This is what you will do:
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, nucleic acid 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 products The position will work with the department head to assess appropriate drug product development and delivery strategies via internal and external partnerships, managing the budget and internal resources for the development of clinical and commercial phase drug products. The ideal candidate will also enable the development of phase-appropriate regulatory strategies and products. 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.
You will be responsible for:
You will need to have:
- 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.
- Enables the department by developing expertise in one or more areas; enable progressing Alexion's diverse portfolio spanning peptide, nucleic acid, protein-based modalities, modalities for gene delivery as liquid & lyophilized dosage forms in vial, prefilled syringe, and cartridge-based presentations.
- Participates in developing 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.
- Works with the tech transfer organization and develops strategies for process characterization and process validation studies for late-stage programs to enable robust commercial manufacturing processes.
- Provide subject matter expertise for regulatory interactions including inspections, audits and is accountable for the technical content of drug product sections of regulatory submissions.
- Work on drug product development strategies within PDCS and with key stakeholders in Research, Alexion Operations, Clinical Development, Regulatory Affairs, Quality, and VISion and Commercial organizations.
- Devote significant time and effort in developing colleagues and the requisite bench strength to deliver on Alexion's growing R&D pipeline.
We would prefer for you to have:
- The successful candidate will have substantial years of injectable drug product development experience with 8+ years of experience leading drug product development teams/function with direct experience in mAbs, proteins and preferably in peptides, synthetics, and the modalities for gene therapy
- At least 5 years of experience in managing a group of drug product development scientists or engineers with direct experience of developing early as well as late-stage programs through licensure
- 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.
- Direct experience in preparing regulatory submissions including BLA/MAAs and engaging with regulatory inquiries is required.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- Must have a BS/MS/PhD or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related discipline with relevant experience
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
This job has expired.