Pharmalink Consulting is recruiting for a Regulatory Submission Manager who will coordinate all aspects of CMC regulatory submissions relevant to their assigned projects and serve as the regulatory CMC representative on matrix teams, as appropriate.
Duties and Responsibilities:
Monitor changes to development plans and work with supervisor to design globally compliant CMC regulatory strategy for development products with supervision.
Drive global CMC regulatory submission activities (IND, CTA, ...
Temp Scientist/Associate Scientist/Scientist for PI3K Sequencing Project
Work with a development team to contribute to molecular diagnostic research and development projects.
Major responsibilities include but not limited to:
Perform some planning and design of experiments with moderate guidance.
Independently execute experiments with good quality, including sample preparation, PCR, RT-PCR, DNA sequencing, cell/tissue culture, etc.
Work on experiment data collection, summary and report. ...
Work closely with the development team to contribute to the development of real-time PCR based IVD tests.
Perform some design of experiments with moderate guidance.
Independently execute experiments with good quality, including sample preparation from FFPE tissue samples, real-time PCR and cell culture.
Pay attention to technical details and conduct effective troubleshooting when needed.
Maintain detailed experiment records in lab notebooks in compliance with company ...
Seeking a Director of Manufacturing to oversee the scale up, tech transfer and large scale production of biologic products such as Antigens, Antibodies, Proteins or Reagents.
Shall have expertise in aseptic biologics manufacturing, various cell culture methods, protein purification, and fill-finish methods.
Will be responsible for managing daily operations of a biologic manufacturing facility including plant design, procurement of equipment, budget planning, vendor relations, etc.
our client is looking for an associate scientist in cambridge, ma. this is a long term position.
Job Description We are seeking motivated and creative individuals to join our Cell Line Development team through April 2013 and contribute to ongoing efforts to engineering superior host cell lines for the manufacturing of therapeutic proteins. The successful candidate will have mammalian cell culture/cell line development experience. Candidates with experience performing transfections, basic molecular ...
The candidate will be responsible for conducting in-vitro and in-vivo studies, analyzing metabolites from a variety of matrices and interpret MS/MS data in support of discovery and early development projects. The scientist will use-state-of-the-art mass spec and other analytical technologies. This position requires a BS/MS in Chemistry/Biochemistry and related discipline with 1-5 years of experience in the pharmaceutical industry performing in vitro biotransformation studies, experience with use of ...
our client in cambridge, ma is looking for an associate scientist with redox potentiometric experience. This is a long term consulting position. If interested, please apply to this ad
Job #: 13-01484
job title: Associate Scientist, Redox Potentiometric measurements
The candidate will support application of redox potentiometric measurements for development of analytical tools to monitor the oxidation of polysorbates and therapeutic proteins. Primary responsibilities include method development, ...
PS Order #: 92749
Title of Position: Quantitative Protein Biomarker Scientist
Location: City/State: Andover, MA
Contract Length: 12months
Target Start Date: 11/25
Qualifications, Technical Skills and Experience: • BS/MS level education in biochemistry, biology or chemistry or related fields required; advanced degree may be a plus. • Industry experience in biopharma preferred. • Extensive expertise in the operation and maintenance of mass spectrometers. • Experience with basic ...
Nov 1 -
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