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Biotech Process Development Jobs in Rockville, MD

Guidehouse

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 ...

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Biotech Process Development information

See Rockville, MD salary details

$19

$34

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How much do biotech process development jobs pay per hour?

As of Aug 15, 2026, the average hourly pay for biotech process development in Rockville, MD is $34.33, according to ZipRecruiter salary data. Most workers in this role earn between $28.17 and $42.16 per hour, depending on experience, location, and employer.

What is biotech process development?

Biotech process development refers to the design, optimization, and scale-up of manufacturing processes used to produce biological products, such as pharmaceuticals, enzymes, or vaccines. Professionals in this field work to turn laboratory procedures into efficient, large-scale industrial processes that meet regulatory and quality standards. This often involves selecting suitable equipment, optimizing conditions, ensuring reproducibility, and troubleshooting production issues. The ultimate goal is to produce high-quality products safely, consistently, and cost-effectively.

What is the difference between Biotech Process Development vs Biotech Manufacturing Associate?

AspectBiotech Process DevelopmentBiotech Manufacturing Associate
Primary FocusDesigning, optimizing, and scaling up bioprocesses for product developmentExecuting manufacturing processes to produce biopharmaceuticals at scale
Work EnvironmentLaboratories and pilot plant facilitiesProduction floors and manufacturing plants
Required SkillsProcess design, lab techniques, troubleshootingEquipment operation, quality control, adherence to SOPs
Typical CredentialsBSc/MSc in Biotechnology, Chemical Engineering, or related fieldsBSc 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?

To excel in Biotech Process Development, you need a strong background in bioprocess engineering, molecular biology, and chemistry, typically supported by a degree in biotechnology or related fields. Familiarity with tools such as bioreactors, chromatography systems, and data analysis software, along with certifications in Good Manufacturing Practice (GMP), is highly valuable. Strong problem-solving skills, attention to detail, and effective teamwork distinguish top performers in this role. These competencies are crucial for optimizing processes, ensuring product quality, and driving innovation in the biotech industry.

What are some common challenges faced by professionals in biotech process development, and how are they typically addressed?

Professionals in Biotech Process Development often encounter challenges related to scaling up processes from the laboratory to commercial production, ensuring product consistency, and meeting strict regulatory standards. Addressing these challenges typically involves close collaboration with cross-functional teams such as quality assurance, regulatory affairs, and manufacturing. Continuous process optimization, thorough documentation, and robust validation protocols are essential strategies to overcome these hurdles and ensure successful product development and commercialization.

What are popular job titles related to Biotech Process Development jobs in Rockville, MD?

For Biotech Process Development jobs in Rockville, MD, the most frequently searched job titles are:

What job categories do people searching Biotech Process Development jobs in Rockville, MD look for?

The top searched job categories for Biotech Process Development jobs in Rockville, MD are:

What cities near Rockville, MD are hiring for Biotech Process Development jobs?

Cities near Rockville, MD with the most Biotech Process Development job openings:

Biotech Process Development jobs near you

Executive Director, Process Engineering

AstraZeneca

Gaithersburg, MD • On-site

Full-time

Re-posted 19 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

22nd of 86 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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