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Vaccines Bioanalytical Compliance Lead. Job in Kenilworth, New Jersey, United States in Merck & Co., Inc.. Nelest.com
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Vaccines Bioanalytical Compliance Lead

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Job ID:

22109

Location:

Kenilworth, NJ 

Job function:

Legal Services
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Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Vaccines Bioanalytical Compliance Lead

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

This position will provide quality & compliance oversight of regulated bioanalysis as a part of the biologics and vaccines bioanalytics compliance team at Merck. Primarily, the successful candidate will serve as a lead quality representative covering external vaccines clinical testing labs, and will provide quality guidance as well as data/report reviews during method qualification/validation and clinical sample analysis.

This will include leading periodic site visits at external labs for on-site review of data and laboratory processes. The role will also provide quality oversight of internal laboratories, and will partner with scientific staff and Quality Assurance (QA) for data reviews, process improvements, and to support internal and external audits. Experience with multiple vaccines assays and platforms (e.g. PRNT, MOPA, ELISA, MSD, PCR, etc.) is required, and applicants should have a strong scientific and quality background with experience working with external contract research labs.

This may include candidates with previous lab and quality roles, or those with regulated lab experience looking to transition into a quality role. Some degree of travel between PA and NJ sites will be required to support internal labs, with ~10-20% travel to external laboratories. Travel: Yes, 20 % of the Time Description Vaccines Bioanalytical Compliance Lead-REG002208 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This position will provide quality & compliance oversight of regulated bioanalysis as a part of the biologics and vaccines bioanalytics compliance team at Merck. Primarily, the successful candidate will serve as a lead quality representative covering external vaccines clinical testing labs, and will provide quality guidance as well as data/report reviews during method qualification/validation and clinical sample analysis.
This will include leading periodic site visits at external labs for on-site review of data and laboratory processes. The role will also provide quality oversight of internal laboratories, and will partner with scientific staff and Quality Assurance (QA) for data reviews, process improvements, and to support internal and external audits. Experience with multiple vaccines assays and platforms (e.g. PRNT, MOPA, ELISA, MSD, PCR, etc.) is required, and applicants should have a strong scientific and quality background with experience working with external contract research labs.
This may include candidates with previous lab and quality roles, or those with regulated lab experience looking to transition into a quality role. Some degree of travel between PA and NJ sites will be required to support internal labs, with ~10-20% travel to external laboratories. Qualifications Education:
  • BA/BS in the sciences with a minimum of 7 years' experience or a MS in the sciences with a minimum of 4 years' experience.

Job Requirements:

Qualifications Education:
  • BA/BS in the sciences with a minimum of 7 years' experience or a MS in the sciences with a minimum of 4 years' experience.
Required:
  • Experience with multiple vaccines clinical assays and platforms, including at least a few of the following: PRNT, MOPA, ELISPOT, PCR, ELISA, ICS, and MSD.
  • Laboratory or quality based experience in regulated bioanalytical labs under GLPs, GCLPs, local SOPs, and/or regulatory guidances.
  • Experience providing review of assay data and reports, including review of laboratory notebooks, qualification/validation plans, and qualification/validation reports.

Preferred:
  • Experience working with external contract research labs that provide vaccine clinical assay development, qualification, validation, and sample analysis.
  • Experience with oversight of biologics bioanalytical assays in a GLP environment.


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

7033

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Vaccines Bioanalytical Compliance Lead

col-narrow-left   

Job ID:

22109

Location:

Kenilworth, NJ 

Job function:

Legal Services
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Vaccines Bioanalytical Compliance Lead

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

This position will provide quality & compliance oversight of regulated bioanalysis as a part of the biologics and vaccines bioanalytics compliance team at Merck. Primarily, the successful candidate will serve as a lead quality representative covering external vaccines clinical testing labs, and will provide quality guidance as well as data/report reviews during method qualification/validation and clinical sample analysis.

This will include leading periodic site visits at external labs for on-site review of data and laboratory processes. The role will also provide quality oversight of internal laboratories, and will partner with scientific staff and Quality Assurance (QA) for data reviews, process improvements, and to support internal and external audits. Experience with multiple vaccines assays and platforms (e.g. PRNT, MOPA, ELISA, MSD, PCR, etc.) is required, and applicants should have a strong scientific and quality background with experience working with external contract research labs.

This may include candidates with previous lab and quality roles, or those with regulated lab experience looking to transition into a quality role. Some degree of travel between PA and NJ sites will be required to support internal labs, with ~10-20% travel to external laboratories. Travel: Yes, 20 % of the Time Description Vaccines Bioanalytical Compliance Lead-REG002208 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This position will provide quality & compliance oversight of regulated bioanalysis as a part of the biologics and vaccines bioanalytics compliance team at Merck. Primarily, the successful candidate will serve as a lead quality representative covering external vaccines clinical testing labs, and will provide quality guidance as well as data/report reviews during method qualification/validation and clinical sample analysis.
This will include leading periodic site visits at external labs for on-site review of data and laboratory processes. The role will also provide quality oversight of internal laboratories, and will partner with scientific staff and Quality Assurance (QA) for data reviews, process improvements, and to support internal and external audits. Experience with multiple vaccines assays and platforms (e.g. PRNT, MOPA, ELISA, MSD, PCR, etc.) is required, and applicants should have a strong scientific and quality background with experience working with external contract research labs.
This may include candidates with previous lab and quality roles, or those with regulated lab experience looking to transition into a quality role. Some degree of travel between PA and NJ sites will be required to support internal labs, with ~10-20% travel to external laboratories. Qualifications Education:
  • BA/BS in the sciences with a minimum of 7 years' experience or a MS in the sciences with a minimum of 4 years' experience.

Job Requirements:

Qualifications Education:
  • BA/BS in the sciences with a minimum of 7 years' experience or a MS in the sciences with a minimum of 4 years' experience.
Required:
  • Experience with multiple vaccines clinical assays and platforms, including at least a few of the following: PRNT, MOPA, ELISPOT, PCR, ELISA, ICS, and MSD.
  • Laboratory or quality based experience in regulated bioanalytical labs under GLPs, GCLPs, local SOPs, and/or regulatory guidances.
  • Experience providing review of assay data and reports, including review of laboratory notebooks, qualification/validation plans, and qualification/validation reports.

Preferred:
  • Experience working with external contract research labs that provide vaccine clinical assay development, qualification, validation, and sample analysis.
  • Experience with oversight of biologics bioanalytical assays in a GLP environment.


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

7033
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