Senior Principal Scientist, Small Molecule Analytical & Control Strategy Development

Alexion's Synthetic Product Development (SPD) organization is seeking an experienced analytical and control strategy development leader. The Senior Principal Scientist, Analytical & Control Strategy Development, will own the delivering phase-appropriate control strategies for Alexion small molecule programs spanning preclinical development through first commercial launch.

You will be responsible for:

• Guiding the development, optimization, and validation of analytical methods for small molecule drug substances and drug products at CROs/CDMOs

• Proposing scientifically sound, phase-appropriate specifications for starting materials, synthetic intermediates, drug substances, and drug products

• Delivering phase-appropriate control strategies for Alexion small molecule programs, spanning preclinical development through first commercial launch

• Authoring and maintaining detailed Justification of Specification documents, ensuring that phase-appropriate maturation of the control strategy is documented throughout the development lifecycle

• Providing expert insight on topics including but not limited to ICH M7, ICH Q3D, ICH Q3C, and nitrosamine control strategies

• Technical review of release and stability data informing shelf life / retest

• Enable close-out of deviations, supporting cGMP manufacturing and batch disposition decisions

• Establish analytical methods in Alexion laboratories, supporting internal process development activities

• Delivering comprehensive strategies for impurity characterization and qualification

• Partnering with technical authorities across Alexion and AZ to formulate integrated and multidisciplinary commercial-stage control strategies for NDA/MAA

• Providing analytical control strategy expertise to enable Module 3 authoring of regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through NDA/MAA

• Authoring compelling responses to health authority queries on regulatory submission documents, and representing Alexion as a subject matter expert in meetings with health authorities

• Leading all aspects of reference standards qualification and management

• Providing subject matter expertise to support CDMO preparations for regulatory interactions including pre-approval inspections and audits

• Participating in business diligence activities as a technical SME, contributing to the assessment of potential acquisition / in-license opportunities

You will need to have:

• Ph.D. in analytical chemistry, bioanalytical chemistry, or a related field with minimum 12 years industry experience in analytical and control strategy development for small molecules

• Solid understanding of current regulatory guidelines and cGMP requirements pertaining to small molecules

• Strong experience in preparing regulatory submissions for small molecules and responding to inquiries from health authorities

• Proven record of leading sophisticated technical development projects, and remotely managing development timelines at CROs/CDMOs

• Technical expertise and intellectual curiosity to remain abreast of the latest developments pertaining to small molecule control strategy, and to proactively evaluate emerging technologies and regulatory trends

• Strong understanding of the design, development, optimization, and scale-up of small molecule manufacturing processes

• Up to 10% travel, with ability to work independently from remote locations

• Employees are required with or without an accommodation to 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 business hours.

• The duties of this role may also require work in a laboratory environment. Employees must, 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!

We would prefer for you to have:

• Experience with online process analytical techniques to accelerate development and enable enhanced control strategies for multi-step continuous manufacturing processes

• Experience with chemometrics, multivariate data analysis, in situ reaction monitoring and reaction profiling

• Experience in delivering phase-appropriate control strategies for synthetic peptides spanning clinical development through commercial launch, including Module 3 authoring for synthetic peptide NDA/MAA submissions and responses to health authority queries

Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.