Analytics & Formulations team to design and manage Oligonucleotide development studies supporting commercial launch.
- Provide technical support for Oligonucleotide OOS, OOT, deviations, change controls and nonconformance investigations.
- Support Oligonucleotide process characterization, validation readiness, and PPQ campaign execution.
- Identify and communicate risks to clinical programs and commercial supply chain due to manufacturing delays.
- Participate in developing appropriate risk mitigation strategies for Oligonucleotide supply.
- Adhere to applicable regulations, including FDA, EMA, ICH, GCP, GMP, and Avidity policies and procedures.
- 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.
- Knowledge of cGMP, ICH, FDA, and EMA guidelines regarding Oligonucleotides.
- Proven track record of effective internal and external collaboration.
- Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
- Ability to multi-task, manage conflict, and work in a fast-paced environment.
- 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.
- Avidity offers competitive compensation and benefits, including the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match.
- In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD and four weeks of time off.
- A commitment to learning and development, which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
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