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Director Process Development Jobs in Frederick, MD

BioNTech SE

Director, Analytical Development

Gaithersburg, MD · On-site

$168.10K - $268.70K/yr

As Director of Analytical Development, you will play a pivotal role in advancing BioNTech's mission ... Partnering with cross-functional teams in Process Development, Global Technical Development, AS&T ...

AstraZeneca

Process Engineer

Rockville, MD

This position will report to Director, MS&T, Cell Therapy Development and Operations. Key Responsibilities Site manufacturing support Process Execution Support: Provide day-to-day technical support ...

AstraZeneca

Process Engineer

Rockville, MD

... development and/or manufacturing, as well asexpertisein technology transfer. Experience with process validation and commercialization activities is desired. This position will report to Director, MS ...

AstraZeneca

Process Engineer

Rockville, MD · On-site

This position will report to Director, MS&T, Cell Therapy Development and Operations. Key Responsibilities Site manufacturing support • Process Execution Support: Provide day-to-day technical ...

AstraZeneca

Process Engineer

Rockville, MD · On-site

This position will report to Director, MS&T, Cell Therapy Development and Operations. Key Responsibilities Site manufacturing support • Process Execution Support: Provide day-to-day technical ...

Astrazeneca

Director Product Quality Leader

Rockville, MD

$167.60K - $251.39K/yr

Partner closely with Process Development,Analytical Sciences, Supply Chain,Quality, Regulatory ... direct authority The annual base pay for this position ranges from $167,595.20 - 251,392.80. Our ...

AstraZeneca

Director Product Quality Leader

Rockville, MD

$167.60K - $251.39K/yr

Partner closely with Process Development,Analytical Sciences, Supply Chain,Quality, Regulatory ... direct authority The annual base pay for this position ranges from $167,595.20 - 251,392.80. Our ...

AstraZeneca

Director Product Quality Leader

Rockville, MD · On-site

$167.60K - $251.39K/yr

Partner closely with Process Development, Analytical Sciences, Supply Chain, Quality, Regulatory ... direct authority The annual base pay for this position ranges from $167,595.20 - 251,392.80. Our ...

AstraZeneca

Director Product Quality Leader

Rockville, MD

$167.60K - $251.39K/yr

... Process Development, Analytical Sciences, Supply Chain, Quality, Regulatory Affairs, Program ... direct authority The annual base pay for this position ranges from $167,595.20 - 251,392.80. Our ...

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Director Process Development information

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$42.8K

$82.1K

$161.1K

How much do director process development jobs pay per year?

As of May 31, 2026, the average yearly pay for director process development in Frederick, MD is $82,125.00, according to ZipRecruiter salary data. Most workers in this role earn between $54,700.00 and $96,900.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Director of Process Development, and why are they important?

To thrive as a Director of Process Development, you need deep expertise in process engineering, project management, and a strong background in chemistry, biochemistry, or a related field, often supported by an advanced degree. Familiarity with process modeling software, statistical analysis tools, and industry-specific quality standards such as GMP or Six Sigma certifications is typically required. Exceptional leadership, strategic thinking, and cross-functional communication skills set top performers apart in this role. These abilities are essential for driving efficient process innovation, ensuring regulatory compliance, and leading teams toward operational excellence.

How does a Director of Process Development typically collaborate with cross-functional teams to drive project success?

As a Director of Process Development, you will regularly work alongside R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams to ensure new processes are scalable, compliant, and align with business goals. This collaboration often involves leading cross-departmental meetings, aligning on project milestones, and troubleshooting process bottlenecks together. Strong communication and leadership skills are crucial, as you’ll be responsible for integrating feedback, managing diverse perspectives, and ensuring that project deliverables are met on time and within budget.

What does a Director of Process Development do?

A Director of Process Development is responsible for overseeing the design, implementation, and optimization of processes within an organization, typically in manufacturing, biotech, or pharmaceutical industries. They lead teams to develop efficient, cost-effective, and scalable processes for producing products or delivering services. This role often involves coordinating cross-functional teams, ensuring regulatory compliance, and driving continuous improvement initiatives. The Director also collaborates with R&D, quality, and production departments to bring new products from concept to commercial scale.

What job pays 400,000 a year without a degree?

A Director of Process Development typically requires advanced technical skills and experience, and such high salaries are usually associated with executive roles that often require a degree. However, some specialized roles in sales, entrepreneurship, or certain trades can reach or exceed this level without formal higher education, especially with proven expertise and industry success.

What is the difference between Director Process Development vs Process Engineer?

AspectDirector Process DevelopmentProcess Engineer
CredentialsBachelor's/Master's in Engineering or related field, often with leadership experienceBachelor's or Master's in Engineering or related field
Work EnvironmentStrategic planning, team leadership, cross-department collaborationHands-on process design, optimization, and troubleshooting
Industry UsageCommonly used in biotech, pharma, and manufacturing industriesUsed across similar industries for process development and improvement

The main difference is that the Director Process Development oversees strategic process initiatives and manages teams, while the Process Engineer focuses on executing process improvements and technical tasks. The director role involves higher-level planning and leadership, whereas the engineer role is more hands-on and technical.

What are popular job titles related to Director Process Development jobs in Frederick, MD? For Director Process Development jobs in Frederick, MD, the most frequently searched job titles are:
What job categories do people searching Director Process Development jobs in Frederick, MD look for? The top searched job categories for Director Process Development jobs in Frederick, MD are:
What cities near Frederick, MD are hiring for Director Process Development jobs? Cities near Frederick, MD with the most Director Process Development job openings:
Director Process Development jobs near you
Executive Director, Process Engineering

Executive Director, Process Engineering

AstraZeneca

Gaithersburg, MD • On-site

Full-time

Posted 3 days ago

AstraZeneca rating

8.6

Company rating: 8.6 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

16th of 70 rated pharmaceutical

Job description

If you have the passion and the drive to accelerate growth and make people's lives better - then AstraZeneca is the place for you. In Operations we have a big ambition - to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.
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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