Lab Operations Manager - Analytical Chemistry - Nelson Laboratories Holdings, LLC

The Lab Operations Manager is primarily focused on the business oversight of the chemistry departments and day-to-day operations, with a focus on operational oversight and continuous process improvement. The successful candidate will have a background in pharmaceutical testing, method development and validation. Candidate will have successful track record of people development and leadership. This role will also require an individual who can establish strong client relationships to grow the business. The successful candidate will have a strong working knowledge of guidelines, regulatory considerations, etc. and the personal integrity to uphold these at all times.

Essential Duties:

Chemistry Leadership

• Manage Residual Ethylene Oxide (EO) analysis, Total Organic Content residual analysis (TOC), and other required testing for medical devices (excluding Microbiology).
• Act as study director, consulting with customers, designing protocols, and approving medical device studies.
• Lead method development and validation for small molecule API and drug products.
• Lead phase-appropriate method development and validation or method transfer to support early-phase clinical development to commercialization.
• Author/review documentation to support new and existing commercial products (methods, SOPs, transfer protocols/reports, lab notebooks, technical reports, etc.).
• Lead analytical OOS/OOT investigations and assist process investigations.
• Review analytical raw data and result reports, including release and stability data.

People Leadership

• Ensure your team works safely and participates in company safety initiatives.
• Independently lead the chemistry team (Lab analysts, R&D chemists & QC Chemists), ensuring effective integration and coordination among team members with a focus on results against targets and objectives.
• Foster individual learning and development. Develop team's technical and leadership capabilities; mentor and prepare for future leadership roles.
• Actively work to build a sense of trust with direct reports, including regular feedback, one-on-one meetings, etc. Foster a sense of belonging to the team, strong camaraderie, and tightly-knit cross-functional working relationships.
• Constantly engage employees through clear communication and connection to the organization's mission of Safeguarding Global Health®.

Customer Focus

• Work cross-functionally with the Sales and Consulting teams to grow the business offerings of your laboratory and increase profitable volume growth.
• Ensure strong service delivery (turnaround times) and that the Nelson Labs service standard is known and practiced.
• Act as a key contact with the client to define the scope of work, deliverables, turnaround time, and quality requirements.
• Intervene as required to address escalated client issues.

Personal and Organizational Integrity

• Lead the effort to improve and maintain the quality of services by trending quality issues and by developing action plans with the Quality Assurance Department and employees.
• Preserve the company's focus on data and personal integrity. Ensure regulatory compliance is maintained.
• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
• Know and follow company policies and procedures.
• Complete required training on time.

Operational Excellence

• Lead tracking and improvement of the department's key performance indicators (commercial data collection, interpretation, review, trends, utilization, etc.) and objectives in accordance with Nelson Labs' performance goals. Generate reports to support continuous process verification.
• Understand and manage business unit P&L, budget and financial metrics.
• Plan for business resources, personnel, and CapEx using financial models and ROI.
• Maintain and monitor production metrics in accordance with NL performance goals.
• Optimize testing workflow across departments and ensure resources and personnel are adequate to accomplish the work in process and to meet business needs with client expectations for delivery and service.
• Work on continuous improvement to increase efficiencies and reduce waste.
• Manage and control expenditures within agreed-upon budgets.
• Manage utilization and key production metrics with visibility to staff
• Oversee the development and execution of the section training program to ensure resource availability and business continuity
• Manage and forecast the supply chain to minimize or eliminate testing interruptions.

Competencies of this position:

• Strong people orientation: demonstrated management capability and a committed team player.
• Ability to work successfully in both a team/matrix environment as well as to work independently.
• Ability to work in a fast-paced environment, manage priorities and organize a time to stay on schedule.
• Good communication skills in live presentations and in writing technical reports.
• Problem-solving; ability to solve complex employee, technical, and customer challenges.
• Must work cross-functionally and disseminate ideas across discipline and project boundaries.
• Able to teach others scientific theory/application.
• Influence skills with staff at all levels of the organization.

Work Environment:

This job operates in a professional office and lab environment. This role routinely uses standard office equipment. This role routinely enters into the lab to perform work.

Physical requirements:

The physical demands described here must be met to perform the essential job functions. Must be able to move/traverse 10% of the day and remain in a stationary sitting/standing position at a desk while using standard office equipment for 90% of the day. This position does not require heavy lifting greater than 50 lbs..

Education and experience requirements:

• 4+ years of relevant management experience required in Chemistry, Biochemistry, Pharmaceutical Chemistry, or other natural science
• Education levels:
  • Bachelor's degree and eight years experience in Production Laboratory Testing environment
    • OR
  • Masters and six years experience in Production Laboratory Testing environment
    • OR
  • Ph.D. and four years experience preferred in Production Laboratory Testing environment
• Working Experience:
  • Pharmaceutical industry experience, particularly parenteral products required. Additional medical device industry is a plus.
  • Analytical expertise in small-molecule drug substance and drug product, release and stability studies.
  • Analytical development or technical operations role, supporting new product development and commercialization.
  • Chromatographic expertise and techniques such as HPLC, IC, GC, and other standard analytical techniques used in pharmaceutical analysis.
  • Familiarity with compendial (USP, EP) procedures for analysis in support of Container/Closure, Raw Materials, API , and Drug product testing
• Knowledge of cGMPs, ICH guidelines, and associated CMC regulatory considerations in a pharmaceutical setting. Knowledge of ISO 10993-18 and ISO 19227 for medical device product testing preferred.
• Problem-solving/root-cause analysis for analytical-related issues.