Scientist I, Injectables Drug Product Development

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.

Position Summary

In this role the candidate will research, design and execute scientific studies to enable the drug product (DP) process development, characterization, and commercial validation of parenteral/injectable biologic products. The candidate will support the development of a variety of manufacturing unit operations including, but not limited to, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. Hands‑on experience with biotherapeutics drug product development, including a detailed understanding of the manufacturing unit operations is desirable. A general understanding of protein chemistry, formulation, and biopharmaceutical assay (e.g. HPLC, CE, iCE, HIAC, MFI, etc.) development as well as the ability to run biopharmaceutical assays in a laboratory is preferred.

The candidate will also be responsible for manufacturing technology transfer activities, including but not limited to sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as at-scale/full scale process development studies, protocols, and reports. Experience with supporting deviations, change controls, and CAPAs utilizing electronic Quality system such as Trackwise is a plus.

In addition, the candidate will provide clinical and commercial manufacturing site support including but not limited to weekly/biweekly support meetings, action item owner, and as necessary in-person on-site manufacturing support. This position is expected to interact regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs.

Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, and Adobe Pro, would be an advantage.

Responsibilities

• Independently designs and executes development studies for Alexion pharmaceuticals’ drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sites
• With minimal supervision may lead elements of projects with multiple cross functional stakeholders, as well as understand the cross functional implication of project activities and decisions.
• Can prioritize multiple assigned tasks and projects and may lead a project team consisting of one or more junior team members. The ability to work independently as well as part of the team is essential.
• Performed in depth data analysis as well as authors technical reports and or relevant sections of clinical and commercial regulatory filings on the executed studies for the Alexion drug product candidates
• Be current with the literature about drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations
• Actively participate in department and team meetings including assuming ownership and delivering on assign action items.
• Develop presentations for meetings with internal and external stakeholders with some minimal supervision.

Requirements

• PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 0-2 years, a MS with 8 years or BS with 10 years of relevant experience. Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred.
• Scientific and practical knowledge of protein biochemistry, protein formulation/stability, as well as biotherapeutic drug product process development is essential.
• Hands-on experience with defining processes, scale up, transferring information between development and manufacturing sites, document preparation, as well as knowledge of cGMP and Quality expectations is desirable.
• Previous experience in biotherapeutics development as well as understanding of the biotechnology products life cycle
• Understanding of the biotherapeutics drug formulation development and analytical tools used to test formulations is a plus.
• Ability to take initiative in problem solving and finding solutions to scientific challenges is preferred.
• The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential.
• Excellent interpersonal skills are required, as is the strong ability to communicate effectively.
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, 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 biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging

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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.