Director/Senior Director, Analytical Development

5amventures; Emeryville (CA); In loco; USD 180.000 - 230.000; Tempo pieno

Descrizione del lavoro

Prolynx is seeking a Director of Analytical Development in Emeryville, CA, to lead the development, qualification, validation, and implementation of analytical methods for preclinical and clinical programs. This role drives the analytical strategy across starting materials, drug substance, and drug product, and oversees CRO/CDMO partnerships.

The ideal candidate will be scientifically rigorous, hands-on, and capable of scaling an Analytical Development organization while solving complex

Competenze

• Experience taking analytical methods from early development through qualification/validation.
• Experience with peptides, PEGylated molecules, and complex biologics/bioconjugates.
• Ability to grow Analytical Development teams and manage CRO/CDMOs.

Mansioni

• Lead development, qualification, validation, and implementation of analytical methods.
• Define analytical development strategy across starting materials, drug substance, and drug product.
• Collaborate with internal teams and external CRO/CDMOs to advance programs.

Conoscenze

Analytical development leadership

Method qualification/validation

GMP implementation

Peptides

PEGylated molecules

Biologics/bioconjugates

CDMOs management

Descrizione del lavoro

THE COMPANYProlynx is a preclinical biotechnology company with a vision to become the industry leader in ultra-long-acting medicines that improve outcomes for patients with obesity, cardiometabolic, and other diseases. The company is developing a next-generation portfolio of incretin and non-incretin therapeutics designed for once-monthly and once-quarterly dosing. Its proprietary, first-in-category platform uses a hydrogel-based microsphere technology with independently tunable release-linker chemistry to enable highly predictable pharmacokinetics and sustained drug exposure. Prolynx is backed by leading investors including 5AM Ventures, OrbiMed, and Monograph Capital and is based in Emeryville, CA.

Join a multidisciplinary team of talented scientists developing innovative and differentiated medicines - where we pursue purposeful science and let data and patient needs drive decisions. Prolynx provides an environment where you work, learn, and grow alongside experienced drug developers, inventive scientists, and business professionals. Bring your passion, creativity, and energy to our mission. At Prolynx, contributions are valued regardless of title, people are trusted to own their area of expertise, and teammates readily step in to help one another. We share what we know and succeed together. If that sounds like the place for you, we'd like to meet you.

POSITION SUMMARYWe are seeking a highly motivated and experienced Director of Analytical Development to lead the development, qualification, validation, and implementation of analytical methods supporting our preclinical and clinical-stage programs.

The Director will be responsible for establishing and executing the analytical development strategy across starting materials, drug substance and drug product. This individual will play a critical role in preparing the company for clinical development and establishing an analytical control strategy that can evolve with the programs through later-stage development.

The ideal candidate is a scientifically rigorous, hands-on analytical development leader who has experience taking analytical methods from early development through method qualification/validation and GMP implementation. Experience with peptides, PEGylated molecules, other complex biologics/bioconjugates as well as particulates is highly desirable. Demonstrated ability to grow an Analytical Development organization as well as manage CRO/CDMOs is a plus.

This is an important leadership role in a small, fast-moving organization. The successful candidate will be comfortable operating strategically while also diving into experimental details, troubleshooting challenging analytical problems, and working closely with internal teams and external CRO/CDMO partners.