AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life ... Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master ...
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life ... Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master ...
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life ... Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master ...
AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life ... Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master ...
... Development and Process Development through Technology Transfer, Clinical Manufacturing, and ... You will work with innovative biotech companies and leading pharmaceutical organizations to advance ...
... Development and Process Development through Technology Transfer, Clinical Manufacturing, and ... You will work with innovative biotech companies and leading pharmaceutical organizations to advance ...
... Development and Process Development through Technology Transfer, Clinical Manufacturing, and ... You will work with innovative biotech companies and leading pharmaceutical organizations to advance ...
... Development and Process Development through Technology Transfer, Clinical Manufacturing, and ... You will work with innovative biotech companies and leading pharmaceutical organizations to advance ...
Process Engineer MS&T -Drug Product
Germantown, MD · On-site
$90K - $110K/yr
Precigen has developed novel manufacturing processes to deliver UltraCAR-T ® and AdenoVerse™ ... Sc in Chemical Engineering, Bioengineering, Biotechnology or another relevant engineering ...
Quick apply
Process Engineer MS&T -Drug Product
Germantown, MD · On-site
$90K - $110K/yr
Precigen has developed novel manufacturing processes to deliver UltraCAR-T ® and AdenoVerse™ ... Sc in Chemical Engineering, Bioengineering, Biotechnology or another relevant engineering ...
Biotech Associate
Baltimore, MD · Hybrid
Expected to provide investment insights and impact the investment process for both public and ... Basic understanding of fundamental drug development research and preclinical / clinical data ...
Biotech Associate
Baltimore, MD · Hybrid
Expected to provide investment insights and impact the investment process for both public and ... Basic understanding of fundamental drug development research and preclinical / clinical data ...
S. commercial presence in San Francisco, CA to strengthen engagement in key biotech hubs. This growth is driven by capabilities across CLD, process development (upstream/downstream), tech transfer ...
S. commercial presence in San Francisco, CA to strengthen engagement in key biotech hubs. This growth is driven by capabilities across CLD, process development (upstream/downstream), tech transfer ...
S. commercial presence in San Francisco, CA to strengthen engagement in key biotech hubs. This growth is driven by capabilities across CLD, process development (upstream/downstream), tech transfer ...
S. commercial presence in San Francisco, CA to strengthen engagement in key biotech hubs. This growth is driven by capabilities across CLD, process development (upstream/downstream), tech transfer ...
S. commercial presence in Boston, MA to strengthen engagement in key biotech hubs. This growth is driven by capabilities across CLD, process development (upstream/downstream), tech transfer, and GMP ...
S. commercial presence in Boston, MA to strengthen engagement in key biotech hubs. This growth is driven by capabilities across CLD, process development (upstream/downstream), tech transfer, and GMP ...
S. commercial presence in Boston, MA to strengthen engagement in key biotech hubs. This growth is driven by capabilities across CLD, process development (upstream/downstream), tech transfer, and GMP ...
S. commercial presence in Boston, MA to strengthen engagement in key biotech hubs. This growth is driven by capabilities across CLD, process development (upstream/downstream), tech transfer, and GMP ...
This organization is a strategic partner to leading pharmaceutical and biotech companies ... Lead process development activities including formulation, process optimization, scale-up ...
Quick apply
This organization is a strategic partner to leading pharmaceutical and biotech companies ... Lead process development activities including formulation, process optimization, scale-up ...
Bioassay Researcher
Silver Spring, MD · On-site
$85K - $141K/yr
Understanding of biopharmaceutical manufacturing, process development, biotechnology research and regulatory operations. * Knowledge of insulin and GLP-1 receptor signaling pathways or related ...
Bioassay Researcher
Silver Spring, MD · On-site
$85K - $141K/yr
Understanding of biopharmaceutical manufacturing, process development, biotechnology research and regulatory operations. * Knowledge of insulin and GLP-1 receptor signaling pathways or related ...
Bioassay Researcher
$85K - $141K/yr
Understanding of biopharmaceutical manufacturing, process development, biotechnology research and regulatory operations. * Knowledge of insulin and GLP-1 receptor signaling pathways or related ...
Bioassay Researcher
$85K - $141K/yr
Understanding of biopharmaceutical manufacturing, process development, biotechnology research and regulatory operations. * Knowledge of insulin and GLP-1 receptor signaling pathways or related ...
CRA 1, IQVIA Biotech
Rockville, MD · On-site
$71K - $145K/yr
... level financial processes or startup activities based on study needs. Accurate and timely ... We create intelligent connections to accelerate the development and commercialization of innovative ...
