Associate Principal Scientist, Engineering Job
- Employer
- Merck
- Location
- West Point PA
- Closing date
- Oct 17, 2016
View more
- Sector
- Science, Computer Science and IT, Information Science and Technology, Life Sciences, Cell and Molecular Biology, Microbiology/Virology, Physical Sciences and Engineering, Biomedical Engineering, Chemical Engineering, Chemistry, Biochemistry, Doctors, Infectious Disease, Veterinary Medicine
- Organization Type
- Corporate
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Job Details
Associate Principal Scientist, Engineering-PRO014204
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 (BPDC) organization within Merck Manufacturing Division (MMD) is responsible for the commercialization of biological processes (novel therapeutic proteins) and some secondary metabolite processes from Phase III through launch and transfer to supply. Activities include late stage process development, in-line support of therapeutic protein products, scale-up and optimization, interfacing with a network of facilities for product manufacturing and subsequent optimization, validation and filing documentation, and transfer to supply network. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the development and commercialization activities supporting multiple therapeutic protein programs.
Responsibilities:
- Development, execution and documentation of upstream microbial and/or mammalian cell culture and related studies supporting pipeline commercialization, life cycle management of the existing product portfolio, and support deviation investigations.
- Execution of activities supporting technical transfer of upstream processes from clinical to manufacturing sites or between manufacturing sites including process development and scale-up activities, technical documentation, process characterization, facility/equipment fit assessments, Process Performance Qualification (PPQ) and validation support.
- Evaluation and development of innovative process technologies and continuous process improvements to support in-line products.
- Partnering with commercial manufacturing teams to provide upstream subject matter expertise to support ongoing manufacturing activities.
- Under the general direction of the upstream team lead and working in conjunction with internal and external partners, this individual will support late stage bulk process development, scale-down model development, process characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to biologics products.
Qualifications
Education:
- B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 7 years of relevant experience; or Master's degree with 5 years of relevant experience; or Ph.D. with 3 years of relevant experience.
Required Experience:
- Do you have a minimum of three years industry experience in upstream process development and scaling (up and down) along with tech transfer of mammalian cell culture and/or microbial fermentation processes.
- Three (3) years commercialization experience in biologics, vaccine or other therapeutic proteins
- Deep technical knowledge and in-depth experience with upstream process development.
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
- Outstanding communication and people skills.
- cGMP experience will be a solid plus
- Ability to drive studies and experiments in the context of long-term commercialization plan.
- Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles.
- Solid experience in using software and statistical tools for data mining, data analysis and modeling is key.
- Advanced computer skills using MS Office Suite (Outlook, Word, Excel, Power Point etc.),
- Experience supporting/writing regulatory filings (IND, BLA) and inspections with multiple agencies (FDA, EMA, JNDA,).
- Experience with project strategic planning.
Preferred Experience:
- Upstream process development or downstream expertise with multiple programs and unit operations.
- Knowledgeable in Drug Substance, end to end process development.
- Strong cross functional background, enabling teams to reach peak performance.
Ability to provide scientific mentorship and guidance to technical coworkers and colleagues within and outside of Merck
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:Associate Principal Scientist, Engineering
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 3
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 (BPDC) organization within Merck Manufacturing Division (MMD) is responsible for the commercialization of biological processes (novel therapeutic proteins) and some secondary metabolite processes from Phase III through launch and transfer to supply. Activities include late stage process development, in-line support of therapeutic protein products, scale-up and optimization, interfacing with a network of facilities for product manufacturing and subsequent optimization, validation and filing documentation, and transfer to supply network. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the development and commercialization activities supporting multiple therapeutic protein programs.
Responsibilities:
- Development, execution and documentation of upstream microbial and/or mammalian cell culture and related studies supporting pipeline commercialization, life cycle management of the existing product portfolio, and support deviation investigations.
- Execution of activities supporting technical transfer of upstream processes from clinical to manufacturing sites or between manufacturing sites including process development and scale-up activities, technical documentation, process characterization, facility/equipment fit assessments, Process Performance Qualification (PPQ) and validation support.
- Evaluation and development of innovative process technologies and continuous process improvements to support in-line products.
- Partnering with commercial manufacturing teams to provide upstream subject matter expertise to support ongoing manufacturing activities.
- Under the general direction of the upstream team lead and working in conjunction with internal and external partners, this individual will support late stage bulk process development, scale-down model development, process characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to biologics products.
Qualifications
Education:
- B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 7 years of relevant experience; or Master's degree with 5 years of relevant experience; or Ph.D. with 3 years of relevant experience.
Required Experience:
- Do you have a minimum of three years industry experience in upstream process development and scaling (up and down) along with tech transfer of mammalian cell culture and/or microbial fermentation processes.
- Three (3) years commercialization experience in biologics, vaccine or other therapeutic proteins
- Deep technical knowledge and in-depth experience with upstream process development.
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
- Outstanding communication and people skills.
- cGMP experience will be a solid plus
- Ability to drive studies and experiments in the context of long-term commercialization plan.
- Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles.
- Solid experience in using software and statistical tools for data mining, data analysis and modeling is key.
- Advanced computer skills using MS Office Suite (Outlook, Word, Excel, Power Point etc.),
- Experience supporting/writing regulatory filings (IND, BLA) and inspections with multiple agencies (FDA, EMA, JNDA,).
- Experience with project strategic planning.
Preferred Experience:
- Upstream process development or downstream expertise with multiple programs and unit operations.
- Knowledgeable in Drug Substance, end to end process development.
- Strong cross functional background, enabling teams to reach peak performance.
Ability to provide scientific mentorship and guidance to technical coworkers and colleagues within and outside of Merck
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:Associate Principal Scientist, Engineering
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 3
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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