Sr. GMP Specialist – Downstream

Employer
ABL, Inc.
Location
Rockville, Maryland
Posted
Nov 02, 2018
Required Education
Bachelors Degree
Position Type
Full time

The role of the Sr. GMP Specialist – Downstream is to manufacture various scale products in accordance to the current Good Manufacturing Practices (cGMP).

MAIN ACCOUNTABILITIES:

The main responsibilities will include but are not limited to:

  • Perform purification of proteins using various column chromatography methods with minimal to no supervision.
  • Perform column packing and qualifications of various resins.
  • Clear understanding of the Unicorn software used for Akta purification skid operation.
  • Must be able to clearly understand and execute the methods programmed for column chromatography.
  • Perform UF/DF, and various filtration methods.
  • Assemble and operate Millistak Pod holders, and Millipore Cassettes holders.
  • Perform Aseptic technique in Biological Safety cabinets and Laminar Air Flow.
  • Write batch records and SOPs for the downstream operations.
  • Review executed documentation and check all calculations (e.g. tickets, labels, equipment reading).
  • Purchase raw material/ production items as needed.
  • Comply with safety requirements, cGMP, SOP and manufacturing documentation.
  • Occasional overtime and weekend work is required.
  • Interacts with other departments involved in GMP manufacturing to coordinate sample submission and receipt.
  • Participate in technology transfer of processes from Process Development to Manufacturing.
  • Work cross functional with the upstream manufacturing group to provide resources as needed.
  • Report any unexpected observations and suggest possible explanation and resolution.

KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:

  • Bachelor’s or Master’s Degree in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, Biology), with minimum 4-5 years of experience in the GMP biomanufacturing industry.
  • Minimum of 2 year specific Downstream cGMP Manufacturing experience is required.
  • Experience with operating the Unicron software is required.
  • Experience with writing/programming of Unicorn Methods is preferred.
  • Intermediate computer skills using MS Office (Word, Excel, Power Point) preferred.
  • Possess excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management and staff.
  • Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task.
  • Demonstrated ability to work as a strong contributor in a team environment and able to interaction with all echelons of management and staff.
  • Must be detail-oriented, dependable, motivated, ability to work with minimal supervision; Proven multi-tasker able to handle multiple projects well;
  • Strong/effective interpersonal skills, both communication and written & able to communicate effectively with all echelons of Management and staff.