Sr. Scientist, Biologics Pilot Plant Upstream/Downstream Operations Job
- Employer
- Merck
- Location
- West Point PA
- Closing date
- Oct 5, 2017
View more
- Sector
- Science, Computer Science and IT, Life Sciences, Cell and Molecular Biology, Physical Sciences and Engineering, Chemical Engineering, Chemistry, Law
- Organization Type
- Corporate
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Job Details
Sr. Scientist, Biologics Pilot Plant Upstream/Downstream Operations-BIO004943
Description
Applications sought for a Sr Scientist position within MRL’s Biologics Pilot Plant (BPP) Operations Team. Individual will support pilot-scale campaigns for the GMP manufacture of bulk biologic clinical supplies (vaccines and therapeutic proteins), providing oversight of either upstream or downstream operations (depending on skill set), with participation in the opposite discipline as needed. Responsibilities encompass all aspects of preparation, execution, and close out of a GMP campaign.
Candidate will participate in a range of activities including, but not limited to:
- Downstream operations such as tangential flow filtration, dead-end filtration, homogenization, lyophilization, chromatography, and centrifugation
- Upstream operations such as cell culture, virus production, and/or microbial fermentation
- Campaign document preparation (e.g. SOPs, batch records)
- Hands-on support during the manufacture of GMP batches, also supporting such activities as cleaning & steam-in-place
- Evaluating and integrating new technology / process equipment fit
- Supporting development of equipment specification & participating in start-up activities
- Supporting training, GMP, and safety initiatives
- Actively working in a multi-discipline project team environment
- Leading the troubleshooting on various process unit operations
Expectations are that the person will eventually lead projects/programs and be able to independently resolve problems and issues.
A good understanding of the regulatory guidelines governing GMP manufacture is important. Candidate is expected to work in a team atmosphere in close collaboration with development groups, facility engineering, quality engineering, GMP compliance, and safety groups. Some overtime (including weekends) and occasional second and third shift work will be required.
Qualifications
Education:
- A Bachelor’s Degree in Chemical Engineering or Biological Sciences with a minimum of seven (7) years of relevant experience, OR a Master’s degree with a minimum of four (4) years of relevant experience.
Required:
- Previous experience supporting processing of biologicals, or vaccines, and/or process development activities
- Previous experience and knowledge of downstream unit operations
- Previous experience and extensive knowledge of cGMPs
(US/Puerto Rico Only) In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. If you have any questions, please contact your HRBP or Staffing Consultant.
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Biological Manuf-Pilot Plant
Job Title:Sr. Scientist, Biologics Pre Manf
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 2
Hazardous Materials: Depends on program being supported;enter core sterile manufacturing areas
Company Trade Name:Merck
Description
Applications sought for a Sr Scientist position within MRL’s Biologics Pilot Plant (BPP) Operations Team. Individual will support pilot-scale campaigns for the GMP manufacture of bulk biologic clinical supplies (vaccines and therapeutic proteins), providing oversight of either upstream or downstream operations (depending on skill set), with participation in the opposite discipline as needed. Responsibilities encompass all aspects of preparation, execution, and close out of a GMP campaign.
Candidate will participate in a range of activities including, but not limited to:
- Downstream operations such as tangential flow filtration, dead-end filtration, homogenization, lyophilization, chromatography, and centrifugation
- Upstream operations such as cell culture, virus production, and/or microbial fermentation
- Campaign document preparation (e.g. SOPs, batch records)
- Hands-on support during the manufacture of GMP batches, also supporting such activities as cleaning & steam-in-place
- Evaluating and integrating new technology / process equipment fit
- Supporting development of equipment specification & participating in start-up activities
- Supporting training, GMP, and safety initiatives
- Actively working in a multi-discipline project team environment
- Leading the troubleshooting on various process unit operations
Expectations are that the person will eventually lead projects/programs and be able to independently resolve problems and issues.
A good understanding of the regulatory guidelines governing GMP manufacture is important. Candidate is expected to work in a team atmosphere in close collaboration with development groups, facility engineering, quality engineering, GMP compliance, and safety groups. Some overtime (including weekends) and occasional second and third shift work will be required.
Qualifications
Education:
- A Bachelor’s Degree in Chemical Engineering or Biological Sciences with a minimum of seven (7) years of relevant experience, OR a Master’s degree with a minimum of four (4) years of relevant experience.
Required:
- Previous experience supporting processing of biologicals, or vaccines, and/or process development activities
- Previous experience and knowledge of downstream unit operations
- Previous experience and extensive knowledge of cGMPs
(US/Puerto Rico Only) In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. If you have any questions, please contact your HRBP or Staffing Consultant.
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Biological Manuf-Pilot Plant
Job Title:Sr. Scientist, Biologics Pre Manf
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 2
Hazardous Materials: Depends on program being supported;enter core sterile manufacturing areas
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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