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Director - Biologics & Vaccines. Job in West Point, Pennsylvania, United States in Merck & Co., Inc.. Nelest.com
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Director - Biologics & Vaccines

col-narrow-left   

Job ID:

22194

Location:

West Point, PA 

Job function:

Project Management, Research & Development
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director - Biologics & Vaccines

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.

Manage organization of exempt (10-15) employees and contractors responsible for managing the Vaccine and Biologics bio-stability and release activities, sample management, laboratory information management (LIMS) , Critical Reagent management and critical documents such as batch records, SOPs and Analytical Procedures (APs). Organization responsibilities include Compliance and Good Manufacturing Practices (GMP) including document control, sample and data management, facilities and equipment in support of bulk clinical supplies (RM, Seeds, banks, drug substance, and drug product) for vaccine and biologic candidates. Assure the department complies with all GMP issues including change management, risk management and investigational deviations. Provide support for internal and external inspection and audits. BPR&D representative for Site Quality Council, MRL Quality Council, Global Quality Council and Vaccine Specification Committee. Travel: No Description Director - Biologics & Vaccines-BIO004494 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.
Manage organization of exempt (10-15) employees and contractors responsible for managing the Vaccine and Biologics bio-stability and release activities, sample management, laboratory information management (LIMS) , Critical Reagent management and critical documents such as batch records, SOPs and Analytical Procedures (APs). Organization responsibilities include Compliance and Good Manufacturing Practices (GMP) including document control, sample and data management, facilities and equipment in support of bulk clinical supplies (RM, Seeds, banks, drug substance, and drug product) for vaccine and biologic candidates. Assure the department complies with all GMP issues including change management, risk management and investigational deviations. Provide support for internal and external inspection and audits. BPR&D representative for Site Quality Council, MRL Quality Council, Global Quality Council and Vaccine Specification Committee. Qualifications Education:
  • MS in Engineering or Life Sciences with a minimum of 10 years of related experience or a PhD (or advanced degree) in Engineering or Life Sciences with a minimum of 8 years of related experience.

Job Requirements:

Qualifications Education:
  • MS in Engineering or Life Sciences with a minimum of 10 years of related experience or a PhD (or advanced degree) in Engineering or Life Sciences with a minimum of 8 years of related experience.


Required:
  • Minimum of 5 years in a People Management role
  • Ability to manage and engage personnel, plan and assign work, evaluate performance, reward and discipline employees, address and resolve problems.
  • Provide guidance, mentor and motivate staff to achieve goals and objectives.
  • Laboratory Information System (LIMS) experience.
  • Experience establishing release specifications for vaccines.
  • Experience establishing criteria for stability studies.


Preferred:
  • Strong understanding of Quality Systems and Regulatory requirements for all aspects of GMP manufacturing.
  • Strong Collaboration skills and ability to work across organizations
  • Ability to manage multiple projects and timelines with both short and long term goals.




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:

19486

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

Director - Biologics & Vaccines

col-narrow-left   

Job ID:

22194

Location:

West Point, PA 

Job function:

Project Management, Research & Development
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director - Biologics & Vaccines

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.

Manage organization of exempt (10-15) employees and contractors responsible for managing the Vaccine and Biologics bio-stability and release activities, sample management, laboratory information management (LIMS) , Critical Reagent management and critical documents such as batch records, SOPs and Analytical Procedures (APs). Organization responsibilities include Compliance and Good Manufacturing Practices (GMP) including document control, sample and data management, facilities and equipment in support of bulk clinical supplies (RM, Seeds, banks, drug substance, and drug product) for vaccine and biologic candidates. Assure the department complies with all GMP issues including change management, risk management and investigational deviations. Provide support for internal and external inspection and audits. BPR&D representative for Site Quality Council, MRL Quality Council, Global Quality Council and Vaccine Specification Committee. Travel: No Description Director - Biologics & Vaccines-BIO004494 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.
Manage organization of exempt (10-15) employees and contractors responsible for managing the Vaccine and Biologics bio-stability and release activities, sample management, laboratory information management (LIMS) , Critical Reagent management and critical documents such as batch records, SOPs and Analytical Procedures (APs). Organization responsibilities include Compliance and Good Manufacturing Practices (GMP) including document control, sample and data management, facilities and equipment in support of bulk clinical supplies (RM, Seeds, banks, drug substance, and drug product) for vaccine and biologic candidates. Assure the department complies with all GMP issues including change management, risk management and investigational deviations. Provide support for internal and external inspection and audits. BPR&D representative for Site Quality Council, MRL Quality Council, Global Quality Council and Vaccine Specification Committee. Qualifications Education:
  • MS in Engineering or Life Sciences with a minimum of 10 years of related experience or a PhD (or advanced degree) in Engineering or Life Sciences with a minimum of 8 years of related experience.

Job Requirements:

Qualifications Education:
  • MS in Engineering or Life Sciences with a minimum of 10 years of related experience or a PhD (or advanced degree) in Engineering or Life Sciences with a minimum of 8 years of related experience.


Required:
  • Minimum of 5 years in a People Management role
  • Ability to manage and engage personnel, plan and assign work, evaluate performance, reward and discipline employees, address and resolve problems.
  • Provide guidance, mentor and motivate staff to achieve goals and objectives.
  • Laboratory Information System (LIMS) experience.
  • Experience establishing release specifications for vaccines.
  • Experience establishing criteria for stability studies.


Preferred:
  • Strong understanding of Quality Systems and Regulatory requirements for all aspects of GMP manufacturing.
  • Strong Collaboration skills and ability to work across organizations
  • Ability to manage multiple projects and timelines with both short and long term goals.




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:

19486
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