Job Summary:

The Senior Manager, Laboratory Operations is accountable for driving results in a fast-paced environment by providing leadership for the scientific, regulatory compliance and business functions for the Analytical Testing and Development Services Teams in our St. Louis, Missouri office. These teams focus on providing high quality services for compendial testing, method validation, and method development in a cGMP compliant and FDA-regulated facility. The Senior Manager, Laboratory Operations owns final responsibility for the success of site operations, achieving company goals, and serving as a client liaison.

On-Site Expectations:

• 100% on-site position.

Responsibilities:

• Provides scientific and business leadership to ensure the site’s performance meets the expectations of customers (internal and external) and supports the achievement of broader business goals.
• Develops site resource plans that meet company goals in terms of quality, safety, and productivity metrics.
• Provides significant strategic input on growth strategies for the business and expansion of scientific capabilities and services.
• Formulates and implements policies that meet compliance and operational expectations.
• Participates in meetings with clients and potential clients to define projects and plays an important role in expansion of the business with current clients and prospects.
• Responsible for staff selection, development, and performance management. Builds high performing team that delivers outstanding scientific, quality productivity results.
• Oversees lab investigations and drives continuous improvement.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Other duties as assigned.

Qualifications:

• Bachelor’s or Master’s degree in a science-related field with 8 years of pharmaceutical laboratory experience that includes management and leadership responsibility.
• Experience in a CDMO/CMO environment strongly preferred.
• 8 years’ experience in a Chemistry lab in the pharmaceutical or biotech industry with 3-5 years of that experience in a leadership role.
• Strong understanding of pharmaceutical analytical Chemistry testing.
• Experience with inspections/audits by regulatory agencies and clients.
• Root Cause Investigation experience.

Knowledge, Skills, and Abilities:

• Excellent leadership skills.
• Able to work effectively with staff, peers, customers, and regulatory agencies.
• Ability to develop productive professional relationships and a strong customer-focus.
• Ability to manage multiple, sometimes competing priorities while maintaining site performance.
• Strong understanding of Pharmaceutical Microbiology and Analytical Chemistry testing and quality principles as applied to a cGMP environment.
• Excellent project management skills; a strategic and results-oriented approach to operational excellence.
• Strong organization and management skills required.
• Record of accomplishment in change management and proven ability to build teams and enhance business and scientific results.
• Self-motivated with high-energy and an entrepreneurial team spirit, willing to get “hands on” to build the business.
• Excellent written and verbal communications and presentation skills required.
• Proficiency with Microsoft Office (Word, Excel, and PowerPoint) required.

Travel Expectations:

• Up to 10% travel required.

Physical Demands and Work Environment:

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

The noise level in the work environment is usually quiet with periods of higher noise elevations when present in warehouse or manufacturing areas. The employee may be required to gain access to lab personnel via general lab or manufacturing areas only for work discussions or follow-up or be required to tour clients through the various facilities. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.