Nehemias Guevara Mancia

Sample Management & Cryopreservation Associate
GMP-Regulated Biopharmaceutical Environment
• Managed receipt, accessioning, labeling, and documentation of patient samples, raw materials, and intermediates using LIMS, ensuring full traceability and compliance with GMP/GLP standards.
• Oversaw inventory control, tracking sample quantities, expiration dates, and storage conditions across ambient, refrigerated, frozen, and cryogenic environments.
• Executed cryopreservation and thawing of patient and clinical samples in alignment with SOPs, FDA/EMA guidelines, and regulatory requirements.
• Maintained cryogenic storage systems (LN2 freezers, dewars, cryovaults), ensuring material viability and chain of custody.
• Prepared, qualified, and shipped cryogenic shippers for domestic and international transport of clinical and commercial materials.
• Collaborated across manufacturing, supply chain, and quality teams to support end-to-end product flow and patient-specific timelines.
• Monitored equipment performance, performed routine maintenance and calibration, and responded to alarms to safeguard inventory.
• Upheld strict safety standards in cryogen handling, PPE, and hazard mitigation procedures.
• Supported continuous improvement initiatives to streamline cryo workflows, reduce errors, and increase operational efficiency.

Key Skills: Cryopreservation · Liquid Nitrogen Handling · Aseptic Technique · GMP Documentation · LIMS · FDA/EMA/ICH Compliance · CAPA/Deviation Reporting · Cross-Functional Collaboration · Attention to Detail · Patient-First Mindset

Key Responsibilities
• Operated, monitored, and troubleshot tablet compression machines to produce oral solid dosage forms in compliance with cGMP and SOPs.
• Executed pharmacy batch preparations, including weighing, dispensing, and verifying raw materials.
• Performed blending operations to achieve uniformity of pharmaceutical powders prior to compression.
• Completed and reviewed batch production records (BPRs) with accuracy to maintain data integrity and regulatory compliance.
• Conducted in-process checks (weight, hardness, friability, thickness) to ensure product quality and consistency.
• Collaborated with Quality Assurance and Maintenance to resolve deviations, equipment issues, and process variances.
• Followed safety and cleanroom protocols, including gowning, material handling, and equipment sanitization.
• Supported continuous improvement initiatives to optimize yields, reduce downtime, and enhance manufacturing efficiency.

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Skills & Competencies
• Technical Skills: Tablet compression, powder blending, pharmacy weighing/dispensing, cGMP, SOPs, batch record documentation.
• Quality & Compliance: In-process testing, deviation reporting, Good Documentation Practices (GDP).
• Soft Skills: Attention to detail, teamwork, problem-solving in fast-paced manufacturing environments.

Key Responsibilities
• Operated and maintained Swiss CNC machines to produce high-precision components for medical devices.
• Performed general stamping and lead frame fabrication for microelectronic and medical applications.
• Conducted in-process inspections using calipers, micrometers, and microscopes to ensure dimensional accuracy.
• Supported medical device manufacturing by assembling, handling, and packaging components under cleanroom and ISO standards.
• Followed detailed SOPs, work instructions, and quality control requirements to meet FDA and ISO 13485 regulations.
• Documented production data, completed batch records, and reported any deviations or equipment issues.
• Collaborated with engineering and quality teams to resolve production variances and improve process efficiency.
• Adhered to safety and Good Manufacturing Practices (GMP) while working with precision machinery and medical-grade materials.

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Skills & Competencies
• Technical: Swiss machine operation, stamping, lead frame production, medical device assembly, precision measurement tools.
• Compliance: GMP, ISO 13485, FDA regulations, cleanroom operations.
• Soft Skills: Attention to detail, teamwork, problem-solving in high-precision environments.