Seeking Talent | Kyro BioPharma

Who do you want to hire?

Here is a detailed, comprehensive list of specialized skills and services Kyro BioPharma Solutions recruits for, with expanded descriptions and additional key capabilities relevant to the life sciences sector:

Quality Management System (QMS) Remediation

GAP Analysis: Identify deficiencies in existing quality systems relative to FDA, EMA, and global regulatory standards.
System Upgrades & End-to-End Remediation: Implement corrective actions, process improvements, and documentation updates to achieve and sustain compliance.
Inspection Readiness: Prepare organizations for regulatory inspections and audits.

Process Engineering

Design & Optimization: Develop and refine manufacturing and laboratory processes for efficiency, scalability, and compliance.
Troubleshooting: Address process deviations, bottlenecks, and yield issues.
Tech Transfer: Support the transfer of processes from R&D to commercial production.

MES Engineering

Implementation: Deploy and configure Manufacturing Execution Systems (MES) to manage production workflows.
System Integration: Ensure seamless connectivity between MES, ERP, and lab systems.
Support & Maintenance: Provide ongoing system optimization and troubleshooting.

Operations Management

Production Leadership: Oversee daily manufacturing operations, resource planning, and KPI tracking.
Continuous Improvement: Implement Lean, Six Sigma, and operational excellence initiatives.
Supply Chain Coordination: Manage procurement, inventory, and logistics.

Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT)

Test Protocol Development: Author and execute test plans for equipment and systems.
Validation Oversight: Ensure systems meet user and regulatory requirements before commissioning.

Mechanical, Electrical, and Software Engineering

System Design: Engineer new or upgrade existing mechanical, electrical, and software systems for manufacturing and laboratory environments.
Troubleshooting & Maintenance: Provide rapid response to system failures and support preventive maintenance.

Manufacturing, Science & Technologies (MSAT)

Process Development: Optimize production methods and scale-up processes.
Technical Transfer: Facilitate the transfer of products and processes between sites or from development to manufacturing.
Process Support: Resolve technical issues during manufacturing.

Quality Assurance (QA) and Quality Control (QC) Specialists

Batch Record Review: Ensure all production and testing documentation meets regulatory standards.
SOP & Technical Writing: Develop and maintain standard operating procedures and technical documents.
Analytical Testing: Conduct and oversee laboratory testing for product release and stability.
Deviation & CAPA Management: Investigate non-conformances and implement corrective actions.

Lyophilization Services

Validation: Develop and execute validation protocols for freeze-drying processes.
QMS Support: Integrate lyophilization into existing quality management systems.

GMP and cGMP Document Control

Document Management: Oversee creation, revision, approval, and archiving of controlled documents.
Records Retention: Ensure compliance with regulatory requirements for documentation.

Process Validation

Sterilization, Packaging, Cleaning Validation: Develop and execute validation protocols for critical manufacturing processes.
Lifecycle Management: Maintain validation status throughout product lifecycle.

Computer System Validation (CSV)

Compliance Assurance: Validate software and automated systems to meet 21 CFR Part 11 and other regulatory standards.
System Auditing: Perform periodic reviews and revalidations.

QC Lab Specialists—Biology and Chemistry

Analytical Testing: Perform chemical, biological, and microbiological assays.
Method Development: Develop and validate new analytical methods.

Construction Project Management

Clean Room & Facility Design: Plan, build, and qualify GMP-compliant manufacturing and laboratory spaces.
Project Oversight: Manage timelines, budgets, and contractor coordination.

Fill Finish / Packaging / Injectors (Auto and Semi-Automatic) FAT/SAT

Equipment Qualification: Lead FAT/SAT for fill-finish lines, packaging, and injector assembly.
Process Optimization: Enhance throughput and reliability of final dosage form production.

Facilities, Utilities, and Process Equipment

Engineering & Validation: Design, install, and qualify HVAC, water systems, and process equipment.
Maintenance Programs: Develop preventive maintenance and calibration schedules.

Automation/Computer Systems

Platform Expertise: Configure and support Delta V, Rockwell, Siemens, and PLC-based systems.
Integration: Connect automation systems with MES, LIMS, and ERP platforms.

Environmental Monitoring (EMPQ)

Program Development: Establish and maintain environmental monitoring programs for clean rooms and controlled environments.
Data Analysis: Interpret trends and respond to excursions.

Regulatory Strategies

Filing & Submissions: Prepare IND, NDA, ANDA, BLA, and CE Mark submissions.
Global Compliance: Advise on international regulatory requirements and market entry.

