Job Summary

SUMMARY
The Director, Manufacturing Operations is responsible for the Manufacturing Operations of multiple laboratories involved in the development and analysis of current Good Laboratory Practice (cGLP) and current Good Manufacturing Practice (cGMP) compliant Cell & Gene Therapy (C&GT) products. As a subject matter expert (SME) on scientific and manufacturing matters, the position will work cross-functionally within Charles River Laboratories (CRL) Cell Solutions to commercialize and maintain new and current manufactured products. The position will also share in leadership roles within Cell Solutions at large as a member of the Extended Senior Leadership Team and promote advances to support customer needs in the C&GT space.

Essential Responsibilities

• Oversee the product life cycle from ideation, through GLP production and development, to GMP manufacturing via smooth cross-department collaboration, including technology transfers and constructive feedback processes.
• Provide supervision of the facility, equipment, and personnel. Ensure consistent laboratory presence and direct line-of sight with personnel in each directly-reporting department through daily lab walk-arounds and interaction with staff through regular huddles and lab group meetings weekly.
• Ensure that best industry practices are followed and areas for improvement are detected and timely acted upon. Work flows and processes should be mapped and undated to align with global practices as applicable. Assist direct reports to maximize productivity and efficiency while minimizing costs and downtime; monitor progress towards deliverables. Ensure capacity analysis is monitored monthly.
• Provide guidance on rapid resolution of audit findings and drive timely completions of deviations, CAPAs and change controls within the standard timeframe, and represent Manufacturing Operations in all resolution meetings internally and externally. 
• Provide technical support as needed for all laboratory operations including troubleshooting, product quality concerns, and resolution of customer issues.
• Oversee and ensure raw material inventory and warehouse supplies for the Site is maintained in support of routine production of GLP and GMP production against operation plans.
• Oversee training and competency of all reporting departments’ staff for completion in a timely and compliant  manner. Assist directly-reporting lab managers to design effective training programs and routines towards this goal. Ensure effective cross-department training and feedback is encouraged and incorporated by directly-reporting lab managers, leading to productive outcomes.
• Collaborate with financial staff and direct reports to develop and manage departmental budgets and resources and forecast revenue streams.
• Revise manufacturing, laboratory and operations SOPs to ensure compliance with regulatory frameworks.
• Assist directly-reporting staff with generation, review, and approval of documents in timely coordination with other departments.
• With support from directly-reporting laboratory managers, drive scientific innovation and manufacturing quality and efficiency including producing KPIs for maintaining optimal operational excellence and reporting to operations QMR.
• Design and execute scientific testing strategies and studies .
• Lead assay development, assay validations or study conduct, or is involved in preparation of material (e.g. protein, nucleic acid, cells, etc.).
• Review and interpret study data, communicate results to clients and write final reports.
• Troubleshoot and resolve assay or technical issues in the laboratory when scientific expertise is needed.

Essential Responsibilities (Cont.)

• Introduce new technologies or improvements in existing technologies. 
• Lead and provide guidance on development work, including process improvement, new technology implementation, new product development and other critical development strategies.
• Establish and oversee collaborations with external organizations to increase our current capabilities and improve internal processes and products.
• Provide leadership of troubleshooting studies and provide scientific oversight to ensure that appropriate experimentation is performed to yield scientifically sound results.
• Provide input to Senior Leadership Team, especially regarding general scientific and manufacturing affairs, with short- and long-term growth in mind.
• Attend and present at conferences approved by business head as an SME in manufacturing and/or C&GT matters, read scientific literature, study competition, customers, and industry trends to explore new revenue streams for consideration. 
• Assist with the research into new equipment, reagents, materials, etc.; provide support to staff to map onto existing manufacturing processed and/or develop around new manufacturing processes; evaluate appropriateness of characterization methods to obtain results.
• Interplay with external parties in support of issue resolution, complaints resolution, product strategies, and other collaborative efforts. Active participation on complaints committees and enlist involvement of direct reports as needed to respond timely.
• Assist Sales and Marketing staff with establishing pricing and full-time employee (FTE) requirement for short and long-term projects. Acts as a SME during project meetings and during site visits and audits.
• Share responsibility for products with directly-reporting laboratory managers and Product Management.
• Provide input to customers and other Business Units regarding project feasibility and deliverable(s); act in a technical support capacity and provide to internal and external stakeholders via consulting services.
• Provide feedback to departments and department heads on scientific, compliance, and production optimization and compliance.
• Perform other leadership responsibilities to support the needs of the directly-reporting departments, as applicable, but not limited to Warehousing, Inventory Control, Facilities and Equipment, Clinical Laboratory, Clean Room, Cell Isolation Laboratory, Shipping Logistics operations and Research and Development
• Provide data and metrics for Business review, QMR, track and report changes to Senior Management.

