Director, Formulation and Process Development

AstraZeneca•New Haven, CT

7d•Onsite

About The Position

The Director, Formulation and Process Development, will set the strategy and steer execution for injectable drug products across multiple modalities and presentations, from preclinical through successful licensure. Your work will drive how life-changing therapies reach people with serious and rare conditions, ensuring products are robust, manufacturable, and ready for global scale-up. You will lead a high-performing team, build strong technical networks inside and outside the company, and guide technology transfers that accelerate time to patients. This role sits at the intersection of science, engineering, and delivery! Partner closely with colleagues in product development, clinical supply, operations, quality, and regulatory to design phase-appropriate solutions, integrate devices and combination products, and shape the technology roadmap that underpins our injectable portfolio.

Requirements

BS or equivalent in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related field with meaningful experience
8 years of experience in leading a group of drug product development scientists or engineers with end-to-end drug product development experience (spanning formulation, process development, quality attribute assessment, tech transfer and manufacturing support) for mAbs, fusion proteins, injectable peptides/synthetics programs.
5 years of experience leading a team of scientists and engineers at different levels (directly or in a matrix team) and ensuring their career growth.
Proficient in current approaches for formulation and drug product process development, manufacturing processes and equipment, regulatory expectations and applying these to developing efficient approaches to ensure product licensure.
Knowledge of high concentration protein formulation development, aseptic processes, vial, prefilled syringe, cartridge presentations, liquid and lyophilization dosage forms is meaningful.
Knowledge of current regulatory guidelines and cGMP requirements is necessary

Nice To Haves

Experience with drug-device combination products and human factors considerations for injectables.
Expertise in lyophilization cycle development, scale-up, and aseptic fill-finish operations.
Demonstrated application of QbD, PAT, and advanced analytics to define and control critical quality attributes.
Leadership of global CMC teams and authorship of BLA/MAA drug product sections.
Proven success leading CDMOs/CMOs and complex external partnerships.
Background in rare or specialty disease programs and accelerated development pathways.

Responsibilities

Lead formulation and process development for liquid and lyophilized injectables in vials, prefilled syringes, and cartridges, advancing programs from preclinical to commercial licensure.
Define drug product strategies across biologics, peptides, nucleic acids, and gene delivery modalities, including integration with combination products and delivery devices.
Enable high-concentration proteins and other meaningful modalities, optimizing stability, manufacturability, and patient usability across multiple formats.
Drive phase-appropriate tech transfer with fit-for-purpose engineering solutions for equipment, processes, and scale, collaborating with internal teams and external partners.
Lead the injectable drug product technology roadmap; evaluate and prioritize critical investments that unlock capability, quality, and speed.
Mentor and develop scientists and engineers at multiple levels; build and lead matrixed teams that deliver reliably at pace.
Work with development, operations, regulatory, and commercial partners to craft product and supply strategies that connect patient needs to technical and business outcomes.
Serve as authority for regulatory filings and interactions; ensure the technical integrity of drug product sections and inspection readiness.
Ensure plans, resources, and budgets are aligned to program phase and risk; own delivery and resolve issues to keep achievements on track.