Laboratory Samples Manager
Contractor
Bristol, PA, USA
ABOUT
Clora's client is a biologics and bioconjugates CDMO with facilities across the US and UK. They are looking for a Laboratory Sample Manager who will be the accountable leader for all sample management within the Analytical Services department. This role directly manages 2 dedicated Sample Operations & Logistics Technicians — and is responsible for the performance, development, and day-to-day direction of those individuals. The manager sets the standards, builds the systems, and ensures both technician roles execute with consistency, compliance, and quality.
This is a player-coach role. The manager is expected to be deeply familiar with all aspects of the sample technician function — not as a backup, but as the subject matter leader who can identify gaps, resolve escalations, step in when needed, and continuously raise the bar.
The manager owns the strategy and governance of sample management, while the technicians own daily execution. Scope: This role oversees Sample Operations & Logistics, covering sample receipt, storage, inventory, shipping, third-party lab coordination, and CoA/standard management.
This is slated to be a long-term project and offers the potential for conversion from consultant to full-time employee depending on performance and if mutual interest is established.
Responsibilities
- Team Leadership, Development & Performance - Directly manage, mentor, and develop all Laboratory sample technicians; set clear expectations, provide regular feedback, and conduct formal performance reviews.
- Build individual development plans for each technician aligned with their role focus (Sample Operations) and career trajectory.
- Assign and prioritize workload across the team daily and weekly; anticipate bottlenecks and proactively redistribute work to ensure no operational task is missed or delayed.
- Serve as the escalation point for any issue either technician cannot resolve independently — whether a sample integrity concern, safety incident, equipment failure, or vendor dispute
- Strategic Oversight of Sample Operations & Logistics: Own the design and continuous improvement of all sample management SOPs — receipt, storage, chain of custody, retention, and disposal — ensuring they are current, compliant, and consistently followed.
- Establish storage condition standards and monitoring protocols for all sample categories (biologics, drug substance, raw materials, stability samples, reference standards); review and approve any deviations.
- Set the framework for third-party laboratory management. Oversee sample shipment operations. Define the CoA and reference/stability standard management system. Review and approve the stability trendsheet process. Conduct periodic QC reviews of the sample tracking database. Serve as the primary point of contact with clients, QA, and project teams.
- Cross-Functional Collaboration & Stakeholder Management: Serve as the primary operational liaison between the Laboratory Samples team and the Analytical Services scientific teams (Team Leads, Principal Scientists, Sr. Scientists). Attend project and department meetings. Partner with QA and QC to ensure laboratory operations meet quality system requirements. Collaborate with the PD, manufacturing, and supply chain teams on incoming sample expectations, material requirements, and shipment coordination.
- GMP Compliance, Quality Systems & Documentation: Ensure all Laboratory Sample Management Services are executed in full compliance with GMP requirements and internal quality standards. Own all Laboratory Sample SOPs.
- Continuous Improvement & Operational Excellence: Continuously evaluate the efficiency, reliability, and compliance of Laboratory Sample operations; proactively identify gaps and implement improvements before they become problems. Lead the implementation of new systems, tools, or technologies.
Ideal Background
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Biology, or a related field; advanced degree a plus.
- 8–10 years of progressive laboratory sample experience
- 3 years in a supervisory or management role with direct reports is preferred but not required
- Demonstrated experience managing laboratory samples in a GMP-regulated pharmaceutical or biotech environment — this is a firm requirement, not a preference.
- Hands-on experience across sample management/logistics
- Vendor and contract management experience.
- Excellent project management and organizational skills — able to manage multiple workstreams, deadlines, and stakeholders simultaneously.
- Strong interpersonal and communication skills; comfortable presenting to senior leadership.
- Player-coach mentality: able to set strategic direction while remaining operationally engaged and hands-on when the situation demands it.
- High standards for documentation quality, data integrity, and team accountability — leads by example in all of these areas.