What are the responsibilities and job description for the Validation - Project Manager position at On-Board Companies?
On-Board Scientific is hiring a Validation - Project Manager (Bilingual Japanese/English preferred) based out of Summit, NJ!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: 6-month contract with additional opportunity contingent upon performance and continued business needs.
Job Location: Summit, NJ
Shift: 1st shift
Compensation: $67.83-$73.48 per hour (based on experience)
Key Aspects:
50% onsite
Work hours are Monday-Friday - needs to be flexible to meet Japan timings
Bilingual Japanese/English is a plus
This position is accountable for the end-to-end management for method transfers & validations for the Cell Therapy Organization for late-phase and commercial products. This position also manages post-transfer life cycle activities to support Cell Therapy Drug Product Programs. Other accountabilities might be included for the same role based on the project assignation and team needs.
Responsibilities:
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 24-01713
INDOJ
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: 6-month contract with additional opportunity contingent upon performance and continued business needs.
Job Location: Summit, NJ
Shift: 1st shift
Compensation: $67.83-$73.48 per hour (based on experience)
Key Aspects:
50% onsite
Work hours are Monday-Friday - needs to be flexible to meet Japan timings
Bilingual Japanese/English is a plus
This position is accountable for the end-to-end management for method transfers & validations for the Cell Therapy Organization for late-phase and commercial products. This position also manages post-transfer life cycle activities to support Cell Therapy Drug Product Programs. Other accountabilities might be included for the same role based on the project assignation and team needs.
Responsibilities:
- Manage commercial and late phase DP method lifecycle activities across a multi-product portfolio (methods for release and in-process controls in scope)
- Operational management lead for the implementation of method lifecycle and method maintenance programs to support cell therapy methods (drug product or as applicable).
- End to end management for method transfer & validation activities at contract test sites and internally
- Create project plans using PM softwares, develop, and update timelines, monitor and document progress, identify risks to project deliverables, establish and coordinate mitigation plans, lead meetings and document outcomes (meeting minutes).
- Using visual and analytical tools to communicate progress to direct report and to cross-functional teams and lead governances. Creates meeting minutes, project trackers, action & risk logs, Bill of Materials, master tables and all necessary tools to proactively an efficiently leading the project towards success.
- Coordinate internal cross-functional team members on project deliverables to maintain overall project timelines
- Develop and implement proactive initiatives towards efficiency
- Support related change controls.
- Liaise with internal and external technical experts
- This role may involve E2E management for DP release/in process establishment including coordination for planning and execution of bridging or Justification for specifications supporting cross-functional functions (as project R&R require).
- Function as the Quality liaison with contract test labs during QC investigations
- Represent the Cell therapy Analytical Sciences and Technology department on cross-functional drug product teams.
- BS/MS in relevant scientific discipline and 2 years (or equivalent combination) experience within a regulated (GMP) biopharmaceutical, cellular therapy, or gene therapy organization.
- Experience in management of external contract testing is preferred.
- Knowledge of analytical method lifecycle, including assay qualification, transfer, validation and maintenance. Experience with implementing release methods in a commercial QC facility.
- Experience in cGMP regulations and application within the Quality Control environment.
- Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, vaccines and/or biological products.
- Strong technical writing experience (general QC lifecycle management procedures) is required.
- Excellent verbal and written communication skills.
- Must possess effective time management and cross-functional communication skills, demonstrate initiative, resourcefulness, and flexibility to work independently and as part of a team.
- Ability to work effectively at a fast pace and with tight timelines. Comfortable with changing priorities and managing multiple projects.
- Ability to prioritize work independently
- Ability to influence, facilitate alignment and communicate as appropriate.
- Ability to identify risks and proactively develop mitigation plans
- Comfortable working in a multi-cultural environment
- Project Management experience (min 2 years) (PMP certificate or proven experience)
- Fluent management for PM tools such as Smartsheet, Microsoft Time Pro, Microsoft Project Plan or others.
- Experience with project status communication (visual, verbal, writing)
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD# 24-01713
INDOJ
Salary : $68 - $73
