Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

***Hybrid means on-site 3 days a week***

This is what you will do:

Alexion’s Product Development and Clinical Supply (PDCS) organization is seeking an experienced preformulation scientist to lead early-phase oral solid dosage (OSD) drug product development. The Principal Scientist, Oral Solid Dosage Drug Product, will possess strong technical knowledge of physicochemical and solid state properties, deep understanding of formulation design, and preeminent expertise in deciphering biopharmaceutical behavior.

You will be responsible for:

• Leveraging expertise of Alexion technical SMEs coupled with external CMOs to drive execution of OSD preformulation and formulation design strategies with a strong focus on preclinical studies through first human dose.
• Collaborating with biologists, medicinal chemists, and pharmacokinetic scientists to support preformulation assessment and screening of small molecules, and formulation design for non-clinical pharmacology studies.
• Formulating new chemical entities (NCEs) using advanced technologies including amorphous solid dispersions.
• Design and lead execution of lab-based experimental work, delivering key technical understanding and enabling aggressive program timelines.
• Ensuring that stage-appropriate levels of formulation and process knowledge are maintained and documented throughout development.
• Providing technical expertise to enable authoring of drug product modules for regulatory submission (IND/IMPD) documents that convey phase-appropriate scientific understanding.

You will need to have:

• Ph.D. in Pharmaceutical Sciences or Chemical Engineering with minimum of 8 years industrial experience in preformulation of OSD drug products.
• Intimate familiarity with methods to characterize physicochemical and solid state properties of NCEs, in order to optimize formulation design.
• Demonstrated expertise in developing pre-formulation and early formulations for pre-clinical evaluations such as toxicity/exposure, efficacy, and pharmacokinetic studies in OSD to enable FIH.
• Expertise in in vitro assessment of biopharmaceutical performance to facilitate formulation selection.
• Expertise in analytical techniques, such as HPLC/UPLC, PXRD, TGA, DSC, DVS
• Working knowledge and experience of pharmaceuticals in pre-development and early development in preparation for regulatory submission documents.
• Ability to plan complex technical development projects.
• Ability to execute, document, analyze, and share key findings from lab-based experimental work.
• Ability to remotely manage preformulation design and development activities and timelines at CROs.
• Motivation to remain abreast of scientific and regulatory trends regarding enhancement of bioavailability for poorly-soluble drug substances and evaluate new and emerging formulation and manufacturing technologies.
• Up to 15% travel, with ability to work independently from remote locations.
• The duties of this role may require periodic work in a laboratory or manufacturing environment. As is typical of such roles, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around hazardous materials; gown/degown PPE; 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.

We would prefer for you to have:

• Knowledge of thermodynamic models used to predict and describe the phase behavior of amorphous solid dispersions.
• Technical expertise in the use of amorphous solid dispersion to enhance bioavailability of poorly-soluble drug substances.
• Expertise in the design of formulations for modified release drug products.
• Experience in design and build-out of drug product development laboratories.
• Experience in process analytical technologies/spectroscopic techniques.
• Experience in multivariate data analysis.

#LI-SM1

#LI-Onsite

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. 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.

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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers 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, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.