Senior Process Engineer, Downstream Process Characterization & Commercialization

Introduction to role

Are you ready to make a significant impact in the field of viral vector programs We are looking for a motivated Senior Process Engineer to join our team and support downstream process characterization and commercialization activities.

In this role youll be at the forefront of process characterization PPQ readiness BLA-enabling studies and technology transfer to both internal and external manufacturing sites. Your focus will be on downstream unit operations such as clarification chromatography filtration concentration and formulation. If you have hands-on experience in downstream process development or manufacturing and possess strong technical depth this is the opportunity for you!

NOTE: Up to 25% domestic and international travel required.

Accountabilities:

Downstream Process Characterization & Validation

• Design implement and support process characterization studies (DOE multivariate studies scaling assessments) for all downstream unit operations.

• Perform data analysis author technical reports and present study outcomes to cross-functional teams.

• Support development and refinement of control strategies CPP/ CQA linkages and process validation approaches.

• Conduct batch record review deviation evaluation and data trending to ensure process robustness.

• Apply AI-enabled tools and digital analytics to accelerate data review trend analysis batch record evaluation and process understanding driving faster and more consistent decision-making during late-stage development.

• PPQ Tech Transfer & Manufacturing Readiness

• Contribute to PPQ planning readiness execution and documentation for downstream processes.

• Participate in technology transfer to internal manufacturing facilities and CDMOs; support fit-for-purpose assessments and alignment on process parameters and acceptance criteria.

• Provide on-the-floor technical support during scale-up engineering runs PPQ batches and commercial campaigns (including off-shift support when required).

• Support raw material assessments process risk evaluations and comparability studies across facilities.

Regulatory Support

• Contribute to authoring and reviewing CMC content including:

• Process descriptions

• Characterization summaries

• PPQ protocols and reports

• Comparability justifications

• Control strategy elements

• Assist with preparation of BLA/MAA submission documents and responses to regulatory questions.

• Cross-Functional Collaboration

• Work closely with upstream fill-finish analytical sciences quality regulatory and manufacturing partners to ensure technical alignment.

• Represent downstream characterization activities in technical meetings and governance discussions.

• Support lifecycle management post-approval changes and process optimization initiatives.

Essential Skills/Experience:

• Ph.D. in Chemical Engineering Biochemical Engineering Biotechnology or related field (2 years industry experience); OR M.S. with 5 years of experience; OR B.S. with 7 years of hands-on industry experience.

• Experience with downstream bioprocess unit operations preferably in viral vector.

• Experience with late-stage development PPQ principles and process characterization approaches.

• Demonstrated proficiency in employing AI tools and digital solutions (e.g. data extraction document drafting analysis workflow automation) to enhance efficiency and accuracy with the ability to quickly adopt and integrate new AI technologies into daily work.

• Practical experience with GMP environments batch record execution or review deviations and investigations.

• Strong technical writing skills and experience with structured data analysis.

• Desirable Skills/Experience

• Experience supporting late-stage viral vector programs (lentiviral AAV adenoviral VLPs etc.).

• Experience with DOE design and execution and multivariate data analysis tools.

• Experience supporting BLA/MAA filings or contributing to CMC sections.

• Knowledge of control strategy development and risk assessment tools (e.g. FMEA).

• Formal training or certification in AI digital analytics or automation tools demonstrating the ability to apply current digital solutions to process development data analysis and documentation workflow.

The annual base pay for this position ranges from $103286.40 - $154929.60. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. 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 pay (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.

At AstraZeneca we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration and problem-solving as we strive to deliver life-changing medicines. We embrace challenges in rapidly changing markets by continuously seeking better ways to deliver medicines to patients. Our team is diverse and connected globally working together to push the boundaries of supply chain excellence. With a focus on sustainability and a commitment to doing things the right way we offer opportunities for growth and development in a supportive environment.

Join us in making a differenceapply today!

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.