Years of GMP Experience
Christopher Stasiak
Scientist
Effort,Pennsylvania
Summary
Detail-oriented biochemistry graduate with hands-on experience in GMP-compliant pharmaceutical manufacturing, biochemical assay development, and analytical instrumentation. Skilled in lab operations, protein purification, HPLC, and quantitative assay design. Integrating both industry and academic expertise to support pharmaceutical innovation and therapeutic development.
Overview
4
4
1
1
Certificate
Work History
Senior Process Technician
MTF Biologics
Jessup, United States
03.2024 - Current
- Formulated critical processing solutions (soaking, post‑processing, antibiotic, delipidization, sonication, demineralization) in compliance with GMP, GDP, and HCT/P regulations, ensuring product sterility, performance and biocompatibility.
- Collected and analyzed data on QuickGraft dimensions, contributing to the development of new medical devices and product lines, playing an integral role in the PST team’s efforts to create innovative device sizes to meet market demands.
- Collaborated with clinical stakeholders to assess medical device configurations; demonstrated graft-trimming techniques to meet target diameters and lengths for surgical application, and contributed to early evaluation of a new device design for product development.
- Prepared tissue and environmental samples following SOPs and AATB standards; uphold complete, audit‑ready documentation for FDA and AATB inspections.
- Maintained < 0.5% cumulative error across 280+ work orders, consistently producing specification‑compliant allografts that met all safety and regulatory standards.
- Advised the Sterilization group on process adjustments, integrating upstream processing insights to streamline the updated workflow.
- Applied hierarchical task analysis to triage daily priorities, maximizing productivity without compromising accuracy or compliance.
- Led and facilitated culture council meetings, developing guidelines for acceptable tissue quality, and updated training regimens to improve team performance, efficiency, stability, and long-term individual success.
Chemistry and Math Tutor
Varsity Tutors LLC And Self Employed
Effort, United States
11.2022 - 03.2024
- Built tailored learning plans and step‑by‑step study guides, later adopted by peer tutors.
- Logged session metrics to fine‑tune instruction and keep parents / faculty informed.
- Elevated student performance by up to 15% in general chemistry, organic chemistry, and calculus through targeted concept reviews and problem‑solving sessions.
Undergraduate Student Research Assistant
East Stroudsburg University of Pennsylvania
East Stroudsburg, United States
05.2022 - 08.2023
- Developed GLP‑compliant assays: designed fluorometric kinetic and inhibition methods (Michaelis–Menten, IC₅₀) that became the lab’s standard antitubercular platform and were featured in a peer‑reviewed publication.
- Produced & purified recombinant enzyme: performed transformation, plasmid prep, and high‑yield expression of Mycobacterium tuberculosis shikimate kinase (MtSK) in E. coli, followed by affinity‑chromatography purification (>95% purity, ≈ 20mg protein per L culture).
- Performed analytical HPLC: optimized C18 reverse‑phase methods to monitor avarone, its derivatives, and enzyme–inhibitor complex stability; chromatograms revealed shoulder peaks and a 40% drop in parent‑peak intensity over 24h, consistent with covalent MtSK modification.
- Characterized ligand binding & mechanism: substrate‑dependent fluorescence assays quantified MtSK affinities— K_D = 0.05 ± 0.01mM (shikimate), 0.12 ± 0.04mM (ATP)—and measured avarone binding (K_D = 0.26 ± 0.01mM).
- Linked target engagement to cellular activity: whole‑cell inhibition screens in Mycobacterium smegmatis showed avarone (IC₅₀ = 11.9 ± 0.01μM) and hymenidin (IC₅₀ = 15.9 ± 0.38μM) after 9h, validating low‑micromolar potency.
- Maintained routine biochemistry lab readiness—preparing buffers and media, calibrating pH meters and spectrophotometers, managing reagent inventory, and keeping GLP‑compliant records—to keep shared facilities running without interruption.
