Director, Formulation and Process Development

BioCT Innovation Commons; New Haven (CT); Hybrid; USD 180,000 - 280,000; Full time

Job summary

AstraZeneca in New Haven region is seeking a Director, Formulation and Process Development to lead injectable drug product development from preclinical to licensure across biologics, peptides, and gene delivery modalities.

You will mentor scientists and engineers, build cross‑functional networks with product development, clinical supply, operations, quality, and regulatory, and steer technology transfers that accelerate time to patients. Hybrid work with office focus.

Qualifications

• BS or equivalent in a relevant field with meaningful experience.
• 8 years of experience leading a group of drug product development scientists or engineers for injectable programs.
• 5 years of team leadership in a matrix structure with career development focus.
• Proficiency in formulation and drug product process development and regulatory expectations.
• Knowledge of high‑concentration protein formulation, aseptic processes, and delivery presentations.
• Knowledge of regulatory guidelines and cGMP requirements.

Responsibilities

• Lead end‑to‑End Injectable Development for liquid and lyophilized injectables from preclinical to licensure.
• Define drug product strategies across biologics, peptides, nucleic acids, and delivery modalities.
• Enable high‑concentration proteins and other modalities with stability and manufacturability focus.
• Drive tech transfer with fit‑for‑purpose engineering solutions and external partnerships.
• Lead the injectable drug product technology roadmap and prioritise critical investments.
• Mentor scientists and engineers; build matrixed teams delivering at pace.
• Collaborate across development, operations, regulatory, and quality to align product strategy.

Skills

Leadership

Strategic thinking

Cross-functional collaboration

Regulatory knowledge

Project management

Education

BS or equivalent in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related field

Job description

Are you ready to lead science and engineering that turn breakthrough molecules into reliable, patient-centered injectable medicines? Want to shape how complex biologics, peptides, and genomic medicines are formulated, manufactured, and delivered worldwide?

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.

Accountabilities

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

Essential Skills/Experience

• 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.

Desirable Skills/Experience

• 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.

When we put unexpected teams in the same room, we spark ambitious thinking with the power to inspire life‑changing medicines. In‑person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.

Why AstraZeneca

Harness the energy of a fast‑paced biotech environment with the reach and investment of a global organization. We bring unexpected teams together to solve hard problems in injectable drug product science—advancing groundbreaking modalities, modernizing aseptic manufacturing, and shaping drug‑device combinations that make treatment simpler for patients. We value patience alongside ambition, backing bold ideas with real resources, tailored development, and leaders who empower you to ask sharp questions, take smart risks, and translate data into decisive action that changes lives.

If you are ready to define the technology, teams, and standards that deliver reliable injectables to patients faster, step forward and start the conversation today!

Date Posted 17-Jul-2026

Closing Date 30-Aug-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.