The Global Alliance for TB Drug Development

Chemistry, Manufacturing, & Controls (CMC) Project Manager

A-22237-11739 H-1B 2023 Certified

Salary

$121,118

Visa Type

H-1B

Job Title

Chemistry, Manufacturing, & Controls (CMC) Project Manager

Employee's Citizenship

INDIA

Graduate School

ANDHRA UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-22237-11739

Case Status Certified

Received Date 2022-09-07

Decision Date 2023-07-28

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 The Global Alliance for TB Drug Development

Employer Address_Line 1 40 Wall Street

Employer Address_Line 2 24th Floor

Employer City New York

State -

Employer State/ Province NEW YORK

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 10005

Employer Phone No. 646-616-8644

Employer Phone Extent No. -

Total Number of Employees 50

Employer Year of Commenced 2000

NAICS Code 541712

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Marianna Shlak

Employer Contact Address Line1 40 Wall Street

Employer Contact Address Line2 24th Floor

Employer Contact City New York

Employer Contact State/ Provice NEW YORK

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 10005

Employer Contact Phone 646-616-8644

Employer Contact Email marianna.shlak@tballiance.org

Attorney

11 fields

Agent/ Attorney Name Nicholas J Rudnick

Agent/ Attorney Firm Name Rudnick Immigration Group P.C.

Agent/ Attorney Phone (215) 964-6194

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 1845 Walnut Street

Agent/ Attorney Address Line 2 Suite 1550

Agent/ Attorney City Philadelphia

Agent/ Attorney State/ Province PENNSYLVANIA

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 19103

Agent/ Attorney Email nrudnick@rudnickgroup.com

Position Info

89 fields

Prevailing Wage Track Number P10021280630845

Prevailing Wage SOC Code 11-3051

Prevailing Wage SOC Title Quality Control Systems Managers

Prevailing Wage Skill Level Level II

Prevailing Wage 121118

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2022-04-05

Prevailing Wage Expiration Date 2022-07-04

Wage Offer From 125000

Wage Offer To 165000

Wage Offer Unit of Pay Year

Workstie Address Line 1 40 Wall Street

Worksite Address Line 2 24th Floor

Worksite City New York

Worksite State NEW YORK

Worksite Postal Code 10005

Job Title Chemistry, Manufacturing, & Controls (CMC) Project Manager

Minimum Education Bachelor's

Other Degree/ Diploma -

Major Field of Study Pharmacy, Chemistry, Chemical Engineering, or closely related field

Required Training N

Required Training Month -

Required Field of Training -

Required Experience Y

Required Expreience Months 24

Accept Alternate Field of Study N

Accept Alternate Major -

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 24

Accept Alternate Job Title Associate Director, Lead CMC Late Stage Product Development or contd in H.14

Normal Requirements of Job Opportunity Y

Required Foreign Language N

Specific Skills Background in education, training, or experience must include intimate knowledge of the analytical testing methods that ensure compliance with the cGMP requirements established by the FDA and other stringent regulatory authorities; complete familiarity with the CMC regulations established by the FDA, WHO, and EMA to ensure compliance; thorough understanding of cGMP regulations to ensure that quality standards are maintained for investigational medicinal products manufactured by the organization; good understanding of the import and export regulations for facilitating the manufacturing and distribution of clinical supplies; thorough understanding of preformulation development, analytical method development, specification setting, and planning stability studies; good understanding of clinical study design and execution. Up to 20 domestic and international travel for manufacturing site visits, scientific meetings, quality inspections, and due diligence visits; no telecommuting benefit, no alternate work or residence location available. Any suitable combination of education, training, and experience is acceptable.br br br contd from H.10B in similar positions in the pharmaceutical industry

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 2022-04-19

Job Oder End Date 2022-05-19

Sunday Edition Newspaper Y

First Newspaper Name The New York Times

First Advertisement Start Date 2022-04-24

Second Newspaper Name The New York Times

Second Advertisement Type Newspaper

Second Ad Start Date 2022-05-01

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date 2022-04-19

Employer Website to Date 2022-05-04

Pro. Org. Ad from Date -

Pro.Org. Ad to Date -

Job Search Website from Date 2022-04-23

Job Search Website to Date 2022-04-29

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 2022-04-25

Local Ethnic Newspaper to Date 2022-04-25

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 Bachelor's

Foreign Worker Education Other -

Foreign Worker Major CHEMISTRY

Year of Compelted Education 2007

Foreign Worker Istitution of Eduation ANDHRA UNIVERSITY

Foreign Worker Education Instution Address Line 1 WALTAIR JUNCTION

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City VISAKHAPATNAM

Foreign Worker Educatution Institution State ANDHRA PRADESH

Foreign Worker Education Institution Country INDIA

Foreign Worker Education Training Post Code 530003

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N

Foreign Worker Alternate Education and Experience N/A

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 Nicholas J Rudnick

Preparer Title Lawyer

Preparer Email nrudnick@rudnickgroup.com

Employer Information Declaration Name Marianna Shlak

Employer Declaration Title Director, Human Resources