GMP Specialist 8/26/2016

Biotechnology Gaithersburg, MD

Company
Biotechnology
Job Classification
Full Time
Company Ref #
29314284
AJE Ref #
575988818
Location
Gaithersburg, MD
Job Type
Regular

JOB DESCRIPTION

APPLY
POSITION TITLE: GMP SPECIALIST

LOCATION: GAITHERSBURG, MD AREA

RELOCATION: POSSIBLE

POSITION TYPE: STAFF POSITION WITH GREAT BENEFITS

SALARY: $60K - $64K, D.O.E. + BONUS POTENTIAL

POSITION NUMBER: 9119

SUMMARY:

Our client is an international company providing contract manufacturing and research services in the fields of immunology, vaccines, and biotherapeutics, from cell line and process development, to GMP manufacturing, QC release testing and regulatory support. They have asked Hallmark to help them find a GMP Specialist to augment their staff. The person in this role will help to manufacture various scale products in accordance with current Good Manufacturing Practices. This is a staff position with great benefits and excellent career potential.

RESPONSIBILITIES:

* Perform purification of proteins using various column chromatography.
* Perform column packing and qualifications of various resins.
* Operate and maintain production equipment, such as AKTA Purifier, AKTA Pilot, and AKTA Process according to the SOPs in place.
* 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.
* Perform integrity testing on various types of filters.
* Write batch records and SOPs for the downstream operations.
* Review documentation and calculations (e.g. tickets, labels, equipment reading).
* Purchase raw material / production items as needed.
* Comply with safety regulations, cGMP, SOP and manufacturing documentation requirements.
* Interact with other departments involved in GMP manufacturing for planning production, testing and timely product release.
* Participate in technology transfer of processes from Process Development to Manufacturing.
* Cross functional work with the upstream manufacturing group to provide resources as needed.
* Perform tasks under minimal supervision, and within tight timelines to meet production schedules.
* Occasional overtime and weekend work is required.

EXPERIENCE AND SKILLS:

* Bachelor's or Master's Degree in Biochemistry, Chemistry, Chemical Engineering or Biology.
* 3+ years of experience in the bio-manufacturing industry.
* Experience with Downstream cGMP Manufacturing is required.
* Experience using Unicorn software is required.
* Skill with MS Office suite (Word, Excel, PowerPoint).
* Excellent interpersonal skills, as well as verbal and written communication skills.
* Must be analytical, organized, detail-oriented, and self-motivated, with the ability to multi-task.
* Must be able to pass pre-employment physical and drug screen.

OTHER:

Hallmark and our Client are Affirmative Action, Equal Opportunity Employers. We encourage all qualified people with the current right to work for any employer in the USA to apply. NOTE: We cannot consider H-1 Visa candidates for this position. Principals only, please.