Pharmacovigilance and Biocompatibility

Safety Monitoring: Implement and manage adverse event reporting systems.
Regulatory Documentation: Prepare biocompatibility assessments and safety dossiers.

Audits and Compliance Professionals

Internal/External Audits: Conduct GMP, GLP, and GCP audits.
Post-Market Surveillance: Monitor product safety and performance in the market.
Inspection Support: Provide guidance during regulatory inspections.

Additional Skills and Roles We Recruit For

Data Integrity Specialists: Ensure ALCOA+ principles are maintained across all digital and paper records.
Clinical Operations & Trial Management: Oversee clinical trial execution, monitoring, and data management.
CMC (Chemistry, Manufacturing, and Controls) Experts: Manage CMC documentation and regulatory submissions.
Supply Chain & Logistics Specialists: Optimize procurement, warehousing, and distribution for regulated products.
Training & Learning Management: Develop and deliver GMP/cGMP training programs.
Technical Writers & Medical Writers: Prepare regulatory submissions, study reports, and SOPs.
Risk Management Professionals: Lead risk assessments (FMEA, HACCP) and mitigation planning.
Project Managers: Drive cross-functional teams to deliver complex projects on time and within budget.
IT & Cybersecurity for Life Sciences: Protect data and ensure compliance with regulatory IT standards.

Kyro BioPharma Solutions delivers specialized talent for every critical function in the life sciences, ensuring your organization remains compliant, innovative, and competitive. If you need expertise in any of these areas, contact us to learn how our tailored recruitment solutions can support your mission.

Kyro BioPharma Solutions Candidate Delivery Policy

Purpose

This policy outlines the principles and processes by which Kyro BioPharma Solutions delivers high-quality candidates and consulting personnel to support clients’ hiring and project needs. Our focus is on providing skilled professionals who contribute immediate value across projects spanning therapeutic biologicals, large and small molecule initiatives, and medical product development.

Our Commitment

Kyro BioPharma Solutions is committed to delivering candidates who meet the professional, technical, and cultural standards defined by our clients. We take a proactive, detail-oriented approach to each engagement and remain focused on delivering value through quality, speed, and integrity.

Candidate Delivery Process

Consultation & Role Definition
- We begin by working closely with your team to understand your goals, staffing challenges, and specific talent requirements.
- Job scopes, team dynamics, key deliverables, and timelines are defined to ensure targeted search efforts.
Candidate Identification & Screening
- We conduct targeted talent searches using a combination of direct outreach, internal networks, and proprietary sourcing tools.
- Every candidate is evaluated through structured interviews based on the role’s technical requirements, past experience, soft skills, and ability to adapt to the role's unique demands.
- Background checks, employment history verifications, and competency assessments are completed prior to any formal submission.
Candidate Submission & Feedback
- Candidates who meet the defined requirements are presented with a qualifications summary, outlining their relevant experience and key strengths.
- Clients can expect transparent, comprehensive profiles—presented in a format that allows for quick evaluation and decision-making.
- We coordinate interviews and collect structured feedback from clients and candidates throughout the process.
Selection & Onboarding Support
- Once a final selection is made, we facilitate the onboarding process to ensure a smooth transition.
- We support offer alignment, issue resolution, start date planning, and onboarding documentation to get candidates operational as quickly as possible.
Post-Placement Engagement
- We maintain contact with both clients and candidates after placement to ensure performance aligns with expectations.
- Regular check-ins allow us to identify any potential concerns early and ensure continued success.

Service Standards

Responsiveness: Every role or project is addressed with urgency and flexibility. Timely updates are provided throughout the lifecycle of the search.
Quality Over Volume: We prioritize precision. Only candidates who meet your specifications, both technically and culturally, are delivered.
Confidentiality: All information related to your business and any candidate discussions are treated with strict confidentiality.
Adaptability: We stay aligned with the evolving demands of your team. Whether your needs change during the delivery process or new requirements arise, we adjust quickly without compromising quality.

Continuous Improvement

We actively request client and candidate feedback after every placement or engagement. This enables us to refine processes continuously, remain aligned with expectations, and strengthen long-term collaboration.

Conclusion

Kyro BioPharma Solutions is more than a staffing provider—we are a strategic partner committed to helping your organization meet its goals through precise talent solutions. Our Candidate Delivery Policy ensures accountability, consistency, and performance in every engagement.