Director, Injectable Drug Product Development,
About The Position
Formulation and process development, product integration, and manufacturing of patient-centered, unique injectable drug products for Alexion's diverse portfolio from pre-clinical to successful licensure. Lead interface with Operations, CMC Project management, Clinical Development, Regulatory on life cycle management opportunities. Develop drug product delivery strategies through internal/external partnerships and product integration into drug/device combination products. Alexion enables the department to progress its diverse portfolio. This portfolio spans peptide, nucleic acid, protein-based modalities, as well as modalities for gene delivery. People present these modalities in multiple forms, including liquid and lyophilized dosage forms in vial, prefilled syringe, and cartridge-based presentations. Ensure tech transfer of Alexion's portfolio with specialized input on engineering solutions for equipment and processes. Review and develop drug product techology roadmap and manage important investments. Assist and mentor colleagues in a matrix team for efficient and successful drug product development and manufacturing in a phase appropriate manner. Partner with functions across Alexion to build the best strategies for developing products in Alexion's diverse portfolio. Provide subject matter expertise for preparing 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 partners in Operations, Regulatory Affairs, and Commercial organizations. Devote considerable time and effort in developing colleagues and the requisite to achieve Alexion's growing R&D pipeline.
Requirements
- Must have a BS or equivalent in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with relevant experience
- You have number of years of drug product development experience in formulation and process development and technology transfer for mAbs, proteins, peptides. synthetics and genomic medicine products
- At least 8 years of experience of direct experience developing approaches to allow drug product development for early and late-stage programs through licensure.
- At least 5 years of experience managing a team of scientists and engineers at different levels (directly or in a matrix team) Ensuring their career growth.
- Must be proficient in current approaches for formulation and drug product process development, manufacturing processes and equipment, and applying these to developing efficient approaches to ensure product licensure.
- Knowledge of high concentration protein formulation development, aseptic processes, to provide vial, prefilled syringe, cartridge presentations as liquid and lyophilization dosage forms is important.
- Knowledge of current regulatory guidelines and cGMP requirements is necessary
Responsibilities
- Formulation and process development, product integration, and manufacturing of patient-centered, unique injectable drug products for Alexion's diverse portfolio from pre-clinical to successful licensure.
- Lead interface with Operations, CMC Project management, Clinical Development, Regulatory on life cycle management opportunities.
- Develop drug product delivery strategies through internal/external partnerships and product integration into drug/device combination products.
- Ensure tech transfer of Alexion's portfolio with specialized input on engineering solutions for equipment and processes.
- Review and develop drug product techology roadmap and manage important investments.
- Assist and mentor colleagues in a matrix team for efficient and successful drug product development and manufacturing in a phase appropriate manner.
- Partner with functions across Alexion to build the best strategies for developing products in Alexion's diverse portfolio.
- Provide subject matter expertise for preparing 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 partners in Operations, Regulatory Affairs, and Commercial organizations.
- Devote considerable time and effort in developing colleagues and the requisite to achieve Alexion's growing R&D pipeline.
Benefits
- A qualified retirement program [401(k) plan]
- Paid vacation, holidays, and paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans.
- Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
1,001-5,000 employees
