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Integrated BioTherapeutics, (IBT) Bioservices, located in Rockville, MD, offers a highly stimulating scientific environment. We believe in teamwork and integration of talent from many disciplines. Here, you will interact with internationally renowned scientists and get involved in collaborations with leading research laboratories and the biotech industry.

Integrated BioTherapeutics is an equal opportunity employer and provides a positive working environment. 

Eligible applicants should send a cover letter, resume and names and contacts of three references to jobs@IntegratedBiotherapeutics.com

 

Current Open Positions:

Associate Director / Director of Quality Assurance

Integrated Biotherapeutics

Job Description

Integrated Biotherapeutics (IBT) is a clinical stage biotechnology company with an exciting pipeline of vaccines and antibody therapeutics. Located in Rockville, MD, the company has both a significant product development focus, and offers reagents and analytical testing services to the biotechnology industry through its IBT Bioservices division. The company offers a highly stimulating scientific work environment and believes in teamwork and integration of talent from many disciplines. Here, you will interact with internationally renowned scientists and become involved in collaborations with leading research laboratories in pursuit of your goals.

IBT has an immediate need for an Associate Director / Director of Quality Assurance.  The title offered to the prospective candidate will be commensurate with his or her level of experience in the biotechnology industry. The principal responsibilities of the candidate will be to establish and maintain a Quality Management System (QMS) to support regulated testing, including testing following Good Laboratory Practice as defined in 21CFR part 58. The position reports to the VP, Programs and Operations.

Responsibilities and Job Function

  • Provide Quality oversight of GMP-compliant manufacturing performed at contractor sites
  • Work with vendors performing contracted studies to establish Quality Agreements
  • Qualify vendors for contracted manufacturing and other regulated work
  • Serve as IBT’s Quality authority in the investigation of deviations, corrective and preventative actions (CAPA) and in change control
  • Review manufacturing batch records and other records related to regulated testing as part of the approval process for release of investigational products
  • Provide oversight over the design and execution of stability studies performed on GMP products
  • Work with the IBT Senior Management Team to establish an appropriate Document Control System
  • Expand IBT’s QMS through the generation of SOPs and policies that support release of investigational product for clinical use
  • Build upon IBT’s current Quality infrastructure to establish and in-house GLP-compliant testing capability
  • Provide oversight for IBT’s internal regulated testing program to ensure that all Quality aspects of testing, including design and execution of assay qualification and validation protocols, control of critical reagents, and physical infrastructure are in compliance
  • Ensure that employees are trained as appropriate on policies and procedures pertaining to the QMS
  • Establish strong relationships at IBT and with IBT’s business partners to enhance and ensure quality awareness
  • Develop and monitor appropriate metrics to track quality and process improvement

Required Education and Experience

  • Bachelor’s degree in biological sciences or related field; advanced degree(s) preferred
  • Minimum of 5 years (for Associate Director) to 10 years (for Director) in GxP environment, with at least 5 years of GLP/GMP Quality Assurance experience
  • Experience as a successful contributor in the Quality department in the pharmaceutical, biotechnology field
  • Expert knowledge of USP, GxP, FDA, and EMA regulatory requirements and guidance applicable to biopharmaceuticals
  • Broad understanding of contemporary quality practices as they apply to product development, product testing and GMP manufacturing
  • Experience in establishing and maintaining Quality infrastructure at a small to mid-sized company
  • Demonstrated ability to accomplish goals with fellow employees who are not direct reports
  • Strong sense of ethics and honesty
  • Strong written and verbal communication skills

Integrated BioTherapeutics is an equal opportunity employer and provides a positive working environment. 

Eligible applicants should send a cover letter, resume and names and contacts of three references to jobs@IntegratedBiotherapeutics.com

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IBT Bioservices continues to conduct critical work as an essential business under the State of Maryland’s COVID-19 response directive. We have implemented a risk management plan and are continually monitoring the situation to ensure continuation of research according to public health services recommended best-practices for keeping our employees and the community safe. 

The IBT Bioservices team will continue to deliver high quality products and services for every project. If you have any questions contact us at Services@IBTBioservices.com