Associate Principal Scientist Job
- Employer
- Merck
- Location
- West Point PA
- Closing date
- Oct 17, 2016
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Job Details
Associate Principal Scientist-PRO014174
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.
Biologics Process Development and Commercialization is responsible for the commercialization of biological processes from Phase III through launch and transfer to commercial supply network. Activities include process development, scale-up and optimization, interfacing with a network of facilities for product manufacturing and subsequent validation and filing documentation, and transfer to supply network. BPDC is part of the Merck Manufacturing Division.
Under the general scientific and administrative direction of the Director of BPDC and working in conjunction with internal and external partners, this individual will support late stage bulk process development, characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to therapeutic proteins. The individual will demonstrate scientific, experimental and tech transfer skills focusing on cell culture processing.
Responsibilities:
- Responsible for development and characterization of late stage protein purification processes suitable for PPQ, licensure, and commercial manufacturing.
- Able to work independently and lead multidisciplinary teams.
- Responsible for managing outsourced process development and characterization activities at CMO/ TPO.
- Responsible for development, execution, and documentation of process characterization studies of downstream processes using advanced skills in QbD, DOE, PAT, and data analysis.
- Responsible for development of optimized post-launch process.
- Responsible for tech transfer of downstream processes for production of therapeutic proteins including drafting of technical reports and manufacturing documentation. Interfaces with early development, technical operations, and manufacturing departments to facilitate transfer of manufacturing processes.
- Responsible for downstream related CMC enabling documentation.
- Project management and participation in cross-functional/global CMC teams.
- Manages and is responsible for the quality level of downstream related process development studies and documentation.
- Participates, as the protein purification subject matter expert, in regulatory inspections and is experienced with the cGMP and regulatory guidelines.
- Identifies new technologies and works to implement new platforms with cross-functional early and late stage development teams.
Qualifications
Education Requirement:
- PhD/MS/BS in biological sciences, biochemistry, biochemical engineering, or related field.
Required Experience:
- PhD with minimum of 3 years industry experience, or MS with minimum of 5 years industry experience, or BS with minimum of 8 years industry experience.
- Relevant experience with monoclonal antibody / vaccine downstream process development.
Preferred Experience:
- Proven strong scientific, project, and people management skills.
- Strong communicator and ability to build bridges between groups and organizations.
- Excellent analytical and technical skills.
- Demonstrated initiative, and innovative process-oriented thinking within a team environment.
- Experience with technology transfer across sites and/or geographies.
- Experience with supporting regulatory filings for US and worldwide markets.
- Knowledge of regulatory and quality guidelines.
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 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.
Job: Process Engineering
Job Title:Assoc Prin. Scientist, Engineering
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 5
Shift (if applicable): 1st
Company Trade Name:Merck
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.
Biologics Process Development and Commercialization is responsible for the commercialization of biological processes from Phase III through launch and transfer to commercial supply network. Activities include process development, scale-up and optimization, interfacing with a network of facilities for product manufacturing and subsequent validation and filing documentation, and transfer to supply network. BPDC is part of the Merck Manufacturing Division.
Under the general scientific and administrative direction of the Director of BPDC and working in conjunction with internal and external partners, this individual will support late stage bulk process development, characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to therapeutic proteins. The individual will demonstrate scientific, experimental and tech transfer skills focusing on cell culture processing.
Responsibilities:
- Responsible for development and characterization of late stage protein purification processes suitable for PPQ, licensure, and commercial manufacturing.
- Able to work independently and lead multidisciplinary teams.
- Responsible for managing outsourced process development and characterization activities at CMO/ TPO.
- Responsible for development, execution, and documentation of process characterization studies of downstream processes using advanced skills in QbD, DOE, PAT, and data analysis.
- Responsible for development of optimized post-launch process.
- Responsible for tech transfer of downstream processes for production of therapeutic proteins including drafting of technical reports and manufacturing documentation. Interfaces with early development, technical operations, and manufacturing departments to facilitate transfer of manufacturing processes.
- Responsible for downstream related CMC enabling documentation.
- Project management and participation in cross-functional/global CMC teams.
- Manages and is responsible for the quality level of downstream related process development studies and documentation.
- Participates, as the protein purification subject matter expert, in regulatory inspections and is experienced with the cGMP and regulatory guidelines.
- Identifies new technologies and works to implement new platforms with cross-functional early and late stage development teams.
Qualifications
Education Requirement:
- PhD/MS/BS in biological sciences, biochemistry, biochemical engineering, or related field.
Required Experience:
- PhD with minimum of 3 years industry experience, or MS with minimum of 5 years industry experience, or BS with minimum of 8 years industry experience.
- Relevant experience with monoclonal antibody / vaccine downstream process development.
Preferred Experience:
- Proven strong scientific, project, and people management skills.
- Strong communicator and ability to build bridges between groups and organizations.
- Excellent analytical and technical skills.
- Demonstrated initiative, and innovative process-oriented thinking within a team environment.
- Experience with technology transfer across sites and/or geographies.
- Experience with supporting regulatory filings for US and worldwide markets.
- Knowledge of regulatory and quality guidelines.
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 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.
Job: Process Engineering
Job Title:Assoc Prin. Scientist, Engineering
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 5
Shift (if applicable): 1st
Company Trade Name:Merck
Company
Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.
We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work
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