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Specialist, Global External Analytical Services - Summit, NJ / Devens, MA 2 positions
12 month contract
W2 Payrate: $33.00 - $35.90/hr
100% onsite
PURPOSE AND SCOPE OF POSITION:
The Specialist, Global External Analytical Services is responsible for sample submissions and test status tracking of analytical testing performed at Contract Test Laboratories (CTLs). This role is accountable for generating CTL sample submission forms, sample shipment tracking, test status oversight and maintaining related daily updates to our internal sample tracker in a timely manner. In addition, this role will provide support to Global External Analytical Services, External Relationship Managers (ERMs) and assist with CTL related issues remediation, tracking and escalations on an as needed basis.
This role may also partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Manufacturing Science & Technology (MS&T), Analytical Science & Technology (AS&T), Supply Chain (SC), and teams within Vector External Manufacturing Quality to support activities related to release of commercial vector in a timely manner.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Excellent organizational skills and detail-oriented, including ability to manage a large volume of sample submissions across multiple CTLs and complete routine/daily sample tracking updates in electronic tracking systems.
• Excellent verbal and written communication skills, and ability to work in an inter-disciplinary and cross-functional team.
• Ability to follow assignments through to completion in a consistent and accurate manner.
• Ability to work in a high paced environment, meet deadlines, prioritize and escalate issues from multiple projects/samples/CTLs, with direction from ERMs and/or Manager.
• With oversight from manager and/or ERMs, think strategically and understand global impact of analytical testing issues included but not limited to testing delays at CTLs.
Education and Experience:
• Required Bachelor’s degree in biochemistry, cell biology, microbiology, chemistry, engineering or related areas.
Experience:
• 3 or more years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies
• Experience with analytical methods and/or laboratory operations related to viral vector manufacturing is preferred
• Experience working with Contract Testing Laboratories or External Suppliers is preferred
• Established communication and organizational skills
• Team player capable of working in cross functional teams
• Strong verbal and written communication skills
• Strong knowledge of computer software including MS Office applications (i.e Excel, QuickBase, Outlook etc.)
• Ability to work effectively in a fast-paced matrixed environment
DUTIES AND RESPONSIBILITIES:
• Active team member in the Virtual Analytical Teams (VATs) including collaboration with External Relationship Managers (ERMs)
• Work closely with Global Product Quality, External Manufacturing, and Supply Chain to understand forecasts and deadlines to ensure timely CoA/CoT (Certificate of Analysis/Certificate of Testing) generation for Cell Therapy vector products
• Conduct weekly meetings with Contract Test Labs (CTL) to provide testing forecast, generate sample submission, provide shipping details to CMO, tract testing status and be point of contact for any test status question in collaboration with ERMs.
• Work cross functionally to provide single point of contact for CTL sample management to internal teams and external manufacturing partners, as needed
• With support from Manager and/or ERMs, provide guidance and directions to external laboratories and communicate within internal teams on testing activities at CTLs
• Lead virtual meetings related to analytical testing status with CTLs
• Escalate issues and/or delays related to CTL testing in a timely manner
• Assist ERMs with CTL issues resolution, as needed
• Other External Analytical Services responsibilities as needed/assigned
Opportunity is Calling, Apply Now!
What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, 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, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Company Description12 month contract
W2 Payrate: $33.00 - $35.90/hr
100% onsite
PURPOSE AND SCOPE OF POSITION:
The Specialist, Global External Analytical Services is responsible for sample submissions and test status tracking of analytical testing performed at Contract Test Laboratories (CTLs). This role is accountable for generating CTL sample submission forms, sample shipment tracking, test status oversight and maintaining related daily updates to our internal sample tracker in a timely manner. In addition, this role will provide support to Global External Analytical Services, External Relationship Managers (ERMs) and assist with CTL related issues remediation, tracking and escalations on an as needed basis.
This role may also partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Manufacturing Science & Technology (MS&T), Analytical Science & Technology (AS&T), Supply Chain (SC), and teams within Vector External Manufacturing Quality to support activities related to release of commercial vector in a timely manner.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Excellent organizational skills and detail-oriented, including ability to manage a large volume of sample submissions across multiple CTLs and complete routine/daily sample tracking updates in electronic tracking systems.
• Excellent verbal and written communication skills, and ability to work in an inter-disciplinary and cross-functional team.
• Ability to follow assignments through to completion in a consistent and accurate manner.
• Ability to work in a high paced environment, meet deadlines, prioritize and escalate issues from multiple projects/samples/CTLs, with direction from ERMs and/or Manager.
• With oversight from manager and/or ERMs, think strategically and understand global impact of analytical testing issues included but not limited to testing delays at CTLs.
Education and Experience:
• Required Bachelor’s degree in biochemistry, cell biology, microbiology, chemistry, engineering or related areas.
Experience:
• 3 or more years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies
• Experience with analytical methods and/or laboratory operations related to viral vector manufacturing is preferred
• Experience working with Contract Testing Laboratories or External Suppliers is preferred
• Established communication and organizational skills
• Team player capable of working in cross functional teams
• Strong verbal and written communication skills
• Strong knowledge of computer software including MS Office applications (i.e Excel, QuickBase, Outlook etc.)
• Ability to work effectively in a fast-paced matrixed environment
DUTIES AND RESPONSIBILITIES:
• Active team member in the Virtual Analytical Teams (VATs) including collaboration with External Relationship Managers (ERMs)
• Work closely with Global Product Quality, External Manufacturing, and Supply Chain to understand forecasts and deadlines to ensure timely CoA/CoT (Certificate of Analysis/Certificate of Testing) generation for Cell Therapy vector products
• Conduct weekly meetings with Contract Test Labs (CTL) to provide testing forecast, generate sample submission, provide shipping details to CMO, tract testing status and be point of contact for any test status question in collaboration with ERMs.
• Work cross functionally to provide single point of contact for CTL sample management to internal teams and external manufacturing partners, as needed
• With support from Manager and/or ERMs, provide guidance and directions to external laboratories and communicate within internal teams on testing activities at CTLs
• Lead virtual meetings related to analytical testing status with CTLs
• Escalate issues and/or delays related to CTL testing in a timely manner
• Assist ERMs with CTL issues resolution, as needed
• Other External Analytical Services responsibilities as needed/assigned
Opportunity is Calling, Apply Now!
What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, 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, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Founded in 1940, Yoh operates from 75 locations throughout North America and is headquartered in Philadelphia, PA. Yoh was the nation’s first technology staffing firm. As a business unit of Day & Zimmermann, Yoh has a flourishing global footprint, as our parent company operates from more than 150 worldwide locations.
Company Website: https://www.yoh.com/
Company Website: https://www.yoh.com/
