Specialist, Global External Analytical Services
American Cybersystems, Inc.

Job Info

Innova Solutions is immediately hiring for a Global External Analytical Services Specialist (Manufacturing).

Job Title: Manufacturing
Position type: Full-time Contract
Duration: 12 Months
Location: Summit, NJ 07901 (Onsite)

As a Global External Analytical Services Specialist (Manufacturing), you will:
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.

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:
• 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

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Sara Almas
Team Recruitment
Sara.Almas@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay range: $32.00- $ 35.99 Per Hour.

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:
One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS
Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.