TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Quality Control Manager

A-22245-16044 H-1B 2023 Certified

Salary

$78,458

Visa Type

H-1B

Job Title

Quality Control Manager

Employee's Citizenship

INDIA

Graduate School

NORTHEASTERN UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22245-16044

Case Status Certified

Received Date 2022-09-05

Decision Date 2023-07-13

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name TAKEDA DEVELOPMENT CENTER AMERICAS, INC.

Employer Address_Line 1 95 HAYDEN AVE

Employer Address_Line 2 -

Employer City LEXINGTON

State -

Employer State/ Province MASSACHUSETTS

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 2421

Employer Phone No. 224-544-1749

Employer Phone Extent No. -

Total Number of Employees 19608

Employer Year of Commenced 2003

NAICS Code 325412

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Ken Brown

Employer Contact Address Line1 95 Hayden Ave

Employer Contact Address Line2 -

Employer Contact City Lexington

Employer Contact State/ Provice MASSACHUSETTS

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 2421

Employer Contact Phone 617-794-2549

Employer Contact Email ken.brown@takeda.com

Attorney

11 fields

Agent/ Attorney Name Susie Shin

Agent/ Attorney Firm Name Zulkie Partners LLC

Agent/ Attorney Phone (312) 831-2127

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 135 South La Salle Street

Agent/ Attorney Address Line 2 Ste. 3425

Agent/ Attorney City Chicago

Agent/ Attorney State/ Province ILLINOIS

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 60603

Agent/ Attorney Email sshin@zulkiepartners.com

Position Info

89 fields

Prevailing Wage Track Number P10021335735292

Prevailing Wage SOC Code 19-1029

Prevailing Wage SOC Title Biological Scientists, All Other

Prevailing Wage Skill Level Level II

Prevailing Wage 78458

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-06-06

Prevailing Wage Expiration Date 2022-09-04

Wage Offer From 87500

Wage Offer To 162500

Wage Offer Unit of Pay Year

Workstie Address Line 1 200 Shire Way

Worksite Address Line 2 -

Worksite City Lexington

Worksite State MASSACHUSETTS

Worksite Postal Code 2421

Job Title Quality Control Manager

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Biosciences or a related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study N

Accept Alternate Major -

Alternate Combination of Education/ Experience Y

Required Alternate Level of Education Master's

Other Alternate Level of Education -

Acceptable Years of Experience 4

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 72

Accept Alternate Job Title QC Specialist or rltd pstn

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Will accept any level of experience in the following skills Manage pharmaceutical projects for various biologics products in various product lifecycle phase from development to commercial; contract testing labs CTL, intern cross functional teams and colleagues to drive Takedas Biologics projects to timely completion while maintaining quality compliance; Serve as a Subject Matter Expert SME for analytical methods of bioassays including cellular uptake assays, Binding assays and immunoassays, support analytical method validation and transfer, follow pharmaceutical quality GMP compliance while meeting requirements as per United States Pharmacopeia ; European Pharmacopeia EP; and Japan Pharmacopeia and regulatory filings and submissions for agencies like United States Food and drug Administration, European Medicines Evaluation Agency, Japan Pharmaceuticals and Medical Devices Agency, Health Canada for Takedas Biologic product portfolio; Provide support of analytical method troubleshooting, problem solving root cause analyses via DMAIC process Define, measure, analyze, improve, and control and remediation of projects as and when needed; Experience in quality compliant technical writing; review and author documents like reports, protocols, memos etc. related to various analytical activities like method qualification, validation, and transfers; experience in technical writing to support regulatory filings like Investigational new drug application and New Drug Application; Experience in analytical method data trending, data analysis and interpretation using software like JMP, Minitab, Biostatistical analysis software like Stegmanns PLA Parallel Logistics Analysis and Molecular Device SoftMax Pro and Excel. 510 travel required.

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2022-06-24

Job Oder End Date 2022-07-26

Sunday Edition Newspaper Y

First Newspaper Name The Boston Globe

First Advertisement Start Date 2022-06-26

Second Newspaper Name The Boston Globe

Second Advertisement Type Newspaper

Second Ad Start Date 2022-07-03

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-06-24

Employer Website to Date 2022-08-02

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-06-27

Job Search Website to Date 2022-07-25

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2022-06-30

Local Ethnic Newspaper to Date 2022-06-30

Radio/TV Ad from Date -

Radio/TV Ad to Date -

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship INDIA

Foreign Worker Birth Country INDIA

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major BIOMEDICAL SCIENCE

Year of Compelted Education 2012

Foreign Worker Istitution of Eduation NORTHEASTERN UNIVERSITY

Foreign Worker Education Instution Address Line 1 300 HUNTINGTON AVENUE

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City BOSTON

Foreign Worker Educatution Institution State MA

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 2115

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience Y

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Susie Shin

Preparer Title Principal

Preparer Email sshin@zulkiepartners.com

Employer Information Declaration Name Ken Brown

Employer Declaration Title Global Mobility Strategy Lead