Associate Scientist III, Synthetic Drug Substance Process Development
AstraZeneca

Job Info

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This is what you will do:
Alexion's Synthetic Product Development (SPD) organization is seeking a synthetic organic chemist to expand our process development capabilities in support of an emerging small molecule and synthetic peptide portfolio. The Scientist, Synthetic Drug Substance Development, will couple strong laboratory skills with experience in synthetic route design and process scale-up. Laboratory responsibilities will include execution of sound experimental plans in support of route scouting, process development, and process characterization activities.

You will be responsible for:
• Design and execute route scouting studies to enable selection of safe, scalable, and cost efficient synthetic routes to drug substances, key intermediates, and regulatory starting materials.
• Develop, optimize, and execute robust chemical process experiments in support of a portfolio of small molecules and synthetic peptides.
• Synthesize impurities (on the order of 100 milligrams to 10 grams) to support analytical method development, and quantitative impurity fate and purge spiking studies.
• Participate in the design and deployment of continuous manufacturing equipment and support development of continuous chemical processes.
• Develop technical expertise in the operation of advanced laboratory equipment, and partner with supporting functions to ensure smooth lab operations.
• Draft technical reports supporting regulatory submissions, and provide technical insights to enable responses to queries from regulatory agencies.

You will need to have:
• B.S. in Organic Chemistry OR related discipline with a minimum of 4 years of experience in the biopharma industry (or M.S. with minimum 3 years industrial experience).
• Strong laboratory skills and keen desire to grow as a research scientist in the lab.
• Solid understanding of the design, development, and scale-up of small molecule drug substance manufacturing processes.
• Understanding of cGMP principles and regulatory guidances.
• Understanding of Quality by Design (QbD) principles.
• Technical expert who will remain abreast of the latest scientific and regulatory trends pertaining to the synthesis of small molecules and synthetic peptides.
• Strong work ethic and ability to work effectively both independently and as part of a team.
• Excellent written and verbal communication skills.
• Up to 10% travel, with ability to work independently from remote locations.
• The duties of this role are conducted in an 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/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:
• Firsthand experience in data-rich experimentation and laboratory automation
• Firsthand experience with strategic incorporation of biocatalysis, photochemistry, and/or electrochemistry into pharmaceutical route design
• Firsthand experience in development of robust and efficient analytical methods for rapid on-line process monitoring and/or high-throughput process screening and optimization
• Firsthand experience with the design and development of flow chemistry processes

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 is why we work, on average, a minimum of four days per week from the office. But that does not mean we are not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $87,200 to $130,800.
However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.

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