Manufacturing - Specialist, Global External Analytical Services Specialist - Sunrise Systems Inc

Job Title: Manufacturing - Specialist, Global External Analytical Services
Job ID: 24-00890
Location: Summit NJ/Devens MA
Duration: 12 Months contract on W2

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

WORKING CONDITIONS (US Only):

• Required to work in office environment.
• Sitting, standing, and computer work is required.
• Ability to participate in conference calls.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
• There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
• Employees holding this position will be required to perform any other job-related duties as requested by management.

Contact

Satya | Direct: (732) 2720262 | Email: satya@sunrisesys.com | URL: www.sunrisesys.com