MSAT Bioprocess Engineer III / IV

Theradaptive•Frederick, MD

12d•Onsite

About The Position

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. 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.

Requirements

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.
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.

Nice To Haves

Prior involvement in technology transfer activities, including transfers to or from CMO/CDMO partners, preferred.

Responsibilities

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.
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.
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.
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.
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.
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.