Company: Icon Government and Public Health Solutions
Location: Silver Spring
Posted on: November 12, 2019
ICON Government and Public Health specializes in preclinical
through phase IV support of clinical research and clinical trial
services for biologics, drugs, and devices. We help our customers
get their products to market faster with a wide array of research,
regulatory, and sponsor services both within the US and around the
globe and respond rapidly to global health crises.
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to
perform, with or without reasonable accommodation, each essential
function satisfactorily. Reasonable accommodations may be made to
help enable qualified individuals with disabilities to perform the
* Supports successful implementation of new products and processes
into the facility.
* Assist with technology transfer from Process Development to
* Plan, order and account for consumption of raw materials and
* Prepare (wipe down) equipment and supplies for use in cleanroom
* Prepare and maintain reports and other documentation as
applicable to the scope of operations in the manufacturing
facility. Prepare and revise batch records and SOPs, as well as
drafting of technical reports.
* Coordinate sample testing and room release with QC.
* Assist in the installation, maintenance, cleaning and operation
of bioprocess equipment including chromatography systems, TFF
systems, centrifuges, analytical equipment and clean-in-place
* Ensures that standard operating procedures (SOPs) and batch
records are accurate, and followed in accordance with cGMP
* Conducts purification operations with an excellent understanding
and knowledge of isolating and purifying proteins antibodies, etc.
from microbial and cell culture processes.
* Extensive experience with processes including cell disruption,
operation and maintenance of tangential flow filtration devices,
column packing and chromatography (HIC, IEX, Affinity), UF/DF
operations, and aseptic filtration, sampling for QC testing and
storage of manufactured products. May be required to work evenings
* Operate bioprocess equipment under strict adherence to cGMP, OSHA
and required policies and regulations.
* Recognizes and escalates bioprocess operational risks to team
lead or Manager prior to failure, to ensure safety and compliance
* Recommends and executes projects and changes to bioprocess
operations to reduce risk and increase efficiency.
* Performs in-process assays to monitor process performance.
* Responsible basic trouble-shooting of technical issues and other
problems encountered within the manufacturing process. Write
deviation incident reports as needed.
* Carry out the manufacturing review (as delegated) of the
completed batch record logbooks in a timely manner per established
* Collaborate with the Quality Assurance group to fulfill quality
management goals and ensure the highest quality manufacturing
processes. Participates in QA training programs as required.
* Identify areas for improvement in manufacturing efficiencies and
* Assists with process, equipment, and cleaning validation
* Maintains gowning qualification as required.
* Trains, coaches, and mentors manufacturing associates on
downstream manufacturing functions, including compliance on all
company/regulatory quality systems, safety procedures, and
* Maintain a safe workplace ensuring that he/she is aware of and
observes appropriate safety and occupational health rules and
* Employee is required to attend safety training relative to
his/her position and report any infractions of safety procedures to
the facility Safety Officer
* Has good interpersonal skills, is attentive and approachable.
Discusses problems with colleagues and senior personnel.
* Maintains a professional and productive relationship with
supervisor and co-workers.
* Ensure high standards of cGMP are adhered to at all times
* Occasionally provides support to other areas within the PBF such
as fermentation or Fill/Finish activities.
* Other duties as assigned.
Candidates for positions under ICON Government and Public Health
Solutions contracts with the Department of Defense (DoD) may be
required to pass one or more background/security investigations
conducted by the DoD, U.S. Army, or other Federal Government
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative
of those that must be met by an employee to successfully perform
the essential functions of this job. Reasonable accommodations may
be made to enable individuals with disabilities to perform the
Laboratory/office environment; may require working evenings and
weekends. While performing the duties of this job, the employee is
occasionally required to stand; walk; sit; use hands to manipulate
objects, tools or controls; reach with hands and arms; climb
stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work
may involve long periods of standing and handling of numerous
chemicals and/or hazardous biological material. The employee must
occasionally lift and/or move up to 25 pounds. The noise level in
the work environment is usually moderate.
Equal Opportunity Employer/Protected Veterans/Individuals with
The contractor will not discharge or in any other manner
discriminate against employees or applicants because they have
inquired about, discussed, or disclosed their own pay or the pay of
another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as
a part of their essential job functions cannot disclose the pay of
other employees or applicants to individuals who do not otherwise
have access to compensation information, unless the disclosure is
(a) in response to a formal complaint or charge, (b) in furtherance
of an investigation, proceeding, hearing, or action, including an
investigation conducted by the employer, or (c) consistent with the
contractor s legal duty to furnish information. 41 CFR 60-1.35(c)
Keywords: Icon Government and Public Health Solutions, Silver Spring , Purification Specialist, Other , Silver Spring, Maryland
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