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Senior PD Scientist

Company Name:
NeoStem/PCT
Senior PD Scientist (IMMEDIATE OPENING!!!)
We are seeking highly motivated Senior Process Development (PD) Scientist who is interested in joining our fast-paced, dynamic environment.
This position requires that the ideal candidate be able to design and perform experiments and assays independently, with precision, and a high level of technical proficiency. The candidate must be able to plan, schedule and execute required tasks and activities across several projects simultaneously. Development activities include, but not limited to, tissue processing, isolation, enrichment, and manipulation of cells, cell and tissue culture, assay development to characterize cell populations and products, and assay development to assess activity and/or potency for cell products. The successful candidate must be able to work collaboratively with other team members across sites and projects. This position is based in Allendale, NJ.
Responsibilities:
Responsible for development activities such as tissue processing, isolation, enrichment, and manipulation of cells, cell and tissue culture
Performs assay development to characterize cell populations and products, and assay development to assess activity and/or potency for cell products
Development of processes for the manufacture of cell-based therapeutics, including yield and media optimization, process streamlining and cost of goods reduction
Scaling up of processes and enhancement of regulatory compliance
Development of final product formulations
Execution of stability series to include raw material, in-process intermediate and final product
Writing of development SOPs, development process production records and technical reports.
Performs any and all required processing and testing required to produce and assess safe and efficacious products.
Consistently produce a high level of documentation accuracy and clarity
Cryopreservation of products using DMSO solutions and rate-controlled freezers
Participating in client-based projects and studies, may include but not limited to: sample preparation, sample shipping, media and reagent preparation, ordering and receiving supplies, communicating effectively with supervisor, company management and client team members
Provides expertise and reporting techniques in the development of scientific and technical articles in conjunction with new business development
Contributes expertise to the Business Development Team when preparing Scope of Work and or proposals
Present results and updates at project team meetings and write project reports
Requires development of SOPs, work instructions and other documents for GMP production
Works with lead candidate products and advancing projects into clinical trials
Performs additional duties as assigned
Occasional travel may be required to internal PCT meetings and external client sites
Education and Experience:
Ph.D. or equivalent in biological sciences or relevant field
At least 10-15 years of experience in pharmaceutical or biotechnical/biopharmaceutical industry
Strong research background and training in cell biology, immunology, stem cell biology, molecular biology, biochemistry or related discipline
Must have hands-on experience in cell-based product manufacturing process development and qualification. This includes broad tissue culture experience (especially hematopoietic cells, primary cells and progenitor cells), aseptic technique, and experience operating and maintaining cell processing equipment, (including bioreactors, Cell Factories, COBE Cell Processors, Cytomate Cell Processors and magnetic separation systems).
Expertise in suspension and adherent mammalian cell culture, cell isolation, characterization and large-scale cell production
Extensive expertise with flow cytometric analysis and cell sorting, multipara metric immunophenotyping, instrumentation and data analysis software
Experience with cell isolation methods including, but not limited to, magnetic bead base separations, elutriation, gradient centrifugation, and antibody based separations
Broad working experience in molecular engineering, recombinant protein expression in various expression systems, recombinant protein or monoclonal antibody productions and purification. Other molecular biology experience such as PCR, and qPCR, microarray and microRNA analysis a plus
Must have the ability to handle multiple priorities, maintain confidentiality and interface with individuals from various departments and various companies at various levels.
MUST be Flexible and will be expected to contribute to an exciting, productive and scientifically rigorous working environment with flexible working schedules.
Ability to work in a fast-paced environment in results oriented fashion
Proficiency with computer applications for word processing, spreadsheet and document generation and other computer skills
Strong team-oriented, interpersonal skills are essential
Excellent organizational skills and attention to detail
Excellent verbal and written communication skills
About US
PCT, a Caladrius company is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market.
We challenge our employees to become leaders in the emerging field of cellular therapy. It takes a team of experts to help us lead the paradigm shift in medicine-- a shift away from just treating symptoms and towards finding cures for chronic disease and illness.
Connect with us on LinkedIn at http://www.linkedin.com/in/pctcelltherapy
Follow us on Twitter @PCTcelltherapy
If you are interested in this exciting opportunity, please send a copy of your CV or Resume directly to

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