AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. Operations is ...
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. Operations is ...
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. Operations is ...
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. Operations is ...
PROCESS ENGINEER - Development Support - 10+ yrs of Experience - TS/SCI w/Poly clearance is required
Linthicum Heights, MD · Hybrid
$210 - $216/mo
Process Engineer - Development Support - 10+ yrs of Experience - TS/SCI w/Poly Required Halogen Engineering is looking for a Development Support Process Engineer on our team, you will support a ...
Quick apply
PROCESS ENGINEER - Development Support - 10+ yrs of Experience - TS/SCI w/Poly clearance is required
Linthicum Heights, MD · Hybrid
$210 - $216/mo
Process Engineer - Development Support - 10+ yrs of Experience - TS/SCI w/Poly Required Halogen Engineering is looking for a Development Support Process Engineer on our team, you will support a ...
Process Engineer - Drug Product
Germantown, MD · On-site
$90K - $110K/yr
Precigen has developed novel manufacturing processes to deliver UltraCAR-T ® and AdenoVerse™ immunotherapies to patients. The MS&T department is seeking a Process Engineer - Drug Product to ...
Quick apply
Process Engineer - Drug Product
Germantown, MD · On-site
$90K - $110K/yr
Precigen has developed novel manufacturing processes to deliver UltraCAR-T ® and AdenoVerse™ immunotherapies to patients. The MS&T department is seeking a Process Engineer - Drug Product to ...
Manufacturing/Process Engineer 2/3
$73K - $97K/yr
Supporting factory maintenance personnel with the troubleshooting and repair of process equipment Process Development: * Developing new, optimizing, maintaining and improving, manufacturing processes ...
Manufacturing/Process Engineer 2/3
$73K - $97K/yr
Supporting factory maintenance personnel with the troubleshooting and repair of process equipment Process Development: * Developing new, optimizing, maintaining and improving, manufacturing processes ...
Manufacturing/Process Engineer 2/3
Baltimore, MD · On-site
$73K - $97K/yr
Supporting factory maintenance personnel with the troubleshooting and repair of process equipment Process Development: * Developing new, optimizing, maintaining and improving, manufacturing processes ...
Manufacturing/Process Engineer 2/3
Baltimore, MD · On-site
$73K - $97K/yr
Supporting factory maintenance personnel with the troubleshooting and repair of process equipment Process Development: * Developing new, optimizing, maintaining and improving, manufacturing processes ...
This role supports process and product innovation to keep Catalent at the forefront of leading CDMOs. You will work on upstream fermentation development, clone selection, and technology improvements ...
New
This role supports process and product innovation to keep Catalent at the forefront of leading CDMOs. You will work on upstream fermentation development, clone selection, and technology improvements ...
New
Support early phase product and process development activities in collaboration with Drug Delivery Services. * Other duties as assigned. Supervisory Responsibilities: * N/A Knowledge & Other ...
Support early phase product and process development activities in collaboration with Drug Delivery Services. * Other duties as assigned. Supervisory Responsibilities: * N/A Knowledge & Other ...
Process Engineers
Annapolis Junction, MD · On-site
Work closely with the systems and software engineering process development team members to determine organizational readiness for assessment as well as in conducting assessments Coordinate and ...
Process Engineers
Annapolis Junction, MD · On-site
Work closely with the systems and software engineering process development team members to determine organizational readiness for assessment as well as in conducting assessments Coordinate and ...
Work closely with the systems and software engineering process development team members to determine organizational readiness for assessment as well as in conducting assessments Coordinate and ...
Work closely with the systems and software engineering process development team members to determine organizational readiness for assessment as well as in conducting assessments Coordinate and ...
Work closely with the systems and software engineering process development team members to determine organizational readiness for assessment as well as in conducting assessments Coordinate and ...
Work closely with the systems and software engineering process development team members to determine organizational readiness for assessment as well as in conducting assessments Coordinate and ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
Stevensville, MD · On-site
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Sr. / Principal Welding Process Engineer
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Quick apply
Sr. / Principal Welding Process Engineer
$116K - $156K/yr
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
This is a hands-on engineering capability development role centered on process development, qualification, and technical problem solving. You will work within a small, highly capable technical team ...
Process Development information
See Maryland salary details
$18.43 - $21.12
3% of jobs
$21.12 - $23.82
6% of jobs
$23.82 - $26.51
12% of jobs
$26.97 is the 25th percentile. Wages below this are outliers.
$26.51 - $29.21
23% of jobs
The median wage is $30.26 / hr.
$29.21 - $31.90
15% of jobs
$31.90 - $34.59
15% of jobs
$35.71 is the 75th percentile. Wages above this are outliers.
$34.59 - $37.29
3% of jobs
$37.29 - $39.98
3% of jobs
$39.98 - $42.67
6% of jobs
$42.67 - $45.37
3% of jobs
$45.37 - $48.06
11% of jobs
$18
$32
$48
How much do process development jobs pay per hour?
