Director/Senior Director, Formulation & Drug Delivery

About Anziva

Anziva Pharmaceuticals is a pharmaceutical development company focused on creating differentiated drug-delivery products from proven therapeutic agents. Our pipeline includes a targeted transdermal patch for knee pain, an advanced hydrogel for diabetic foot ulcers and wound care, and a long-acting implantable drug-delivery platform.

We are seeking an experienced formulation and drug-delivery scientist to join our growing team and take a hands-on leadership role in advancing these programs from formulation development through scale-up and manufacturing.

The Role

The Director/Senior Director, Formulation & Drug Delivery will lead the technical development of Anziva's drug-delivery programs, with an initial emphasis on topical and transdermal products.

This is a hands-on R&D leadership position. The successful candidate should be equally comfortable designing a development strategy, formulating products at the bench, analyzing experimental results, troubleshooting manufacturing challenges, and working with external development and manufacturing partners.

The position will work closely with the Founder & CEO and will have significant responsibility for translating early-stage concepts and formulations into scalable pharmaceutical products.

Key Responsibilities

• Lead formulation and product development for topical and transdermal drug-delivery systems, including transdermal patches, topical formulations, hydrogels and related dosage forms.
• Lead continued development and optimization of Anziva's targeted knee-pain transdermal patch.
• Design and execute formulation studies evaluating drug loading, permeation, adhesion, excipient selection, stability, release and overall product performance.
• Design, conduct and interpret in vitro permeation testing (IVPT) using Franz diffusion cells and relevant membrane/skin models.
• Develop a fundamental understanding of drug, excipient, adhesive and skin interactions affecting topical and transdermal delivery.
• Translate laboratory formulations into scalable manufacturing processes and support technology transfer to external manufacturing partners.
• Identify and troubleshoot formulation, processing, scale-up and manufacturing challenges.
• Develop and characterize hydrogels and other drug-delivery systems for wound-care applications.
• Contribute to development of additional drug-delivery platforms, including long-acting and implantable systems.
• Establish experimental plans, development timelines and technical milestones for assigned programs.
• Analyze and interpret analytical and formulation data and use results to guide product-development decisions.
• Perform and/or oversee analytical characterization including HPLC/UPLC, drug-content assays, release testing, stability studies and related pharmaceutical testing.
• Prepare technical reports, protocols, development summaries and documentation supporting regulatory and intellectual-property activities.
• Manage relationships and technical activities with CDMOs, CROs, material suppliers and other external development partners.
• Support preparation for scale-up, engineering batches, GMP manufacturing and eventual technology transfer.
• Help establish laboratory systems, equipment, SOPs and development processes as Anziva expands.
• Mentor and eventually supervise additional scientists and research associates as the R&D team grows.

Qualifications

Required

• PhD in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry or a related discipline.
• Approximately 7 years of relevant pharmaceutical product-development experience following the PhD, with flexibility for exceptional candidates.
• Strong experience in topical and/or transdermal formulation development.
• Experience developing transdermal patches, topical products, pressure-sensitive adhesive systems, hydrogels or related drug-delivery technologies.
• Strong understanding of formulation science, drug-excipient interactions, permeation and pharmaceutical product design.
• Hands-on experience with pharmaceutical formulation development and laboratory experimentation.
• Experience with IVPT/IVRT and Franz diffusion-cell methodologies.
• Experience with analytical techniques including HPLC/UPLC.
• Understanding of pharmaceutical manufacturing, process development, scale-up and technology transfer.
• Ability to independently design experiments, interpret results, troubleshoot problems and make development recommendations.
• Ability to operate effectively in a small, fast-moving pharmaceutical company where responsibilities extend beyond traditional functional boundaries.

Preferred

• Direct experience developing drug-in-adhesive transdermal patches or other complex topical delivery systems.
• Experience with pressure-sensitive adhesives, permeation enhancers and skin-delivery technologies.
• Experience taking pharmaceutical products from early formulation development through scale-up and GMP manufacturing.
• Experience working with pharmaceutical CDMOs and CROs.
• Experience with wound-care products, hydrogels or advanced biomaterials.
• Experience with biologics, peptides or delivery of macromolecules is a plus.
• Experience supporting CMC/regulatory development for pharmaceutical products is a plus.

Ideal Candidate

We are looking for someone who combines the scientific depth of an experienced formulation scientist with the ownership mentality of an early-stage pharmaceutical leader.

This person should not simply manage projects from a desk. They should be willing to design experiments, work in the laboratory, solve formulation and manufacturing problems, work directly with external partners, and take ownership of moving programs forward.

As Anziva grows, this position has the potential to develop into a broader R&D leadership role.

One thing I would emphasize in recruiting is that you're not looking for a generic formulation scientist. The highest-value candidate is someone who has actually developed commercially relevant topical/transdermal products and understands adhesives, permeation, formulation, processing, scale-up, and manufacturing. Someone with 15 publications but little product-development experience would be considerably less useful to you than someone who has spent 8–12 years actually getting patches/topicals through development.

And because Anziva's model is lean development followed by partnering/licensing rather than building a huge commercial organization, I'd prioritize someone who has managed CDMOs and tech transfer almost as highly as their bench skills.