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Case Number: A-23087-19591

Fiscal year: 2024

Fiscal Year

2024

Case Number

A-23087-19591

Case Status

Certified

Received Date

2023-03-28

Decision Date

2024-05-06

Refile

N

Original File Date

2024-01-01 01:17:42

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Takeda Manufacturing USA Inc.

Employer Name Slug

takeda-manufacturing-usa-inc

Employer Address 1

300 Shire Way

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

6177942549

Employer Number of Employees

19608

Employer Year Commenced Business

1994

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Ken Brown

Employer Contact Address 1

300 Shire Way

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

6177942549

Employer Contact Email

ken.brown@takeda.com

Agent Attorney Name

Susie Shin

Agent Attorney Firm Name

Zulkie Partners LLC

Agent Attorney Phone

3128312127

Agent Attorney Address 1

135 S. LaSalle Street

Agent Attorney Address 2

Suite 3425

Agent Attorney City

CHICAGO

Agent Attorney State/Province

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60603

Agent Attorney Email

sshin@zulkiepartners.com

PW Track Number

P10022153237056

PW SOC Code

19-1021

PW SOC Title

Biochemists and Biophysicists

PW Skill Level

Level IV

PW Wage

161221.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-12-19

PW Expiration Date

2023-06-30

Wage Offer From

162300.00

Wage Offer To

320600.00

Average Salary

241450.00

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

Director in Drug Product and Device Development Strategy

Job Title Slug

director-in-drug-product-and-device-development-strategy

Minimum Education

Bachelor's

Major Field of Study

Pharmaceutical Sciences, Clinical Pharmaceutical Sciences or related field or foreign academic equiv

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

216

Accept Alternative Job Title

Associate Director, Formulation Development or related position

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Required skills Develop formulations and manufacturing processes for various dosage forms including the analytical testing method development; manage internalexternal manufacturing organizations for clinical trial materials and commercial products; experience in communicating CMC strategy, tactics and resulting data with regulatory agencies such as FDA, EMA and PMDA by utilizing extensive knowledge of current Good Manufacturing Practices cGMP, ICH Guidelines, other pertinent national regulations, and compendial requirements; Demonstrate leadership on drug product and combination device project teams, influencing and guiding internal and external stakeholders to accomplish efficient and timely product pipeline transfers from CMC to commercial partners; demonstrate ability to identify technical, budgetary, and schedule risks for complex multidisciplinary programs and propose appropriate risk response strategies. Up to 25 travel required.

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

2023-01-13

SWA Job Order End Date

2023-02-14

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Sunday Globe

First Advertisement Start Date

2023-01-15

Second Newspaper Ad Name

Boston Sunday Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-01-22

Employer Website From Date

2023-01-13

Employer Website To Date

2023-02-22

Professional Organization Ad From Date

2024-01-01 01:17:42

Professional Organization Advertisement To Date

2024-01-01 01:17:42

Job Search Website From Date

2023-01-16

Job Search Website To Date

2023-02-13

Employee Referral Program From Date

2024-01-01 01:17:42

Employee Referral Program To Date

2024-01-01 01:17:42

Local Ethnic Paper From Date

2023-01-19

Local Ethnic Paper To Date

2023-01-19

Radio/TV Ad From Date

2024-01-01 01:17:42

Radio/TV Ad To Date

2024-01-01 01:17:42

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

JAPAN

Foreign Worker Birth Country

JAPAN

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

PHARMACEUTICAL SCIENCE

Foreign Worker Years of Education Completed

1997

Foreign Worker Institution of Education

OKAYAMA UNIVERSITY

Foreign Worker Education Institution Address 1

111 TSUSHIMA NAKA KITAKU

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

OKAYAMA

Foreign Worker Education Institution State/Province

CHUGOKU

Foreign Worker Education Institution Country

JAPAN

Foreign Worker Education Institution Postal Code

70085-30

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays 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 Information Declaration Title

Global Mobility Strategy Lead