Principal Scientist

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.

This is what you will do:

Alexion’s Product Development and Clinical Supply (PDCS) organization is seeking an experienced organic chemist to serve as drug substance technical lead in support of an emerging small molecule portfolio.

The Principal Scientist, Synthetic Process Development, will leverage deep chemistry expertise to design safe, scalable, and robust synthetic routes, and provide technical leadership for process validation, regulatory submission, and preapproval inspection, culminating in successful product launch.

Responsibilities include delivering a comprehensive strategy for design and development of drug substance manufacturing processes, articulating timeline and resource requirements to Alexion management, providing technical leadership for third-party development, manufacturing, and process validation activities, and authoring regulatory submission documents.

You will be responsible for:
Leveraging expertise of Alexion technical SMEs coupled with external CMOs to drive execution of technical development plans spanning preclinical studies through process validation and NDA/MAA submission and approval.

Ensuring technical readiness of CMOs for process validation, pre-approval inspection, and commercial launch.

Providing in-plant technical support during process validation and pre-approval inspection, and as needed at earlier stages of development.

Providing technical expertise to enable authoring of drug substance modules for regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through NDA/MAA.

Partnering with drug product and analytical development technical experts to formulate integrated and holistic CMC control strategies for NDA/MAA, consistent with Quality by Design expectations.

Providing expert insights on topics including but not limited to regulatory starting material (RSM) designation, ICH M7 and ICH Q3D control strategy, and process optimization / process redesign strategies to improve COGS.

You will need to have:
Ph.D.

in organic chemistry with minimum 10 years post-doctoral experience and minimum 7 years experience in the pharmaceutical industry.

Deep understanding of the design, development, optimization, and tech transfer of small molecule drug substance manufacturing processes.

Late-phase development experience including process validation, authoring of NDA/MAA CMC sections, and technical support of pre-approval inspections.

Intimate familiarity with cGMPs and pharmaceutical regulatory guidance.

Ability to plan and oversee execution of process design and development activities at third party service providers.

Technical expert who will remain abreast of scientific and regulatory trends pertaining to small molecules, peptides, and oligonucleotides, and who will evaluate new and emerging chemistry and process 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:
Prior experience in chemometrics,