Supervisory Responsibilities

• This position has direct supervisory responsibilities
• Manage and direct both scientific and non-scientific staff.
• Build, retain, and lead multiple, collaborating teams.
• Foster a positive, productive, and collaborative work environment.
• Demonstrate use of excellent interpersonal, verbal, and written communication skills.
• Possess excellent relationship building skills, for both internal and external entities.
• Navigate and resolve internal staff issues.
• Develop staff via selection and discussion of novel concepts in cell biology and pharmaceutical manufacturing.
• Encourage leadership opportunities for future leaders withing CRL.
• Provide input to selection of new team members, promotions, and disciplinary measures.
• Author reviews of direct reports and assist with reviews of indirect reports.

Job Qualifications

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description.  The requirements listed below are representative of the knowledge, skills, and abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• High energy level and a positive outlook coupled with the requisite “can do’ attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• Willingness to seek perspective and ability to obtain consensus in the pursuit of adopting best practices.
• Ability to adapt to a constantly evolving environment.
• Ability to show discretion in handling confidential and sensitive matters.
• Tolerance for a fast-paced environment with minimal direction, and ability to adjust/delegate workload based upon changing priorities.
• Motivation and willingness to accept temporary responsibilities outside of initial job description.
• Time management skills and the ability to complete assignments and manage multiple projects concurrently to meet milestone timelines.
• Sound decision making/problem-solving skills. Able to apply critical thinking to problem solve while leveraging business needs.

Education, Experience, and Licensure

• M.S. or Ph.D. in Life Sciences disciplines, with 10+ years of relevant pharmaceutical/Cell Biology/ Immunology/biotechnology/ell and gene therapy industry experience. Ph.D. preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Minimum 5+ years of personnel management experience in industry setting.
• Experience with current Good Manufacturing Practices (cGMPs)/21 CFR210-211, 1271, FDA and EU C&GT requirements, USP ad ISO compliance; direct experience with in-person regulatory inspections/audits highly desired.
• Experience with downstream process analysis, development, and improvement.
• Experience designing and executing stability studies.
• Hands-on experience with cell and molecular biology and biochemical laboratory equipment techniques.
• Track record of processing large amounts of complex information and data to provide accessible summaries to other staff and managers.

Technical Skills

• Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.
• Ability to navigate, program, and interpret specialized environmental monitoring software.
• Ability to learn, operate, and interact with proprietary production scheduling and materials management software.
• Knowledge of modalities, services, and applications that can be integrated into current workflows for a positive effect and in a cost-effective fashion.
• Comprehension on basic and specialized laboratory equipment; ability to troubleshoot and make basic fixes in-place.

Language Skills 

• Must have a good command of the English language and be able to communicate clearly and concisely in both written and verbal format.  

Mathematical Skills

• Must be able to analyze and present complex quantitative data.  Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication, and percentages.
• Reasoning Ability 
• Must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise.  
• Must be able to resolve issues of a general and routine nature and exercise appropriate judgment to escalate issues to senior management.
• Must be able to effectively prioritize routine and nonroutine work assignments to ensure goals and timelines are met.

Physical Demands and Work Environment

• The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.
• Work is conducted in the Shipping, Laboratory, Donor Center, or standard office environment.  Temperatures are regulated by facilities management and are not within the direct control of the individual or company.  Most work is conducted in open areas with associated distractions such as noise from telephones, keyboards, machines, doorbells, and talking.
• Work performed in the Shipping, Laboratory, and Donor Center is done primarily while standing (6 to 8 hours a day). Work performed in the office environment is performed primarily while sitting (6 to 8 hours a day). All work environments utilize keyboards, gaze at a monitor(s), utilize hands to grasp, reach, and hold.  The employee must frequently lift or move up to 10 pounds over their shoulder and occasionally lift or move up to 50 pounds. Staff who works in the Shipping / Logistics or Warehouse departments may be required to lift or move more than 50 pounds while using proper safety equipment.
• Exposure to standard chemicals used in an office environment is expected. Additional exposure to Shipping, Laboratory, and Donor Room staff includes exposure to water, chemicals, bloodborne pathogens, waste, infectious material, dry ice, and liquid nitrogen.  Refer to the Safety Data Sheets for a complete list.
• Staff must wear Personal Protective Equipment (PPE) when performing tasks that may expose to bloodborne pathogens, waste, infectious material, dry ice, and liquid nitrogen or as required per policy.
• Employee must use proper safety equipment, as directed.

Compensation Data

The pay range for this position is $155,000/yr. – $207,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Competencies