CMC Submission Lead

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About This H-1B Filing

This Labor Condition Application (LCA) was filed by Shire Human Genetic Therapies Inc. for the position of CMC Submission Lead in Lexington, Massachusetts. The offered annual salary is $97k, compared to the prevailing wage of $89k for this occupation and location. This represents a wage premium of +8.6% above the prevailing wage.

The LCA is the first step in the H-1B visa process. Employers must file an LCA with the Department of Labor certifying that they will pay the foreign worker at least the prevailing wage for the occupation in the area of intended employment. A certified LCA is required before the employer can file an H-1B petition with USCIS.

Case status: Certified. This means the Department of Labor has certified that the employer meets the wage and working condition requirements.

Understanding This LCA Filing

A Labor Condition Application (LCA) is a mandatory document that U.S. employers must file with the U.S. Department of Labor (DOL) before they can petition for a foreign worker under the H-1B, H-1B1, or E-3 visa categories. The LCA process was established under the Immigration and Nationality Act (INA) to protect both foreign and domestic workers by ensuring fair wages and working conditions.

Why Employers File LCAs

When a U.S. company identifies a foreign national to fill a specialty occupation position, they must first obtain DOL certification through the LCA process before filing the H-1B petition (Form I-129) with U.S. Citizenship and Immigration Services (USCIS). In this case, Shire Human Genetic Therapies Inc. filed LCA case number I-200-24143-025204 to sponsor a CMC Submission Lead position at their worksite in Lexington, Massachusetts. By filing this LCA, the employer attests to four key conditions: (1) paying the higher of the actual wage or prevailing wage, (2) providing working conditions that will not adversely affect other similarly employed workers, (3) no strike or lockout at the worksite, and (4) providing notice of the filing to the bargaining representative or posting notice at the worksite.

What Wage Levels Mean

The DOL establishes four wage levels for each occupation and geographic area, representing the progression from entry-level to fully competent workers:

• Level 1 (Entry) — Workers who have a basic understanding of the occupation and perform routine tasks under close supervision. Typically offered to recent graduates or those new to the role.
• Level 2 (Qualified) — Workers who have a good understanding of the occupation and can exercise independent judgment on moderately complex tasks.
• Level 3 (Experienced) — Workers who have a deep understanding and special skills, capable of handling unusual or complex problems with minimal supervision.
• Level 4 (Fully Competent) — Workers who are recognized experts in the field, exercising authority and independent judgment on the most complex aspects of the occupation.

For this filing, the offered wage of $97k compares to the DOL prevailing wage of $89k for Regulatory Affairs Specialists positions in the Lexington, Massachusetts area. The positive wage premium of +8.6% indicates the employer is offering above the DOL-determined average for this occupation and location.

What is Prevailing Wage?

The prevailing wage is the average wage paid to similarly employed workers in a specific occupation in the area of intended employment. The DOL determines prevailing wages using data from the Occupational Employment and Wage Statistics (OEWS) survey conducted by the Bureau of Labor Statistics (BLS). Employers must pay H-1B workers the higher of the prevailing wage or the actual wage paid to other employees in similar positions at the company. This requirement is designed to prevent employers from using H-1B workers to undercut domestic wages.

How to Interpret This Data

What Certified Means for This Application

A "Certified" status means the DOL has reviewed Shire Human Genetic Therapies Inc.'s attestations and determined that the LCA meets all regulatory requirements. The employer has demonstrated that the offered wage of $97k meets or exceeds the prevailing wage for CMC Submission Lead positions in the Lexington, Massachusetts area. It is important to understand that LCA certification does not guarantee H-1B visa approval. The next step is for the employer to file Form I-129 with USCIS, which evaluates whether the position qualifies as a specialty occupation and whether the beneficiary has the required qualifications.

Processing Time

This LCA was received by the DOL on May 22, 2024 and a decision was rendered on May 30, 2024, a processing time of approximately 8 business days. The standard DOL processing time for LCA applications is 7 to 10 business days. This application was processed within the standard timeframe.

Comparing to Industry Standards

The offered salary of $97k for this CMC Submission Lead position provides a data point for evaluating compensation trends in H-1B visa sponsorship. When reviewing H-1B salary data, consider that wages vary significantly based on geographic location, employer size, industry sector, and the worker's experience level. This position falls under SOC code 13-104107 (Regulatory Affairs Specialists), which standardizes how the Bureau of Labor Statistics classifies occupations across industries. Metropolitan areas like New York, San Francisco, and Seattle typically command higher salaries due to higher costs of living, while positions in smaller markets may offer lower nominal wages but comparable purchasing power.

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