Top 11 Msat Jobs in Frederick, Md

MSAT Bioprocess Engineer III / IV
Theradaptive —Frederick, MD
- $108,000 - $139,000 a year
- Engineering
- Travel
- In-person
Director, MSAT
Lonza —Walkersville, MD
- $205,200 - $239,400 a year
- Full-time
- Engineering
- 11+ years
- Presentation skills
- Disability insurance
- Health insurance
Associate Director, MSAT
Lonza —Walkersville, MD
- $174,600 - $203,700 a year
- Full-time
- Engineering
- Bachelor's degree
- Travel
- Disability insurance
- Health insurance
Director, Manufacturing
Lonza —Walkersville, MD
- $198,900 - $232,050 a year
- Full-time
- Engineering
- 11+ years
- Presentation skills
- Disability insurance
- Health insurance
Director, Operations
Lonza —Walkersville, MD
- $198,900 - $232,050 a year
- Full-time
- Engineering
- 11+ years
- Travel
- Disability insurance
- Health insurance
Director, Automation
Lonza —Walkersville, MD
- $203,400 - $237,300 a year
- Full-time
- Computer Science
- System design
- 11+ years
- Disability insurance
- Health insurance
4d
Associate Director, MS&T Raw Material Specialist
BioNTech AG —Gaithersburg, MD
- $146,300 - $234,100 a year
- Full-time
- Background check
- 6 years
- Doctor of Philosophy
- Health savings account
- AD&D insurance
13d
Director, Process & Analytical Development
Lonza —Walkersville, MD
- $196,700 - $232,650 a year
- Full-time
- Engineering
- 11+ years
- Doctor of Philosophy
- Disability insurance
- Health insurance
1d
Associate Director, Maintenance
Lonza —Walkersville, MD
- $174,000 - $203,000 a year
- Full-time
- Engineering
- Travel
- In-person
- Disability insurance
- Health insurance
2d
Associate Director, Process & Analytical Development
Lonza —Walkersville, MD
- $155,700 - $181,650 a year
- Full-time
- Engineering
- In-person
- Senior level
- Disability insurance
- Health insurance
1d
Assistant or Associate Professor of Physical Therapy
Shenandoah University —Leesburg, VA
- Full-time
- Background check
- Laboratory
- Classroom
Quick Apply

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MSAT Bioprocess Engineer III / IV

Theradaptive -
Frederick, MD

Apply Now

Job Details

$108,000 - $139,000 a year

Qualifications

Technical engineering
Document control experience within pharmaceutical industry
Quality control statistical data analysis
Statistical Process Control
Production deviation management
Corrective and preventive actions (CAPA)
GMP
Cleanroom protocols
Internal investigations
Personal protective equipment (PPE) adherence
Statistical analysis
Production validation processes
Cleanroom gowning procedures
ICH Q10
Bioprocessing
Biomedical regulatory compliance
Cross-functional communication
Pharmaceutical manufacturing facility experience

Full 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

Apply Now

Refine Your Search

msat jobs in frederick, md

MSAT Bioprocess Engineer III / IV

Director, MSAT

Associate Director, MSAT

Director, Manufacturing

Director, Operations

Director, Automation

Associate Director, MS&T Raw Material Specialist

Director, Process & Analytical Development

Associate Director, Maintenance

Associate Director, Process & Analytical Development

Assistant or Associate Professor of Physical Therapy

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