Fiscal Year

2020

Case Number

A-19106-93707

Case Status

Certified-Expired

Received Date

2019-04-15

Decision Date

2020-01-21

Refile

N

Original File Date

2020-01-01 07:13:51

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

DR. REDDYS LABORATORIES, INC.

Employer Name Slug

dr-reddys-laboratories-inc

Employer Address 1

107 COLLEGE ROAD EAST

Employer Address 2

Employer City

PRINCETON

Employer City Slug

princeton

Employer State

NEW JERSEY

Employer State Slug

new-jersey

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

8540

Employer Phone

6093759871

Employer Number of Employees

456

Employer Year Commenced Business

1992

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

ARIEL CONSOLINO

Employer Contact Address 1

107 COLLEGE ROAD EAST

Employer Contact Address 2

Employer Contact City

PRINCETON

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

8540

Employer Contact Phone

609-375-9871

Employer Contact Email

ACONSOLINO@DRREDDYS.COM

Agent Attorney Name

DAVID H NACHMAN

Agent Attorney Firm Name

NPZ LAW GROUP, P.C.

Agent Attorney Phone

201-670-0006 X100

Agent Attorney Address 1

487 GOFFLE ROAD

Agent Attorney Address 2

VISASERVE PLAZA

Agent Attorney City

RIDGEWOOD

Agent Attorney State/Province

NEW JERSEY

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

7450

Agent Attorney Email

DAVID_NACHMAN@VISASERVE.COM

PW Track Number

P10018163409787

PW SOC Code

11-3051

PW SOC Title

INDUSTRIAL PRODUCTION MANAGERS

PW Skill Level

Level IV

PW Wage

166442.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2018-09-28

PW Expiration Date

2019-06-30

Wage Offer From

222500.00

Wage Offer To

0.00

Average Salary

222500.00

Wage Unit of Pay

Year

Worksite Address 1

107 COLLEGE ROAD EAST

Worksite Address 2

Worksite City

PRINCETON

Worksite City Slug

princeton

Worksite State

NEW JERSEY

Worksite Postal Code

8540

Job Title

SR. DIRECTOR, TECHNICAL SERVICES & EXTERNAL MANUFACTURING

Job Title Slug

sr-director-technical-services-external-manufacturing

Minimum Education

Master's

Major Field of Study

PHARMACEUTICAL CHEMISTRY

Required Training

N

Required Experience

Y

Required Experience Months

120

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

N

Accept Alternative Occupation Months

Accept Alternative Job Title

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

SEE ATTACHMENTbr br ADDENDUMbr H. 14. SPECIFIC SKILLS OR OTHER REQUIREMENTSbr br MUST HAVE A MASTERS DEGREE IN PHARMACEUTICAL CHEMISTRY OR ITS U.S. EQUIVALENT. APPLICANT MUST HAVE AT LEAST 10 YEARS OF EXPERIENCE IN LEADERSHIP ROLES IN THE FIELD OF PHARMA TECHNICAL OPERATIONS. MUST HAVE HANDS ON EXPERIENCE WITH PHARMACEUTICAL DOSAGE FORMS LIKE CONVENTIONAL SOLID ORALS, COMPLEX SOLID ORALS, LIQUIDS, STERILE PRODUCTS, SEMISOLIDS, AND NOVEL FORMATS LIKE TRANSDERMAL PATCHES, FILMS, RINGS, INHALATIONS. IN DEPTH EXPERTISE ON MANUFACTURING TECHNOLOGY, EQUIPMENT AND PROCESSING CONTROLS DEPLOYED FOR MANUFACTURING OF SOLID ORALS AND STERILE PRODUCTS E.G. FLUID BED PROCESSORS, LYOPHILIZERS, ASEPTIC PROCESSING. EXTENSIVE EXPERIENCE INTERFACING WITH REGULATORY AGENCIES WITH SUCCESSFUL