Associate Scientist II, Injectable Drug Product Development

Alexion; New Haven (CT); On-site; USD 150,000 - 210,000; Full time

Job summary

Alexion seeks a Senior Scientist to lead drug product development for parenteral biologics, guiding DS/DP processes from scale-up through commercial validation. You will manage cross-functional teams, design development studies, and drive technology transfer across sites.

Strong expertise in protein biochemistry and biopharmaceutical assays is essential. The role involves collaboration with Analytical Development, Quality, CMC, and Regulatory Affairs, with on-site laboratory work and rigorous

Qualifications

• PhD with a minimum of 2+ years' relevant research experience or MS with 11+ years, BS with 12+ years is acceptable.
• Hands-on experience in biotherapeutics drug product development and related manufacturing unit operations.
• Knowledge of cGMP and Quality expectations; experience with electronic QA systems is a plus.

Responsibilities

• Lead drug product development teams with multiple cross-functional stakeholders.
• Design and execute development studies for internal and contract manufacturing sites.
• Coordinate technology transfer activities and ensure timely completion of studies and reports.
• Analyze data and author technical reports for regulatory filings or internal documentation.
• Stay current with literature on drug product manufacturing and regulatory expectations.
• Prepare presentations for internal and external stakeholders and lead meetings.

Skills

Leadership

Cross-functional coordination

Data analysis

Technical writing

Effective communication

Education

PhD in Chemistry/Biochemistry/Biophysics/Chemical Engineering

MS in a related field

BS with 12+ years of relevant experience

Tools

EndNote

JMP

GraphPad

Excel

PowerPoint

Job description

This is what you will do:

In this Senior Scientist role, the candidate will lead the 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 lead 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 required. An 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 necessary.

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 Corrective Actions/Preventive Actions utilizing electronic Quality system such as Vault Enterprise Quality Vault (EQV) is desirable.

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 Development & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, CMC, 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, JMP, Visio, and Adobe Pro, would be an advantage.

You will be responsible for:

• Leading drug product development teams with multiple cross functional stakeholders, as well as understanding the cross functional implication of project activities and decisions. Making scientific/technical proposals based on corporate or project objectives.
• Independently designing and executing development studies for Alexion pharmaceuticals’ drug candidates and commercial products, supporting technology transfer activities for internal manufacturing and contract manufacturing sites
• Understanding 'big pictures' for projects and tasks involved and prioritizing work of self and others accordingly. Prioritizing multiple assigned tasks and projects and leading project teams comprising of one or more junior team members. The ability to work independently as well as part of the team is essential.
• Performing in depth data analysis as well as authoring 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.
• Communicating effectively with peers and management. Actively participating in department and team meetings including assuming ownership and delivering on assigned action items.
• Developing presentations for meetings with internal and external stakeholders with minimal supervision.

You will need to have:

• PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 2+ years, a MS with 11+ years or BS with 12+ years of relevant experience.
• 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 knowledgeable in cGMP and Quality expectations.
• Experience in biotherapeutics development as well as understanding of the biotechnology products life cycle
• 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 roleare 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

We would prefer for you to have:

• Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred.
• Background in solid-state formulation development

• Understanding of the biotherapeutics drug formulation development and analytical tools used to test formulations is a plus.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.