Scientist, Biologics Pilot Plant Upstream/Downstream Operations Job

Employer
Merck
Location
West Point, PA, US
Posted
September 12 2017
Discipline
Other
Organization Type
Pharma
Scientist, Biologics Pilot Plant Upstream/Downstream Operations-BIO004938

Description

Applications sought for a 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 or Mechanical Engineering or Biological Sciences with a minimum of three (3) years of relevant experience OR a Master’s Degree.

Required:

- Previous experience supporting processing of biologicals, or vaccines, and/or process development activities

- Previous experience and knowledge of downstream and/or upstream 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: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

Company Trade Name:Merck