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Biotech Process Development Jobs in Gaithersburg, MD

Kite Pharma

Cell Therapy Specialist I

Frederick, MD

$60K - $77K/yr

Work as part of a small team to execute GMP runs in close collaboration with Process Development ... Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic ...

Kite Pharma

Cell Therapy Specialist I

Frederick, MD

$60K - $77K/yr

Work as part of a small team to execute GMP runs in close collaboration with Process Development ... Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic ...

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All JobsBiotech Process Development JobsBiotech Process Development Jobs in Gaithersburg, MD

Biotech Process Development information

See Gaithersburg, MD salary details

$20

$36

$53

How much do biotech process development jobs pay per hour?

As of Aug 9, 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:
Biotech Process Development jobs near you

MSAT Bioprocess Engineer III / IV

Theradaptive

Frederick, MD • On-site

Full-time

Posted 9 days ago

Job description

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of biology and tissue repair.
Our lead therapeutics are in the following indications:
  • Spinal Fusion
  • Long Bone Repair
  • Osteochondral Repair
  • Dental and Facial Bone Repair
  • Immuno-Oncology

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.
POSITION SUMMARY
Theradaptive is seeking a skilled and driven MSAT Process Engineer III/IV to join our Manufacturing Science and Technology team. This role will provide hands-on technical leadership and manufacturing support for GMP operations, lead deviation investigations and CAPA activities, support process validation and continued process verification (CPV), and partner cross-functionally to advance Theradaptive's combination product pipeline. The successful candidate will bring strong technical judgment, a data-driven approach to problem solving, and the ability to translate process knowledge into robust, compliant, and scalable manufacturing solutions.
Travel requirement: Up to 10%, primarily to support CMO/CDMO technology transfer activities.
RESPONSIBILITIES
GMP Manufacturing Support
  • Serve as the primary technical point of contact for day-to-day GMP manufacturing operations.
  • Monitor real-time manufacturing activities, troubleshoot process issues, and drive timely resolution of technical challenges.
  • Ensure manufacturing processes remain continuously aligned with cGMP requirements and applicable regulatory expectations.

Deviation Management & Investigations
  • Lead and independently author deviation investigations, applying structured root cause analysis (RCA) methodologies (e.g., 5-Why, Fishbone, FTA).
  • Develop and track robust CAPA plans; assess effectiveness and drive closure in a compliant and timely manner.
  • Manage change control activities, evaluating technical impact and ensuring thorough documentation.

Process Validation & Continued Process Verification (CPV)
  • Own and execute process validation activities including Process Performance Qualification (PPQ) protocols and reports.
  • Apply Design of Experiments (DOE) principles to support process characterization, parameter optimization, validation strategy, and establishment of robust process control ranges.
  • Analyze CPV metrics and process datasets to proactively identify trends, risks, and opportunities for improvement.
  • Support product lifecycle management and post-approval change activities.

Technology Transfer
  • Lead or support technology transfer activities between process development, internal GMP manufacturing, and external contract manufacturing organizations (CMOs/CDMOs).
  • Author and review technology transfer plans, batch records, and technical reports to ensure manufacturing readiness.
  • Drive process scale-up and process improvement activities by translating development-scale processes into robust, scalable, and GMP-ready manufacturing operations.

GMP Documentation
  • Author, review, and approve GMP documentation including deviations, technical reports, validation protocols/reports, change controls, and SOPs.
  • Maintain high documentation standards consistent with regulatory expectations and internal quality systems.

Cross-Functional Collaboration & Continuous Improvement
  • Partner cross-functionally with Manufacturing, QC, QA, Supply Chain, and Regulatory teams to drive compliant, efficient operations.
  • Champion continuous improvement initiatives and apply process excellence principles to manufacturing performance.
  • Participate in audit and inspection readiness activities, including preparation of technical summaries and subject-matter expert support.

QUALIFICATIONS
  • Bachelor's or master's degree in engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
  • Minimum 4-8 years of progressive experience in MSAT, Bio process engineering, or process development, GMP manufacturing support in biologics or medical devices,
  • Demonstrated ability to independently lead deviation investigations, CAPA development, and change control activities.
  • Hands-on experience with process validation (PV), Process Performance Qualification (PPQ) and CPV programs.
  • Prior involvement in technology transfer activities, including transfers to or from CMO/CDMO partners, preferred.
  • Working knowledge of biologics unit operations, including one or more of the following:
    • Cell culture (mammalian, microbial, or primary cell systems)
    • Downstream purification (chromatography, filtration, centrifugation)
    • Formulation and fill-finish operations
  • Experience with statistical data analysis, SPC charting, and process trending tools.
  • Familiarity with regulatory frameworks including FDA 21 CFR Part 211/600, ICH Q8/Q9/Q10, and ISO standards.
  • Proficiency with GMP documentation systems (electronic or paper-based) and quality management systems (e.g., Track Wise, Master Control).
  • Data-driven problem solver with strong scientific judgment.
  • Clear technical communicator and cross-functional collaborator.
  • Detail-oriented, accountable, adaptable, and improvement-minded.

PHYSICAL DEMANDS
  • Ability to work in classified cleanroom environments and meet all applicable gowning and PPE requirements.
  • Capacity to stand for extended periods and perform repetitive technical tasks in a GMP setting.
  • Ability to lift and handle laboratory equipment and supplies as required.

COMPENSATION RANGE:
$108,000-$139,000 annually, based on qualifications and level.
POSITION LOCATION:
On-site at Theradaptive's corporate headquarters in Frederick, MD.
https://www.theradaptive.com
Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or

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