Accept Alternate Major:Biochemistry, Pharmaceutical Manufacturing, or a directly related field
Alternate Combination of Education/ Experience:Y
Required Alternate Level of Education :Bachelor's
Other Alternate Level of Education:
Acceptable Years of Experience:8
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:60
Accept Alternate Job Title:Experience in clinical trials phase 1 through phase 3 or commercial drug production
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Experience may be gained concurrently and must include five 5 years in each of the followingbr Applying expertise in product lifecycle, process validation, analytical methods, tech transfers, shipping validation, and related functionsbr Applying technical understanding of biopharmaceutical productionbr Applying current good manufacturing practice CGMP guidelines, ICH, FDA, and EMA regulatory requirements relevant to process development, scaleup, and validationbr MS Projectbr Applying risk assessment tools including Failure Modes and Effects Analysis FMEA and Process Hazard Analysis PHAbr Project management experience including ability to make independent sound decisions and manage priorities in alignment with department objectivesbr Supporting internal regulatory and partner inspectionsbr Collaborating with internal counterparts or contract manufacturersbr Leading cross functional teamsbr Capability to effectively manage 1 or more individual contributors.br br Experience may be gained before, during, or after issuance of advanced degree.
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:2021-09-13
Job Oder End Date:2021-10-18
Sunday Edition Newspaper:Y
First Newspaper Name:The Boston Globe
First Advertisement Start Date:2021-09-26
Second Newspaper Name:The Boston Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-10-03
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-09-22
Job Search Website to Date:2021-10-06
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2021-09-21
Employee Referral Program to Date:2021-10-18
Campus Placement from Date:2021-09-15
Campus Placement to Date:2021-09-27
Local Ethnic Newspaper from Date:
Local Ethnic Newspaper to Date:
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
Foreign Worker Education:Master's
Foreign Worker Education Other:
Foreign Worker Major:PHARMACEUTICAL MANUFACTURING
Year of Compelted Education:2011
Foreign Worker Istitution of Eduation:STEVENS INSTITUTE OF TECHNOLOGY
Foreign Worker Education Instution Address Line 1:1 CASTLE POINT TERRACE
Foreign Worker Education Institution Address Line 2:
Foreign Worker Education Institution City:HOBOKEN
Foreign Worker Educatution Institution State:NJ
Foreign Worker Education Institution Country :UNITED STATES OF AMERICA
Foreign Worker Education Training Post Code:7030
Foreign Worker Training Completion :N/A
Foreign Worker Required Experience :N/A
Foreign Worker Alternate Education and Experience :N
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:IRMA I DIAS
Preparer Title:Attorney
Preparer Email :packardteam@fragomen.com
Employer Information Declaration Name:JOSH STOFFEL
