Head of Manufacturing & Process Development:
Start-up a pilot lab for protein production, develop processes and procedures, influence decisions made toward clinical trials and be responsible for the lab's ongoing operation. 5+ years in development and optimization of intermediate scale cell culture (E Coli) and purification processes and technology transfer, program management and cGMPs .
Sr Process Scientist (Manager/ Assoc Director Level)
The scientist will be tasked with the process scale-up of a Mammalian cell BHK facility for a recombinant Protein to be used in a pharmaceutical - blood product. Emphasis is on upstream process development work i.e. BioReactors- perfusion, aspiration- Previous experience growing the cells cleanly and efficiently up to 500 liters. 5+ years of production experience in downstream purification of recombinant proteins utilizing the latest techniques to insure optimum yields. MS with 8+ years experience or Phd and 5+ years commercial exp in accordance with cGMP and FDA guidelines
Tasks would include Optimization of dosage formulation, Scale-up from research to production batch size. Process validation Process transfer to manufacturing, Protocol and final report writing Experience in development of solid, semi-solid or liquid dosage forms Hands-on experience in process optimization, scale-up and validation for final dosage form This person will be working on various projects, and well as supporting ongoing development projects. BS or MS and 2-4 years of industrial experience.
Medicinal Peptide Chemist
This person will have demonstrated experience in modern synthetic methods, spectroscopy and separations techniques. Ability to plan and execute syntheses of compounds required in lead identification and lead optimization of small molecule and Peptide based oncology and endocrinology drugs. Demonstrated experience executing multi-step organic syntheses as well as parallel synthesis .This person will be working on various projects, and well as supporting ongoing research and development projects. BS or MS and 2-4 years of industrial experience or Phd with 1-2 years of industrial Experience.
Director - Pre Clinical / Vivo Pharmacology
Oversees and develops all Pre-Clinical - In Vivo pharmacology and toxicology studies required for IND & NDA.Design and interpret En Vivo, ADME, DMPK studies across a variety of compound and indications. Develop, implement and optimize functional assays for the pharmacological characterization of compounds. Participate in overall product development strategy, strategy development and management of various Vascular / Cardiac Studies.Ph.D. in Toxicology, Biology, Chemistry, PharmD .
Director - Clinical Operations
Establish clinical conduct infrastructure including but not limited to: documentation, clinical trial management systems, safety data collection and management and review/revise clinical research Standard Operating Procedures to ensure applicability. Establish clinical research programs to meet the strategic objectives of the organization: Coordinate efforts to develop studies designed to meet the regulatory registration and/or marketing objectives. Define efforts and resources (financial, personnel and time) to meet program plans. Requires an advanced science or business degree. Ph.D. preferred.Minimum of 10 years experience in the medical device, biotech and/or pharmaceutical industry.
Senior CRA / Clinical Project Manager
Assist in the management of clinical phramaceutical trials, protocol and case report form development, investigator recruitment, and collection of critical study documentation. Act as lead monitor and may assume or assist with project management. Recruit investigators, negotiate study budgets, collect critical study documentation, assist in preparation of protocols and CRFs; prepare clinical study reports. Conduct pre-study, initiation, routine, and final monitoring visits, requiring up to 25% travel. Phase 2-3-3b Trials experience with the following indications Oncology, Hematology, Cardiac, CNS. BA/BS (preferably in a life science) or RN, CCRA certification a plus.
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