Specialist, Global External Analytical Services - Eclaro

Summit, NJ

About the Job

Specialist, Global External Analytical Services
Job Number: 24-00595

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Specialist, Global External Analytical Services for our client in Summit, NJ.

Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

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.
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.

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.
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.

Required Qualifications:

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.
Bachelor’s Degree in Biochemistry, Cell Biology, Microbiology, Chemistry, Engineering or related areas.
3 or more year’s industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies.
Team player capable of working in cross functional teams.
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.

Preferred Experience:

Experience with analytical methods and / or laboratory operations related to viral vector manufacturing.
Experience working with Contract Testing Laboratories or External Suppliers.

If hired, you will enjoy the following Eclaro Benefits:

401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Source : Eclaro