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AstraZeneca · 13 hours ago

Principal Engineer CDC

Durham, NC

Full-time

Hybrid

Senior Level, Lead/Staff

$176K/yr - $263K/yr

5+ years exp

AstraZeneca is a leading pharmaceutical company focused on delivering innovative medicines. As Principal Engineer Continuous Direct Compression (CDC), you will coordinate and lead CDC process and equipment design, development, and optimisation for oral solid dose drug product development projects.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Lead our engineering capability in CDC, to design and develop robust manufacturing processes for new pharmaceutical formulations, ensuring compliance with industry standards

Drive effective technical risk management to ensure that appropriate activities are conducted throughout development to deliver robust commercial manufacture

Work effectively with colleagues across Global Product Development, Global Operations and at our external manufacturing partners, to define critical process parameters (CPPs) that influence product quality, in consideration of the wider product control strategy

Expedite adoption and advancement of in silico process modelling and control in CDC, and progress our capabilities in advanced process control

Lead technology transfer and process validation approaches in CDC

Liaise effectively across the AstraZeneca technical and supply network to influence network capability requirements for CDC

Work with equipment manufacturers to evaluate and specify technology improvements, in line with AstraZeneca product and portfolio requirements

Provide leadership and coaching to other scientists and engineers within the group, supporting their development to build capability essential to the delivery of the present and future project portfolio

Demonstrate creativity and innovation, driving and supporting a culture of scientific excellence in projects

Stay updated on industry trends, emerging technologies, and best practices in continuous processing to foster innovation within the organization

Qualification

Chemical EngineeringContinuous Direct CompressionOral Solid Dose DevelopmentPredictive Science ToolsProcess ValidationStakeholder ManagementCollaboration SkillsOrganizational SkillsCommunication Skills

Required

BSc/PhD level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry is essential

Minimum 5 years relevant experience

Industrial experience in pharmaceutical spray drying with a degree in chemical engineering or a closely related scientific discipline

Industrial experience in CDC with a degree in chemical engineering or a closely related scientific discipline

Experience and thorough understanding of oral solid dose drug product development and commercialisation process

Proven track record of delivering multiple and/or complex late-stage oral drug product development projects, including technology transfer, scale up and validation of CDC processes

Experience of using predictive science / digital tools

Experience in development of drug product control strategies, bringing together different aspects of pharmaceutical sciences

Strong collaborative working and communication skills, including ability to work effectively with colleagues from diverse backgrounds and different skill areas

Good organisational and planning skills with the ability to deliver to agreed time and quality

Excellent stakeholder management skills

Preferred

Experience in development, scale up and technology transfer of a range of other drug product manufacturing processes, eg granulation, tablet compression, coating

Experience in clinical and commercial regulatory authoring and defence

Experience of working with external suppliers (such as CMO/CRO for outsourced development and supply) and managing productive relationships

Experience with automation platforms and process modelling

Benefits

Short-term incentive bonus opportunity

Equity-based long-term incentive program (salaried roles)

Retirement contribution (hourly roles)

Commission payment eligibility (sales roles)

Qualified retirement program [401(k) plan]

Paid vacation and holidays

Paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)