CRA 1, IQVIA Biotech
Rockville, MD · On-site
$71K - $145K/yr
... level financial processes or startup activities based on study needs. Accurate and timely ... We create intelligent connections to accelerate the development and commercialization of innovative ...
Scientist - NIH VRC
$53.33/hr
Purification development experience for GMP process development in biotech/pharmaceutical or related industry (experience in clinical manufacturing is highly desirable). Must be a team player who can ...
Scientist - NIH VRC
$53.33/hr
Purification development experience for GMP process development in biotech/pharmaceutical or related industry (experience in clinical manufacturing is highly desirable). Must be a team player who can ...
Biotech Associate
Baltimore, MD · Hybrid
Expected to provide investment insights and impact the investment process for both public and ... Basic understanding of fundamental drug development research and preclinical / clinical data ...
Biotech Associate
Baltimore, MD · Hybrid
Expected to provide investment insights and impact the investment process for both public and ... Basic understanding of fundamental drug development research and preclinical / clinical data ...
Manufacturing Technician I
Rockville, MD · On-site
Contribute to process improvement initiatives and support assay and process development activities ... Associate or bachelor's degree in Biology, Chemistry, Biotechnology, Engineering, or a related ...
New
Quick apply
Manufacturing Technician I
Rockville, MD · On-site
Contribute to process improvement initiatives and support assay and process development activities ... Associate or bachelor's degree in Biology, Chemistry, Biotechnology, Engineering, or a related ...
New
CRA 1, IQVIA Biotech
$71K - $145K/yr
... level financial processes or startup activities based on study needs. Accurate and timely ... We create intelligent connections to accelerate the development and commercialization of innovative ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
... level financial processes or startup activities based on study needs. Accurate and timely ... We create intelligent connections to accelerate the development and commercialization of innovative ...
Senior Pharmaceutical Business Development and Portfolio Management SME | Healthcare and Life Sci...
Washington, DC · On-site
ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT ... biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of ...
Senior Pharmaceutical Business Development and Portfolio Management SME | Healthcare and Life Sci...
Washington, DC · On-site
ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT ... biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of ...
... procurement process begins, and position Emmes as a strategic partner early in sponsors ... Strong network across biotech and pharma with the ability to convert relationships into early ...
... procurement process begins, and position Emmes as a strategic partner early in sponsors ... Strong network across biotech and pharma with the ability to convert relationships into early ...
Biotech Process Development information
See Silver Spring, MD salary details
$19.63 - $22.50
3% of jobs
$22.50 - $25.37
6% of jobs
$25.37 - $28.24
12% of jobs
$28.73 is the 25th percentile. Wages below this are outliers.
$28.24 - $31.11
23% of jobs
The median wage is $32.24 / hr.
$31.11 - $33.98
15% of jobs
$33.98 - $36.85
15% of jobs
$38.04 is the 75th percentile. Wages above this are outliers.
$36.85 - $39.72
3% of jobs
$39.72 - $42.58
3% of jobs
$42.58 - $45.45
6% of jobs
$45.45 - $48.32
3% of jobs
$48.32 - $51.19
11% of jobs
$19
$34
$51
How much do biotech process development jobs pay per hour?
What is biotech process development?
What is the difference between Biotech Process Development vs Biotech Manufacturing Associate?
| Aspect | Biotech Process Development | Biotech Manufacturing Associate |
|---|---|---|
| Primary Focus | Designing, optimizing, and scaling up bioprocesses for product development | Executing manufacturing processes to produce biopharmaceuticals at scale |
| Work Environment | Laboratories and pilot plant facilities | Production floors and manufacturing plants |
| Required Skills | Process design, lab techniques, troubleshooting | Equipment operation, quality control, adherence to SOPs |
| Typical Credentials | BSc/MSc in Biotechnology, Chemical Engineering, or related fields | BSc in Biotechnology, Biology, or related fields |
While both roles are essential in biotech, Biotech Process Development focuses on creating and optimizing processes during product development, whereas Biotech Manufacturing Associates handle the day-to-day production to ensure consistent product quality at scale.
What are the key skills and qualifications needed to thrive in biotech process development, and why are they important?
What are some common challenges faced by professionals in biotech process development, and how are they typically addressed?

Full-time
Re-posted 9 days ago
AstraZeneca rating
8.4
Based on 45 frontline employees who took The Breakroom Quiz
20th of 86 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.
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