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Associate Director, Validation
Location:
The Woodlands, TX
Description:
"Bridging Innovation to Cure Developing and Manufacturing your cell therapies from benchtop to bedside" Summary Cellipont Bioservices is growing, and we are looking for a Associate Director, Validation who believe in the potential bridging clients discoveries to patient cures and who want to challenge the status quo and take Cellipont and it's clients to the next level. The Leader of Validation is responsible for overseeing and leading the Validation function. This individual will be responsible for developing and implementing the validation strategy and programs ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of cell therapies. This position plays a key role demonstrating the values, culture, and deliverables for the site. . The Role Responsible for staffing and overseeing training, effective execution of responsibilities, professional development of employees and conducting performance reviews Outlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success Responsible for all aspects of the Validation program, including equipment, utilities/facilities, aseptic simulation, computer system, cleaning, and process. Develop risk-based validation strategies, implement supporting policies and procedures. Responsible for representing validation during regulatory inspections and client audits. Strategy reviewer from a validation perspective, of quality system documents including, but not limited to CAPA, change control, non-conformances, etc. Maintain successful cross-functional relationships and facilitates validation support and works closely with other PCM functional units including Manufacturing, Quality Assurance, Facilities Engineering, and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured Manage external validation contract staff, as needed, ensuring accountability to deliverables according to service agreement. Ensures the timely completion of validation execution, applicable documentation to meet project objectives and deliverables Knowledgeable of current industry trends and regulatory requirements and guidelines as it relates to validation requirements Budgetary input for organization Ensure current Good Manufacturing Practices (cGMPs) compliance for manufacturing of biological product, and compliance to US and EU regulations, as applicable. Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements. Work with senior management to initiate new client proposals and projects. This includes analyzing client proposals for resource allocation and validation costs generated by Business Development. The Candidate Bachelor in a Life Science discipline required 10+ years of direct validation experience preferably in CDMO environment 5+ years' experience in direct people management Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance Knowledgeable and/or exposure to biological manufacturing processes, such as cell and gene therapy, vaccine, cell banking, and aseptic fill finish Exposure to contract manufacturing and facility build out is a plus. Ability to quickly learn new and novel manufacturing processes supporting new clients Ability to self-direct, and adapt to changing priorities Excellent communication and interpersonal skills required Strong attention to detail and organization skills required Proven technical writing and editing skills Creative individual with excellent problem solving and trouble shooting skills Ability to work effectively under pressure to meet deadlines Travel as needed up to 5% Position Benefits Opportunities for career growth within an expanding team Defined career path and annual performance review & feedback process Cross-functional exposure to other areas of within the organization Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members 401K strong employer match Tuition Reimbursement Employee Referral Bonuses Flexible work schedules based on role with 15 days of PTO annually, increasing 1 PTO day each year and paid holidays Gain experience in the cutting-edge cell therapy space "At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"
Company:
Cellipont Bioservices
Posted:
December 26 2023 on ApplicantPro
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More About this Listing: Associate Director, Validation
Associate Director, Validation is a Executive Associate Director Job at Cellipont Bioservices located in The Woodlands TX. Find other listings like Associate Director, Validation by searching Oodle for Executive Associate Director Jobs.
Associate Director, Validation is a Executive Associate Director Job at Cellipont Bioservices located in The Woodlands TX. Find other listings like Associate Director, Validation by searching Oodle for Executive Associate Director Jobs.