GTC Biotherapeutics (fka GTCB)

[floblu14]

is an inhaled rhAAT a possibiltiy for GTC since it has a patent application for >USE OF AEROSOLIZED ANTITHROMBIN TO TREAT ACUTE LUNG INJURY< ?

http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=EP1713500&F=0


also, check out GTC's new "flo" chart - I particularly like the green star & LFB inclusion -
http://www.gtc-bio.com/products/prod.html


also, as of today, there are new positions posted -

Process Development Scientist
Responsible for developing robust/scaleable protein clarification/purification processes for GTC’s therapeutic protein products. Conduct various bench scale process development experiments. Identify critical process parameters and establish operating ranges for optimum recovery/yield. Participate in scale-up of developed processes to pre-clinical, clinical and commercial scale with consideration towards process efficiencies and costs projected for full scale operation. Familiarity with typical analytical methods used for evaluating proteins. Experience in a GMP environment regarding CMC activities. UF/DF, filtration, viral clearance, process chromatography, TFF, DFF, centrifugation, HPTFF, fractionation understanding is necessary.

This position requires a degree in Chemical Engineering or relevant engineering discipline with broad knowledge and application of basic theories, principles and techniques in bioprocess engineering. Experience working with recombinant proteins and analytical techniques related to area of expertise, such as cell culture, separation sciences, pharmaceutical development, biochemistry, or analytical chemistry is preferred. Strong interpersonal communications, organizational and problem solving skills needed as well as a successful demonstration of working independently and as part of a team.

Associate Director/Director Formulation and Analytical Development
Responsible for protein formulation development and analytical development activities in support of GTC pre-clinical and clinical programs. Conduct pre-formulation experiments (e.g., pH-stability, pH-solubility) on protein candidates to characterize strengths and weaknesses and devise appropriate formulation strategies. Develop injectable (liquid/lyophilized) pre-clinical formulations of various protein Biotherapeutics to support pharmacokinetics, efficacy studies and toxicology.

A degree in Pharmaceutical Sciences, Biochemistry is required. PhD and five years experience or MS and 10 years experience is required in protein formulation and protein analytical development. Familiarity with FDA requirements, ICH guidelines and GMP guidelines.

Scientist, Formulation and Analytical Development
Responsible for conducting studies in support of protein formulation development and analytical development activities. Conduct pre-formulation experiments (e.g., pH-stability, pH-solubility) on protein candidates to characterize strengths and weaknesses and devise appropriate formulation strategies. Perform laboratory studies on candidate injectable protein formulations (liquid/lyophilized) to identify pre-clinical formulations to support pharmacokinetics, efficacy studies, and toxicology. Perform studies on candidate formulations to support clinical tries. Familiarity with typical analytical methods used for evaluating proteins. Familiarity and experience in a GMP environment regarding CMC activities.

MS/BS in Biochemistry is required along with 3 – 5 years experience in protein formulation or protein analytical development.

Process Development Associate
Responsible for performing a variety of basic laboratory procedures related to process and analytical development for GTC’s recombinant proteins. Perform various bench scale process development procedures including buffer preparation, clarification of transgenic milk by centrifugation, and concentration/diafiltration of protein solutions. Perform various analytical procedures needed to support process development activities. This includes SDS-PAGE and western blotting. Participate in scale-up of developed processes and transfer to manufacturing or QC. Familiarity with basic laboratory procedures, including centrifugation and filtration. Familiarity with procedures related to protein purification and characterization (chromatography, electrophoresis) is a plus. Strong interpersonal communications, organizational and problem solving skills needed as well as a successful demonstration of working independently and as part of a team.

This position requires a degree in biology or chemistry with 0-2 years experience. Experience working with basic protein purification and characterization techniques is preferred.

Regulatory Affairs Manager
Responsible for long- and short-term planning and directing of Chemistry Manufacturing Control (CMC) regulatory activities. Interprets corporate policy, develops and implements strategies for the earliest possible approval of regulatory submission, advises and manages the regulatory teams, and reviews ongoing projects. Plans, schedules and directs activities and programs through regulatory staff. Negotiates with outside agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of product and services. Reviews and prepares responses to inquires from regulatory authorities relating to product registrations. Monitors and updates national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel. Communicates pertinent changes and updates to regulatory staff and senior management. Oversees the preparation and submission of applications and routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal department (Manufacturing, QA/QC, Medical, etc.) to update registered product information. Provides input on budget requirements, and monitors project and program costs.

This position requires a BS/MS in a scientific field and 8 years experience.

Regulatory Affairs Specialist
Ensures all company products meet worldwide regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/ interpretations. This may include the review, evaluation, and compilation of files and reports for submissions. Provides project team representation and direction in managing information from/to other departments (including R&D, Manufacturing, Quality Assurance, Quality Control, Medical Affairs, Marketing, and Clinical Affairs) regarding Regulatory submissions. This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments. Reviews technical and clinical documentation and recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Is responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies. Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes. Responsible for corporate archive of assets. Maintain FDA and EU correspondence

This position requires a degree in biology or chemistry with 4 years related experience. Candidate must be proficient in MS office products. Strong interpersonal communications, organizational and problem solving skills needed as well as a successful demonstration of working independently and as part of a team.
http://www.gtc-bio.com/about/career.html