Vaccinex, Inc. is a biotechnology company engaged in the discovery and development of therapeutic monoclonal antibodies and other biologics to treat a variety of serious human diseases. Vaccinex is currently advancing several lead therapeutic monoclonal antibody drugs through non-clinical and clinical development, and continues to expand its pipeline of promising product candidates. Founded in 1997, the company has enjoyed significant and sustained funding, allowing it to build a strong research and development teams. The company is proud of its progressive team culture, and offers an outstanding career development opportunity in a fast-paced, dynamic and professional work environment.
The Clinical Supplies Coordinator is responsible for oversight of the labeling, packaging, distribution and return of Vaccinex’s investigational drug products used in clinical trials throughout the World. This individual serves as the liaison between clinical sites, CROs, and the company in the management of all aspects related to clinical trial material distribution.
- Work with 3rd party drug labeling, packaging, and distribution vendors to schedule labeling/packaging campaigns to meet clinical trial demand and timelines for multiple clinical trials.
- Review and approve documentation related to project setup and management of clinical trial supply and returns at the 3rd party vendors.
- Work with 3rd party vendors to establish, test, and implement Interactive Response Technology (IRT) for the distribution and tracking of clinical trial material for multiple clinical trials, including both blinded and open label studies.
- Monitor investigational product levels at the clinical sites and depots and work with internal stakeholders to ensure sufficient supply.
- Review and approve clinical trial material label text against regulatory requirements.
- Review and approve batch records for clinical trial material label and packaging operations.
- Author deviations/investigations for all clinical trial material supply related issues, such as temperature excursions.
- Author change controls for clinical trial material supply related changes.
- Serve as the liaison between Contract Research Organization and the 3rd party vendors for clinical supply related issues.
- Update study proposals in coordination with vendors as study designs change.
- Support clinical supply vendor audits.
- Review Specifications and perform User Acceptance Testing on Interactive Response Technology (IRT) (IWRS) systems used in drug supply management.
- Assist CMC Project Management as required.
- B.S./B.A. degree in biological or physical sciences and at least 3 years of experience in the regulated bio/pharmaceutical or medical device industry, or a combination of some science education and at least 8 years of relevant bio/pharmaceutical industry work experience is required.
- Scientific/technical background in the manufacture, laboratory testing, release, packaging & labeling, and distribution of therapeutic biologic products (e.g., therapeutic monoclonal antibodies, vaccines), and specific experience in clinical drug supply in the bio/pharmaceutical industry, is strongly preferred.
- Knowledge of refrigerated cold chain requirements for bio/pharmaceuticals or vaccines and experience with parenteral drugs is also strongly preferred.
- Strong interpersonal and team skills and the ability to manage multiple initiatives and projects simultaneously is required.
- Excellent written and oral communication skills and the ability to work independently and as a team member is required.
- Competency in computer programs such as Microsoft Word, Microsoft Excel, Microsoft PowerPoint and Microsoft Project is required.
- Working knowledge of FDA regulations related to cGMPs (21CFR Parts 210/211) is highly preferred.
Please Note: Due to the high volume of responses, only inquiries from qualified candidates can be addressed.
No telephone inquiries or recruiters, please.
Vaccinex, Inc. is an equal opportunity employer.
Please send resume via e-mail to email@example.com.