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Alexion Pharmaceuticals Director, Injectable Drug Product Development in New Haven, Connecticut
This is a hybrid position with the expectation of being onsite 3 or more days a week at our New Haven, CT location.
The position leads and directs the technology transfer, manufacturing support and validation of 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 will be the ultimate manufacturing of drug product which needs to be developed as drug and/or drug/device combination product. The position will work with the Sr. Director of Drug Product Process Development and Technology Transfer to optimize the drug product technology transfer and manufacturing support for internal and external manufacturing sites, as well as managing the required internal resources and budgets. The ideal candidate will also enable the development and implementation of phase-appropriate technical approaches that are aligned with regulatory expectations. The position will be a senior member of the Injectable Drug Product Development department and will need to collaborate and network with other departments within Product Development and Clinical Supplies (PDCS) as well as with Global Operations, Quality and Regulatory organizations.
Job Duties & Responsibilities
Oversees and directs the process development, technology transfer, manufacturing support and process validation of patient-centered, injectable drug products for Alexion’s portfolio from pre-clinical to successful global commercial licensure.
Responsible for phase appropriate process development, characterization, and validation of injectable drug product processes, such as bulk freeze / thaw, compounding / mixing, bulk and sterile filtration, vial / syringe / cartridge filling, visual inspection, as well as lyophilization, as necessary.
Enables the department by developing expertise in one or more areas around process development and manufacturing Alexion’s diverse portfolio spanning synthetic, peptide, nucleic acid, and protein-based modalities across various liquid & lyophilized, vial, preﬁlled syringe, and cartridge-based presentations.
Leads the development of strategies for the overall process validation approach including but not limited to process risk assessments, process control strategies, technology transfer plans / reports, sterile filter validation, and process performance qualiﬁcation for late stage programs to ensure robust commercial drug product manufacturing processes.
Assist and mentor colleagues in the execution of efﬁcient and successful phase appropriate technology transfers of Drug Products to internal and external manufacturing organizations. May directly provide hands on support to the process development and characterization activities, as needed, while assisting and mentoring colleagues.
Led or mentor colleagues in manufacturing support for process deviations, ownership of technology transfer and process improvement change controls, as well as process related CAPAs.
Creates network within and outside Alexion with manufacturing related SMEs to enable development of best in class process development, characterization, and manufacturing approaches / technologies
Provide subject matter expertise for the preparation of global regulatory ﬁlings, regulatory interactions including inspections, audits and is responsible for the technical content of the relevant drug product sections of regulatory submissions.
Works with the Sr. Director of Process Development and Technology Transfer on the development on drug product development strategies within PDCS and with key stakeholders in Global Operations, Global 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.
The successful candidate will have 8+ years of drug product development experience with direct experience in technology transfer and manufacturing support for mAbs, proteins, peptides, and/or synthetic injectable products.
At least 3-4+ years of experience in managing drug product development scientists or engineers with to enable drug product process development and manufacturing support for early as well as late-stage programs through licensure.
Must be proﬁcient in scale-up/scale-down approaches in process characterization and applying these to developing and executing process validation strategies to enable robust commercial manufacturing processes. Strong established expertise in developing aseptic processes for preﬁlled syringe, cartridge and vial based liquid and lyophilized products is required. Knowledge of current global regulatory guidelines and cGMP requirements is essential. Experience in manufacture of high- concentration protein-based dosage forms is desired.
Experience in preparing global regulatory submissions including BLA/MAAs and engaging with regulatory inquiries is highly desirable.
Must have a MS/PhD or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related discipline.
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.