TRACK RECORDS IN HANDLING FDA, EU AND OTHER REGULATORY AGENCY INSPECTIONS. SOUND KNOWLEDGE OF APPLICABLE REGULATORY AND CGMP GUIDANCE SUCH AS ICH Q8, 9, 10, CFR 210, ETC. INCLUDING THE ABILITY TO APPLY THE GUIDELINES IN CONTEXT OF THE APPROPRIATE STAGE OF PRODUCT LIFE CYCLE. SOLID UNDERSTANDING OF QBD AND DOE PRINCIPLES AND EXPERIENCE APPLYING THESE PRINCIPLES INTO SUCCESSFUL PHARMACEUTICAL PROCESS DEVELOPMENT. DIRECT EXPERIENCE PLANNING AND EXECUTING PROCESS VALIDATION ACTIVITIES FOR MULTIPLE DOSAGE FORMS. ABILITY TO RESOLVE PRODUCT TECHNICAL ISSUES AND DESIGN RISK MITIGATION STRATEGIES FOR SUPPLY CONTINUITY. MUST HAVE EXCELLENT DATA ANALYSIS SKILLS AND THE ABILITY TO MAKE RECOMMENDATIONS THAT IMPACT THE SCIENTIFIC AND BUSINESS GOALS OF THE COMPANY; VENDORSUPPLIER MANAGEMENT SKILLS; AND EXCELLENT COMMUNICATION AND CROSSDEPARTMENT COLLABORATION SKILLS. KNOWLEDGE OF PHARMACEUTICAL PACKAGING OPERATIONS AND SERIALIZATION REQUIREMENTS AND PROFICIENCY WITH CONTROLLED SUBSTANCE DRUG PRODUCT DEVELOPMENT AND COMMERCIALIZATION. ABILITY TO ARTICULATE COMPLEX ISSUES AND IDEAS WITH CLARITY TO ENABLE UNDERSTANDING AND DIRECTION. STRONG ORAL AND WRITTEN COMMUNICATION SKILLS WITH EXPERIENCE IN WRITING SOPS, TECHNICAL REPORTS, AND RELATED DOCUMENTS, INCLUDING REGULATORY FILING DOCUMENTS. ABILITY TO WORK SUCCESSFULLY IN BOTH A TEAMMATRIX ENVIRONMENT AS WELL AS INDEPENDENTLY AND ABILITY TO INFLUENCE CROSSFUNCTIONALLY TO ENABLE IMPROVEMENTS AND PERFORMANCE THROUGHOUT DEVELOPMENT AND OPERATIONS, ARE ALSO 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

2018-10-30

SWA Job Order End Date

2018-12-03

Sunday Edition Newspaper

Y

First Newspaper Name

THE TIMES OF TRENTON

First Advertisement Start Date

2018-11-18

Second Newspaper Ad Name

THE TIMES OF TRENTON

Second Advertisement Type

Newspaper

Second Ad Start Date

2018-11-25

Employer Website From Date

2018-10-19

Employer Website To Date

2019-01-03

Professional Organization Ad From Date

2020-01-01 07:13:51

Professional Organization Advertisement To Date

2020-01-01 07:13:51

Job Search Website From Date

2018-11-18

Job Search Website To Date

2018-12-01

Employee Referral Program From Date

2018-11-01

Employee Referral Program To Date

2018-11-26

Local Ethnic Paper From Date

2020-01-01 07:13:51

Local Ethnic Paper To Date

2020-01-01 07:13:51

Radio/TV Ad From Date

2020-01-01 07:13:51

Radio/TV Ad To Date

2020-01-01 07:13:51

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

PHARMACEUTICAL CHEMISTRY

Foreign Worker Years of Education Completed

1993

Foreign Worker Institution of Education

UNIVERSITY OF PUNE

Foreign Worker Education Institution Address 1

BHARTI VIDYAPEETHS POONA COLLEGE OF PHARMACY

Foreign Worker Education Institution Address 2

ERANDAWANE

Foreign Worker Education Institution City

PUNE

Foreign Worker Education Institution State/Province

MAHARASHTRA

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

411038

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

Y

Preparer Name

Preparer Title

Preparer Email

Employer Information Declaration Name

ARIEL CONSOLINO

Employer Information Declaration Title

HUMAN RESOURCES MANAGER