All Details of Green Card Application:
Explore Trends, Employment Opportunities, and Insights
Case Number: A-21265-48251
Fiscal year: 2022
Fiscal Year
2022
Case Number
A-21265-48251
Case Status
Certified-Expired
Received Date
2021-09-23
Decision Date
2022-03-28
Refile
N
Original File Date
2022-01-01 11:10:00
Previous SWA Case Number State
Schedule A Sheepherder
N
Employer Name
TAKEDA DEVELOPMENT CENTER AMERICAS, INC.
Employer Name Slug
takeda-development-center-americas-inc
Employer Address 1
95 HAYDEN AVE
Employer Address 2
Employer City
LEXINGTON
Employer City Slug
lexington
Employer State
MASSACHUSETTS
Employer State Slug
massachusetts
Employer Country
UNITED STATES OF AMERICA
Employer Postal Code
2421
Employer Phone
224-544-1749
Employer Number of Employees
18000
Employer Year Commenced Business
2003
NAICS Code
325411
FW Ownership Interest
N
Employer Contact Name
Paul Lambert
Employer Contact Address 1
95 Hayden Ave
Employer Contact Address 2
Employer Contact City
Lexington
Employer Contact State/Province
MASSACHUSETTS
Employer Contact Country
UNITED STATES OF AMERICA
Employer Contact Postal Code
2421
Employer Contact Phone
224-544-1749
Employer Contact Email
paul.lambert@takeda.com
Agent Attorney Name
Susan M MacLean
Agent Attorney Firm Name
Zulkie Partners LLC
Agent Attorney Phone
(312) 831-2129
Agent Attorney Address 1
135 S. La Salle Street
Agent Attorney Address 2
Suite 3425
Agent Attorney City
Chicago
Agent Attorney State/Province
ILLINOIS
Agent Attorney Country
UNITED STATES OF AMERICA
Agent Attorney Postal Code
60603-4177
Agent Attorney Email
smaclean@zulkiepartners.com
PW Track Number
P10021039062187
PW SOC Code
13-1041
PW SOC Title
Regulatory Affairs Specialist
PW Skill Level
Level IV
PW Wage
100880.00
PW Unit of Pay
Year
PW Wage Source
OES
PW Determination Date
2021-06-25
PW Expiration Date
2021-09-23
Wage Offer From
101000.00
Wage Offer To
157300.00
Average Salary
129150.00
Wage Unit of Pay
Year
Worksite Address 1
35 Landsdowne Street
Worksite Address 2
Worksite City
Cambridge
Worksite City Slug
cambridge
Worksite State
MASSACHUSETTS
Worksite Postal Code
2139
Job Title
Good Manufacturing Practice Quality Program Manager
Job Title Slug
good-manufacturing-practice-quality-program-manager
Minimum Education
Bachelor's
Major Field of Study
Chemistry, Biology, Engineering, Regulatory Affairs or related field
Required Training
N
Required Experience
N
Required Experience Months
Accept Alternative Field of Study
N
Accept Alternative Major Field of Study
Accept Alternative Combination
N
Accept Alternative Combination Education
Accept Alternative Combination Education Years
Accept Foreign Education
Y
Accept Alternative Occupation
Y
Accept Alternative Occupation Months
72
Accept Alternative Job Title
Quality Assurance Supervisor or related occupation
Job Opportunity Requirements Normal
N
Foreign Language Required
N
Specific Skills
Prior experience must include at least 6 years of experience with each of the following Oversee and conduct final release and product disposition of Commercial and Clinical Trial GMP Material Drugs, Biologics, Small molecule etc. for use per Code of Federal Regulations 21CFR, ICH and other regulatory agency requirements; independently perform Root Cause Analysis and write, review and lead deviation investigations, Change controls, CAPA, nonconformance, Complaints and related technical quality system documentation for compliance to regulatory requirements; provide quality and compliance support by conducting and supporting QualityRegulatory audits, generating Quality Agreements, coordinating with QPs for product release and participating in CMCCMO meetings to ensure product development per cGMP needs; review and approve analytical test method protocols, Scaleup Process Validation reports, Master Executed Batch Records, Test Specifications and Stability studies reports.
Combination Occupation
N
Offered to Applicant Foreign Worker
Y
Foreign Worker Live on Premises
N
Foreign Worker Live in Domestic Service
N
Foreign Worker Live in Domestic Service Count
Professional Occupation
Y
Application for College/University Teacher
N
SWA Job Order Start Date
2021-07-23
SWA Job Order End Date
2021-08-23
Sunday Edition Newspaper
Y
First Newspaper Name
The Boston Globe
First Advertisement Start Date
2021-07-25
Second Newspaper Ad Name
The Boston Globe
Second Advertisement Type
Newspaper
Second Ad Start Date
2021-08-01
Employer Website From Date
2021-07-23
Employer Website To Date
2021-08-23
Professional Organization Ad From Date
2022-01-01 11:10:00
Professional Organization Advertisement To Date
2022-01-01 11:10:00
Job Search Website From Date
2021-07-25
Job Search Website To Date
2021-08-23
Employee Referral Program From Date
2022-01-01 11:10:00
Employee Referral Program To Date
2022-01-01 11:10:00
Local Ethnic Paper From Date
2021-07-29
Local Ethnic Paper To Date
2021-07-29
Radio/TV Ad From Date
2022-01-01 11:10:00
Radio/TV Ad To Date
2022-01-01 11:10:00
Employer Received Payment
N
Posted Notice at Worksite
Y
Layoff in Past Six Months
N
Country of Citizenship
INDIA
Foreign Worker Birth Country
INDIA
Class of Admission
H-1B
Foreign Worker Education
Master's
Foreign Worker Information: Major
REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS MEDICAL DEVICES
Foreign Worker Years of Education Completed
2013
Foreign Worker Institution of Education
NORTHEASTERN UNIVERSITY
Foreign Worker Education Institution Address 1
360 HUNTINGTON AVENUE
Foreign Worker Education Institution Address 2
Foreign Worker Education Institution City
BOSTON
Foreign Worker Education Institution State/Province
MA
Foreign Worker Education Institution Country
UNITED STATES OF AMERICA
Foreign Worker Education Institution Postal Code
2115
Foreign Worker Experience with Employer
N
Foreign Worker Employer Pays for Education
N
Foreign Worker Currently Employed
Y
Employer Completed Application
N
Preparer Name
Susan M MacLean
Preparer Title
Attorney
Preparer Email
smaclean@zulkiepartners.com
Employer Information Declaration Name
Paul Lambert
Employer Information Declaration Title
Global Mobility Manager