Associate Director, External Manufacturing
$150,000–$170,000 year
On-siteVerona, Wisconsin, United States
Job Summary
Lead end-to-end CDMO relationship management for a portfolio of 1–3 strategic partners, serving as the single point of accountability for drug substance, conjugation, and drug product manufacturing. Drive on-time, in-specification delivery of clinical and commercial supply while overseeing technology transfers, batch records, and risk mitigation for critical raw materials. Act as the primary technical interface across Process Development, Quality, Regulatory, and Supply Chain to ensure robust, compliant, and cost-effective production of siRNA-based therapeutics. Manage inspection readiness for global regulatory filings and support late-stage clinical and commercial launch activities. This role is onsite in Verona, WI, with an expectation to work five days a week.
Required Qualifications
- PhD., M.S., or B.S. in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline
- 8+ years of experience in biopharmaceutical technical operations, external manufacturing, or CMC, with progressive responsibility (less if Ph.D.)
- Demonstrated success directly managing CDMO relationships as the primary technical/business owner, including technology transfer, GMP manufacturing oversight, and performance management
- Direct experience with synthetic oligonucleotide (siRNA or ASO) manufacturing required
- Proven ability to lead and influence in a highly matrixed, cross-functional environment spanning PD, AD, Quality, Regulatory, and Supply Chain
- Experience supporting late-stage clinical programs and/or commercial launches, including PPQ and BLA/NDA-supporting activities
- Strong working knowledge of FDA, EMA, and ICH GMP requirements; experience supporting regulatory inspections at CDMOs
- Excellent written and verbal communication skills, with the ability to translate technical detail into executive-level recommendations
- Candidates must have current, valid authorization to work in the country where this role is located
- This role is based in onsite with an expectation to be in the office five days a week
Desired Qualifications
- experience with GalNAc conjugates or other targeted RNA delivery technologies strongly preferred
- Able to lead and coordinate large, complex strategy projects, with minimal direction
- Experience developing operations network strategies for a growing global market
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