AstraZeneca
Senior Process Engineer, Viral Vector, Downstream
AstraZeneca, Gaithersburg, Maryland, us, 20883
AstraZeneca is looking for a highly motivated and experienced Senior Process Engineer, Viral Vector, for downstream process development. The candidate will play a critical role in building and leading a high-performing team that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio. You will design, execute, and optimize scalable Lentiviral Vector (LVV) downstream purification processes with a primary focus on clinical and commercial scales. You will contribute hands‑on to experimental design, process characterization, and scale‑up/tech transfer activities from research through IND enabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs. This position is based in Gaithersburg, MD.
Key Responsibilities
Downstream Process Development:
Plan and perform experiments to develop scalable, cost‑effective LVV purification processes for ex vivo and in vivo applications, targeting yield, purity, potency, and consistency.
Unit Operations Execution:
Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation/fill‑related steps; define phase‑appropriate in‑process controls and operating ranges.
Process Characterization & Data Analysis:
Design and analyze studies (including DOE) to identify CPPs/CMAs, establish design space, and justify control strategies; trend performance, conduct troubleshooting and root‑cause analysis, and recommend corrective actions.
Scale‑Up, Scale‑Down & Tech Transfer Support:
Develop representative scale‑down models; support scale‑up to pilot, clinical, and commercial‑relevant equipment; prepare technical transfer documents and assist transfers to internal GMP sites and CDMOs.
Novel Technologies & Continuous Improvement:
Evaluate and implement next‑generation purification technologies and consumables to improve efficiency, robustness, and product quality; contribute to continuous improvement initiatives.
Documentation & Compliance:
Author high‑quality protocols, reports, batch records, and development summaries; support drafting of CMC content for regulatory submissions (e.g., IND) and align practices with cGMP and Quality systems expectations.
Cross‑Functional Collaboration:
Partner with upstream PD and Analytical Development to link process parameters with product quality attributes (e.g., titer, infectivity/potency, residuals/impurities); collaborate with Manufacturing and Quality on operational feasibility and compliance.
Qualifications
Education:
PhD in Biochemical/Chemical Engineering, Biotechnology, or related field with 2–5 years of relevant industry experience; or MS with 5–8 years; or BS with 8–10 years. Cell and gene therapy experience preferred. Title will be commensurate with qualifications and experience.
Experience:
Hands‑on downstream process development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale considerations and tech transfer.
Technical Expertise:
Practical proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation; understanding of viral vector‑specific impurity profiles (host cell proteins/DNA, process residuals) and strategies to control them.
Data & Risk Tools:
Working knowledge of statistical analysis and DOE; familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification.
GMP & Regulatory:
Understanding of cGMP and Quality systems; familiarity with FDA/EMA guidance relevant to gene and cell therapy; experience contributing to CMC sections of regulatory filings is a plus.
Communication & Collaboration:
Strong written and verbal communication; ability to work effectively in cross‑functional, matrixed teams; demonstrated problem‑solving and troubleshooting skills.
Preferred Qualifications
Experience scaling LVV or other viral vector/biologic purification processes from preclinical to clinical/commercial‑relevant equipment and consumables.
Experience supporting tech transfer and implementation at internal sites and CDMOs.
Exposure to PAT/digital tools for process monitoring and data integrity; experience with knowledge management systems.
Demonstrated innovation in evaluating/implementing next‑generation purification technologies.
Compensation Pay Range:
$97,372.00 – $146,058.00 USD Annual. Base pay may vary based on market location, job‑related knowledge, skills, and experience. In addition, short‑term incentive bonus opportunities and eligibility for equity‑based long‑term incentive programs may be offered. Benefits include a qualified retirement plan, paid vacation and holidays, paid leaves, and health benefits (medical, prescription drug, dental, and vision) in accordance with applicable plans. If hired, you will be in an “at‑will” position; the Company reserves the right to modify base pay or other compensation at any time.
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 continually 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 difference—apply today!
Closing Date:
29-Jan-2026
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.
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Key Responsibilities
Downstream Process Development:
Plan and perform experiments to develop scalable, cost‑effective LVV purification processes for ex vivo and in vivo applications, targeting yield, purity, potency, and consistency.
Unit Operations Execution:
Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation/fill‑related steps; define phase‑appropriate in‑process controls and operating ranges.
Process Characterization & Data Analysis:
Design and analyze studies (including DOE) to identify CPPs/CMAs, establish design space, and justify control strategies; trend performance, conduct troubleshooting and root‑cause analysis, and recommend corrective actions.
Scale‑Up, Scale‑Down & Tech Transfer Support:
Develop representative scale‑down models; support scale‑up to pilot, clinical, and commercial‑relevant equipment; prepare technical transfer documents and assist transfers to internal GMP sites and CDMOs.
Novel Technologies & Continuous Improvement:
Evaluate and implement next‑generation purification technologies and consumables to improve efficiency, robustness, and product quality; contribute to continuous improvement initiatives.
Documentation & Compliance:
Author high‑quality protocols, reports, batch records, and development summaries; support drafting of CMC content for regulatory submissions (e.g., IND) and align practices with cGMP and Quality systems expectations.
Cross‑Functional Collaboration:
Partner with upstream PD and Analytical Development to link process parameters with product quality attributes (e.g., titer, infectivity/potency, residuals/impurities); collaborate with Manufacturing and Quality on operational feasibility and compliance.
Qualifications
Education:
PhD in Biochemical/Chemical Engineering, Biotechnology, or related field with 2–5 years of relevant industry experience; or MS with 5–8 years; or BS with 8–10 years. Cell and gene therapy experience preferred. Title will be commensurate with qualifications and experience.
Experience:
Hands‑on downstream process development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale considerations and tech transfer.
Technical Expertise:
Practical proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation; understanding of viral vector‑specific impurity profiles (host cell proteins/DNA, process residuals) and strategies to control them.
Data & Risk Tools:
Working knowledge of statistical analysis and DOE; familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification.
GMP & Regulatory:
Understanding of cGMP and Quality systems; familiarity with FDA/EMA guidance relevant to gene and cell therapy; experience contributing to CMC sections of regulatory filings is a plus.
Communication & Collaboration:
Strong written and verbal communication; ability to work effectively in cross‑functional, matrixed teams; demonstrated problem‑solving and troubleshooting skills.
Preferred Qualifications
Experience scaling LVV or other viral vector/biologic purification processes from preclinical to clinical/commercial‑relevant equipment and consumables.
Experience supporting tech transfer and implementation at internal sites and CDMOs.
Exposure to PAT/digital tools for process monitoring and data integrity; experience with knowledge management systems.
Demonstrated innovation in evaluating/implementing next‑generation purification technologies.
Compensation Pay Range:
$97,372.00 – $146,058.00 USD Annual. Base pay may vary based on market location, job‑related knowledge, skills, and experience. In addition, short‑term incentive bonus opportunities and eligibility for equity‑based long‑term incentive programs may be offered. Benefits include a qualified retirement plan, paid vacation and holidays, paid leaves, and health benefits (medical, prescription drug, dental, and vision) in accordance with applicable plans. If hired, you will be in an “at‑will” position; the Company reserves the right to modify base pay or other compensation at any time.
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 continually 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 difference—apply today!
Closing Date:
29-Jan-2026
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.
#J-18808-Ljbffr