Summer Engineering Intern
Sanofi Pasteur
Swiftwater, Pennsylvania
05.2019 - 08.2019
- Restored vaccine‑inspection line: led end‑to‑end upgrade of a critical inspection machine, coordinating vendors, writing IQ/OQ protocols, and returning the line to 100% throughput with zero safety incidents.
- Delivered GMP projects: validated equipment changes and documented facility mods for FDA audits.
- Tightened lab monitoring by building a differential‑pressure sensor database for classified areas.
- Cut energy waste—drafted steam & chilled‑water P&IDs that drove a utilities‑plant redesign.
- Kept drawings audit‑ready: field‑verified 50+ P&IDs to current GMP standards.
- Modernized inspection labs: produced as‑built drawings and high‑capacity layouts for future growth.
- Indexed BAS records for 50+ buildings, slashing document search time during maintenance.
Microbiologist / Archaeology Assistant
University of Haifa
Tel Akko, Israel
05.2018 - 08.2018
- Performed sample characterization on > 300 archaeological isolates using bright‑field microscopy; recorded morphological details and compositional features with 98% data accuracy.
- Developed and curated a digital specimen repository, using Excel/Access relational tables to streamline data retrieval by 20%.
- Implemented standardized staining and batch‑labeling protocols, boosting sample throughput by 7% while maintaining full GLP compliance.
- Oversaw daily lab operations: calibrated pipettes, maintained microscopy equipment, managed chemical inventory, and supported general lab organization.
Summer Engineering Intern
Sanofi Pasteur
Swiftwater, United States
05.2017 - 08.2017
- Restored vaccine‑inspection line: led end‑to‑end upgrade of a critical inspection machine, coordinating vendors, writing IQ/OQ protocols, and returning the line to 100% throughput with zero safety incidents.
- Delivered GMP projects: validated equipment changes and documented facility mods for FDA audits.
- Tightened lab monitoring by building a differential‑pressure sensor database for classified areas.
- Cut energy waste—drafted steam & chilled‑water P&IDs that drove a utilities‑plant redesign.
- Kept drawings audit‑ready: field‑verified 50+ P&IDs to current GMP standards.
- Modernized inspection labs: produced as‑built drawings and high‑capacity layouts for future growth.
- Indexed BAS records for 50+ buildings, slashing document search time during maintenance.
Education
Bachelor of Science - Biochemistry And Chemical Biotechnology
East Stroudsburg University of Pennsylvania
East Stroudsburg, PA 01.2020 - 05.2023
Skills
Enzyme kinetics & fluorometric assay development
HPLC (C18 reverse-phase method optimization)
Recombinant protein expression & affinity purification
GLP / GMP documentation & regulatory compliance
Microscopy (bright-field) & tissue characterization
Sample preparation (tissue & environmental workflows)
Analytical troubleshooting & process validation support
Lab readiness: buffer/media prep & instrument calibration
Data analysis & scientific communication across cross-functional teams
Affiliations
American Association of Tissue Banks
American Chemical Society
Culture Team 24/25 - MTF Biologics
East Stroudsburg University S.T.E.M. Program Mentor
NADO Council (Standards Group) - AATB
Good Neighbors Committee - Scranton, PA
Tools/Software
Microsoft Excel / Access
GraphPad Prism
Swiss-Model (Expasy)
Spectrophotometry & pH meter calibration
PyMOL
Certification
Certified Tissue Bank Specialist
Timeline
Certified Tissue Bank Specialist
01-2025
Senior Process Technician
MTF Biologics
03.2024 - Current
Chemistry and Math Tutor
Varsity Tutors LLC And Self Employed
11.2022 - 03.2024
Undergraduate Student Research Assistant
East Stroudsburg University of Pennsylvania
05.2022 - 08.2023
Bachelor of Science - Biochemistry And Chemical Biotechnology
East Stroudsburg University of Pennsylvania
01.2020 - 05.2023
Summer Engineering Intern
Sanofi Pasteur
05.2019 - 08.2019
Microbiologist / Archaeology Assistant
University of Haifa
05.2018 - 08.2018
Summer Engineering Intern
Sanofi Pasteur
05.2017 - 08.2017