Director, Technical Operations

Job description

For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.

We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work.

We believe in making a difference, and at Cell Solutions, you will make a difference every day.

**Job Summary**
The Director, Technical Operations is primarily responsible for providing technical oversight for operations functions within the organization.

The Director, Technical Operations works closely with the Medical Office in establishing donor safety as the highest priority for Cell Solutions and has oversight of the Donor center operations.

This role also works very closely with the Commercial Team to support new and existing revenue growth opportunities, feasibility on custom projects, technical operations and serving as a Subject Matter Expert (SME) for human starting materials procurement in support of cell and gene therapy clients.

As the SME for Technical Operations, the Director is responsible for ensuring compliance of all technical operations with applicable Standard Operating Procedures (SOPs), review of Quality Agreements, MSAs and SOWs for Commercial Team, regulatory agencies, and industry best practices.

Essential Responsibilities

+ Provides technical oversight of the HemaCare Donor Center (main areas of donor operations and donor recruitment)
+ Establishes with the guidance of the CS Medical Director(s) the Donor Center operations best practices and adjustments needed to meet regulatory requirements and also to best support commercial revenue generation.
+ In alignment with strategic goals and planning, plays a critical sponsorship role in multiple complex projects to drive revenue growth initiatives (eg.

Donor Room Operations/ Donor Base Optimization, Technical Operations, custom projects), working with Cell Solutions PMO office as needed, to ensure capabilities and resourcing meets client demands and leads the market and competition.
+ Serves on the Senior Leadership Team meetings to help set technical operations priorities and focus for Cell Solutions.
+ Ensures that all departments supervised provide high-quality customer service, follow safety guidelines and perform tasks in compliance with the company's quality program, SOPs, current Good Manufacturing Practices ('cGMP') and regulatory agencies and AABB guidelines.
+ Reports and investigate incidents, variances and complaints as outlined in the appropriate SOPs.
+ Supports customer and regulatory audits.

Reviews and approves error/accident reports, all related root cause analysis, corrective actions, preventive action and follow-up.

Provide appropriate guidance, direction and training to ensure effective resolutions.
+ Responsible, in collaboration with the Director, Manufacturing Operations, to ensure proper staffing capacity to fulfill on-going production needs resulting in timely revenue generation.
+ Develops and manages budget and resources for departments under his/her control.
+ Generates and analyzes reports regarding technical functions and KPIs.
+ Develops production/service or operations and resource plans that meet goals in terms of safety, quality, output, and cost.
+ Applies all applicable OSHA and related local safety requirements to all assigned work and ensures that the facility is within OSHA compliance
+ Perform additional duties as assigned

**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.

+ Experience with current Good Manufacturing Practices (cGMP's), current Good Tissue Practice (cGTP's), 1271 CFR, FDA and E.U. cell therapy requirements.
+ 5+ years' expertise in industry standard blood donor center operations including leukapheresis platforms preferred.
+ 5+ years' or more experience in revenue growth opportunities support with cell and gene therapy clients.
+ 5+ years' experience building relationships with various customers within academic, biotechnology, and/or pharmaceutical organizations.

Education, Experience, and Licensure

+ Minimum Bachelor's Degree in Biological, Chemical, Physical, or Medical Technology or Clinical Laboratory Science, or other technical field, or equivalent education and experience.
+ Blood collection/banking experience is highly desirable.

Technical Sales experience is a bonus.

Compensation Data
The pay range for this position is $190,000 - $210,000 per year.

Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

**About Charles River Cell Solutions**

Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development.

Cell Solution's vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections.

In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO).

Combined with Charles River's integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization.

Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market.

We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes.

Together, with over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges.

Our client base includes global pharmaceutical and biotechnology companies, government agencies, and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people's lives.

Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.

We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

At Cell Solutions, we are passionate about our role in improving the quality of people's lives.

We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies.

Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy.

This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone's life.

We're committed to providing benefits that elevate your quality of life.

Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

**Equal Employment Opportunity**
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com.

This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

230404

Required Skill Profession

Other General