Fiscal Year

2024

Case Number

A-23100-25278

Case Status

Certified

Received Date

2023-04-14

Decision Date

2024-05-14

Refile

N

Original File Date

2024-01-01 01:21:40

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

MIRATI THERAPEUTICS, INC.

Employer Name Slug

mirati-therapeutics-inc

Employer Address 1

3545 CRAY COURT

Employer Address 2

Employer City

SAN DIEGO

Employer City Slug

san-diego

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92121

Employer Phone

(619) 816-4090

Employer Number of Employees

184

Employer Year Commenced Business

2013

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Sarah Jager

Employer Contact Address 1

3545 Cray Court

Employer Contact Address 2

Employer Contact City

San Diego

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92121

Employer Contact Phone

(619) 816-4053

Employer Contact Email

jagers@mirati.com

Agent Attorney Name

Grace A Zimmerman

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

(858) 642-0420

Agent Attorney Address 1

P.O. Box 919016

Agent Attorney Address 2

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92191-9016

Agent Attorney Email

Grace@larrabee.com

PW Track Number

P10022195350889

PW SOC Code

19-2031.00

PW SOC Title

Chemists

PW Skill Level

Level IV

PW Wage

97698.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2023-01-24

PW Expiration Date

2023-06-30

Wage Offer From

139589.00

Wage Offer To

0.00

Average Salary

139589.00

Wage Unit of Pay

Year

Worksite Address 1

3545 Cray Court

Worksite Address 2

Worksite City

San Diego

Worksite City Slug

san-diego

Worksite State

CALIFORNIA

Worksite Postal Code

92121

Job Title

Formulation Scientist, Product Development

Job Title Slug

formulation-scientist-product-development

Minimum Education

Master's

Major Field of Study

Pharmaceutical Sciences or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.4B.

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

60

Accept Alternative Job Title

process development see H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.10B. experience in oral solid dosage formulation and process development to include any relevant job titles in these occupations; experience must be in the pharmaceutical industry.br br In H.12, job requirements are normal for the employer due to the complexity of job duties associated with this position and common in the industry. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. Developing conventional and enabling solid oral dose formulations and related manufacturing unit operations, including Dry Granulation, Wet Granulation, Milling, Blending, Compression, and Film Coating. 2. Design of Experiment DoE, execution, characterization, and data analysis during formulation screening stage. 3. Applying cGMP requirements for drug product development and manufacturing. 4. Working with crossfunctional groups, including preformulation, earlystage product development, analytical development, clinical, quality and regulatory, to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate procedures GLP, GMP, and ICH. 5. Supporting drug product manufacturing at CDMOs for phases 1, 2 and 3 of clinical studies. 6. Conducting and coordinating conventional and enabling formulation feasibility screening and assessments, technology selection and product development activities internally and externally. 7. Performing research studies to support preformulation, formulation, and process development of oral solid dosage forms. 8. Designing and optimizing prototype formulations, conducting inhouse experiments, and transferring technology to CDMOs for manufacturing CTMs. 9. Performing material characterization flow, compressibility, and particle size distribution of lab and pilot scale manufacturing process of pharmaceutical unit operations. 10. Performing FMEA and risk assessment during formulation and process development. 11. Authoring technical documents for formulation and process development and contribute to preparation of CMC sections for regulatory filings IND, NDA, and MAA. 12. Working with cross functional groups Analytical, Quality, and Regulatory to ensure all drug product requirements are met. 13. Generating drug formulation data and documentation, including data summaries, technical reports, scientific presentations, and regulatory documents. Position requires 15 domestic and 5 international travel; expenses paid by employer.

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

2022-11-23

SWA Job Order End Date

2022-12-23

Sunday Edition Newspaper

Y

First Newspaper Name

San Diego Union Tribune

First Advertisement Start Date

2022-12-11

Second Newspaper Ad Name

San Diego Union Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-12-18

Employer Website From Date

2022-12-06

Employer Website To Date

2022-12-13

Professional Organization Ad From Date

2024-01-01 01:21:40

Professional Organization Advertisement To Date

2024-01-01 01:21:40

Job Search Website From Date

2022-12-12

Job Search Website To Date

2022-12-19

Employee Referral Program From Date

2024-01-01 01:21:40

Employee Referral Program To Date

2024-01-01 01:21:40

Local Ethnic Paper From Date

2024-01-01 01:21:40

Local Ethnic Paper To Date

2024-01-01 01:21:40

Radio/TV Ad From Date

2024-01-01 01:21:40

Radio/TV Ad To Date

2024-01-01 01:21:40

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 SCIENCES

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

CAMPBELL UNIVERSITY

Foreign Worker Education Institution Address 1

143 MAIN STREET

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BUIES CREEK

Foreign Worker Education Institution State/Province

NC

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

27506

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Grace A Zimmerman

Preparer Title

Partner Attorney at Law

Preparer Email

grace@larrabee.com

Employer Information Declaration Name

Michael E Paolucci

Employer Information Declaration Title

EVP, Chief People Officer