What jobs will no longer exist in 2030?
What jobs pay $10,000 a month without a degree?
What jobs in the US pay 300,000 a year?
What are the key skills and qualifications needed to thrive as a Process Development professional, and why are they important?
What does process development do?
What is the difference between Process Development vs Process Engineering?
| Aspect | Process Development | Process Engineering |
|---|---|---|
| Focus | Designing and optimizing new processes for products or manufacturing | Implementing, maintaining, and improving existing processes |
| Work Stage | Early-stage process creation and testing | Scaling up, troubleshooting, and sustaining processes |
| Skills & Certifications | Chemical/biochemical engineering, lab skills, process modeling | Process optimization, quality control, engineering principles |
Process Development primarily focuses on creating and refining new processes, while Process Engineering emphasizes implementing and maintaining those processes in production. Both roles require similar technical backgrounds but differ in their stage of involvement within the product lifecycle.
What is process development?
What are the main challenges faced by professionals in Process Development, and how are they typically addressed?
- Contract Engineering
- Executive Casting Simulation
- Research And Development Mechanical Engineer
- Biotech Process Development
- Eric V Stearley Cpc Associates
- Downstream Process Development Scientist
- Research Development Process Engineer
- Downstream Process
- Senior Engineer Metallurgy
- Fulltime Msat Process Engineer
Full-time
Posted 21 hours ago
AstraZeneca rating
8.6
Based on 43 frontline employees who took The Breakroom Quiz
16th of 73 rated pharmaceutical
Job description
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. Operations is accelerating, fast. We are on track for Our Bold Ambition 2030, delivering 15+ new medicines driving us forward across different modalities including biologics, cell therapy, ADCs and small molecules.
Position Summary
We are looking for an experienced Executive Director of Process Engineering to lead our cell therapy process engineering team. The Executive Director will oversee the design, scale-up, and optimization of cell therapy manufacturing processes. This is a new leadership position responsible for building out a team. You will help ensure that our cell therapy products are manufactured, cost-effectively, from early development through commercialization.
The Executive Director will collaborate with teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, to the successful development of process engineering solutions. We are looking for an understanding of cell therapy manufacturing, advanced process technologies, and regulatory requirements, and experience in leadership. You will report to the Vice president of Analytical and Process Development. The position can be based in Gaithersburg, MD or Santa Monica, CA.
Responsibilities
- Lead the Late-Stage Process Development function for Cell Therapies within the CTO, managing multiple development projects across several locations.
- Create and deploy global technical standards for cell therapy, focusing on process validation, sterility assurance, raw materials, single-use technology, and packaging, all within established quality systems.
- Design and oversee process validation, qualification, and monitoring strategies, implementing master validation plans for processes, equipment, and facilities in collaboration with Subject Matter Experts.
- Build and manage a multi-site organization that supports the product portfolio, ensuring efficient processes, knowledge exchange, and integration of lessons learned.
- Oversee resource allocation and make strategic "make vs. buy" decisions based on project priorities and technology strategies, adhering to CTO CGT governance processes.
- Drive innovation by integrating internal and external expertise, incorporating the latest technologies, and leading digital programs aligned with CTO CGT strategies.
- Ensure compliance with all relevant regulations (e.g., ISEC, GMP, HSE), and manage regulatory submissions, including the creation of source documents and dossier modules.
- Provide technical leadership for developing new and improved processes for high-quality cell therapy production.
- Author and review regulatory CMC packages for IND filings and approval applications (BLA/MAA/NDA).
- Address process development inquiries from health authorities during global product filings and approvals.
- Oversee and ensure the delivery of process development, qualification, and transfer from Process Development to Operations for GMP manufacturing of clinical and commercial cell therapy products.
- Fulfil all post-approval commitments for commercial products to health authorities.
Preferred Requirements
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master's degree with relevant industry experience.
- 10+ years of experience in process engineering preferred, with at least 10 years in a leadership role within the biotechnology or pharmaceutical industry with a focus on cell therapy or biologics.
- Experience in cell therapy or biologics manufacturing, including process design, scale-up, and optimization.
Skills and Competencies
- Knowledge in GxP compliance and data integrity.
- Proven track record in managing and leading a large, high-performing team (30+ members) with preferred expertise in CAR-T and human stem cell therapies, biologics, process development, transfer, validation, and automation.
- Demonstrated ability in developing value-added manufacturing processes from scratch.
- Diversified experience in a wide spectrum of CMC development suitable for adequately producing cell therapeutics.
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the Gaithersburg, MD or Santa Monica, CA office. 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 $269,000 to $328,900. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and 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.
Date Posted
05-Sep-2024
Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
What AstraZeneca employees say
Pay
Benefits
Hours and flexibility
Workplace
Get the full story on Breakroom