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Biotech Process Development Jobs in Gaithersburg, MD

CRA 1, IQVIA Biotech

Rockville, MD · On-site

$71K - $119K/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 ...

... 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 - $119K/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 ...

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 ...

... 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 ...

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Biotech Process Development information

See Gaithersburg, MD salary details

$20

$36

$53

How much do biotech process development jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for biotech process development in Gaithersburg, MD is $36.39, according to ZipRecruiter salary data. Most workers in this role earn between $29.86 and $44.66 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 Gaithersburg, MD? For Biotech Process Development jobs in Gaithersburg, MD, the most frequently searched job titles are:
What job categories do people searching Biotech Process Development jobs in Gaithersburg, MD look for? The top searched job categories for Biotech Process Development jobs in Gaithersburg, MD are:
What cities near Gaithersburg, MD are hiring for Biotech Process Development jobs? Cities near Gaithersburg, MD with the most Biotech Process Development job openings:
Scientist (Analytical Development, Cell Therapy)

Scientist (Analytical Development, Cell Therapy)

Astrazeneca

Gaithersburg, MD

$90K - $136K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 7 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 71 rated pharmaceutical


Job description

Scientist (Analytical Development, Cell Therapy)

Summary of the group

Join our Cell Therapy Analytical Development team, where we develop and deliver robust, technologically advanced biological assays to progress cell therapy products from research to commercial stages. Our team supports the end-to-end biological and bioanalyticalcharacterization ofviral vectorandcell therapy products, enablingmanufacturing processes, formulation, drug product development, and regulatory filings from IND to BLA and beyond. We collaborate closely with analytical quality and several cross-functional teams, including clinical, regulatory, QA, and manufacturing.

Accountabilities

  • Develop robustfunctional, characterization, and molecular analytical methods including method qualification and transfer.

  • Make detailed observations, analyze data, interpret results, and exerciseappropriate technicaldiscretion in the design, execution, and interpretation of experiments independently.

  • Carry outanalytical development/sample testing to enablelentiviral vectorupstream and downstream processdevelopment.

  • Author/reviewtechnical reports, protocols, and technical summaries for presentation.

  • Present and discuss experimental results at group/project team meetings.

  • Workin a team-based structure and interface with research and process development departments.

Essential Skills/Experience

  • Bachelor's degree in Immunology, Cell Biology, Biological Sciences, Biotechnology, or related field with5+years of relevant experience or aMaster'sdegree in Immunology, Cell Biology, Biological Sciences, Biotechnology, or related field with3+ years of relevant experience.

  • Biotechnology or pharmaceutical industry experience working withanalyticalforlentiviral vectorand CAR T cellsisrequired.

  • Experiencemethod qualification/validationandtech transfer ofcell and gene therapy analytical methods isarequired.

  • Highly proficientinimmunology techniques isrequired, such asELISA or similar technology platforms.

  • Highly proficientinmolecular biologytechniques isrequired, such asqPCR,dPCR,for gene edit evaluation,on target/off target analysis.

  • Exhibit excellent written and oral communication skills.

  • Good timemanagement and organizational skills with the ability to prioritize tasks from multiple projects to meet timelines.

Desirable Skills/Experience

  • Experience inbiophysicalanalysissuch as DLS, HPLC,massspectrometry and capillary electrophoresis, Flowvirometryis a plusfor lentiviral vectorcharacterization isa plus.

  • Experience withNGS is a plus

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work atpaceand challenge perceptions.That'swhy we work, on average, a minimum of three days per week from the office. But thatdoesn'tmeanwe'renot flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by our commitment to deliver accelerated growth and make people's lives better. Our inclusive network of diverse and high-performing teams supports each other with trust and respect. We thrive on curiosity and problem-solving, constantly learning and evolving. With opportunities for global careers and great rewards, AstraZeneca is where you can make a real impact.Ready to make a difference? Apply now to join our team!

The annual base pay for this position ranges from $90,961 to $136,441. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

04-Jun-2026

Closing Date

11-Jun-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.


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