Purification Specialist

Company: Icon Government and Public Health Solutions
Location: Silver Spring
Posted on: November 12, 2019

Job Description:

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 essential functions.

* Supports successful implementation of new products and processes into the facility.

* Assist with technology transfer from Process Development to manufacturing environment.

* Plan, order and account for consumption of raw materials and components.

* Prepare (wipe down) equipment and supplies for use in cleanroom environment.

* 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 skids.

* Ensures that standard operating procedures (SOPs) and batch records are accurate, and followed in accordance with cGMP regulatory expectations.

* 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 and weekends.

* 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 requirements.

* 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 targets.

* 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 compliance.

* Assists with process, equipment, and cleaning validation initiatives.

* 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 SOPs.

* Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.

* 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 agency.

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 essential functions.

WORK ENVIRONMENT:

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.

EqualOpportunityEmployerDescription

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

PayTransparencyPolicyStatement

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