About the position
The position leads and directs the formulation and process development, product integration, and manufacturing of patient-centered injectable drug products for Alexion’s diverse portfolio spanning synthetic, peptide, genomic medicine, and protein-based modalities across various liquid, lyophilized, vial, prefilled and cartridge-based presentations. A key focus area would be on the successful product integration into drug/device combination product. The position will also enable the assessment of early candidates in development, utilize appropriate analytical tools to enable candidate nomination and utilize strategies and technologies via internal and external partnerships. The ideal candidate will also enable the development of portfolio projects in a phase-appropriate manner while managing the budget and internal resources. The position will be a member of the Injectable Drug Product Management team and will need to collaborate and network with other departments within Product Development and Clinical Supplies (PDCS) as well as with Research, Alexion Operations, Clinical Development, Quality and Regulatory organizations.
Responsibilities
- Direct formulation and process development, product integration, and manufacturing of patient-centered, differentiated injectable drug products for Alexion’s diverse portfolio from pre-clinical to successful licensure.
- Lead interface with research on candidate assessments utilizing current as well as developing new tools (e.g., in silico related, biophysical, AI based) and approaches to enable appropriate candidate selection for development.
- Enable the development of drug product development and delivery strategies through internal/external partnerships as well as product integration into drug/device combination products.
- Assist and mentor colleagues for efficient and successful development and technology transfers of Drug Products to internal and external manufacturing organizations in a phase appropriate manner.
- Partner with functions across Alexion with key focus on Research, Analytical Development to build the best-in-class approaches and strategies for developing products in Alexion’s diverse portfolio.
- Provide subject matter expertise for the preparation of regulatory filings, regulatory interactions including inspections, audits and is accountable for the technical content of the relevant drug product sections of regulatory submissions.
- Work with the Head on the development on drug product development strategies within PDCS and with key stakeholders in Global Operations, Global Regulatory Affairs, and Commercial organizations.
- Devote considerable time and effort in developing colleagues and the requisite bench strength to deliver on Alexion’s growing R&D pipeline.
Requirements
- BS or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related discipline with relevant experience.
- At least 8 years of experience in managing a group of drug product development scientists or engineers with direct experience of developing processes to enable drug product manufacturing for early as well as late-stage programs through licensure.
- At least 5 years of experience in managing a team of scientists and engineers at different levels enabling their career growth and development.
- Must be proficient in current approaches for candidate assessment, formulation and process development, process characterization and applying these to developing efficient and robust approaches to enable product licensure.
- Deep knowledge of high concentration protein formulation development, aseptic processes, to provide vial, prefilled syringe, cartridge presentations as liquid and lyophilization dosage forms is essential.
- Knowledge of current regulatory guidelines and cGMP requirements is essential.
Nice-to-haves
- MS/PhD or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related discipline with relevant experience.
Benefits
- In-person working gives us the platform we need to connect, work at pace and challenge perceptions.
- We balance the expectation of being in the office while respecting individual flexibility.
- Commitment to transparency, objectivity, and ethics drives us to meet unmet medical needs.
- A commitment to lifelong learning, growth and development for all.
