This is Andrew Youngelson, Healthcare Technology Recruitment Director from
Key Recruit, Inc. I have a job opportunity you might be interested in---see
below.
Please Indicate by job ID which you are interested in!
Associate Director - Cell Culture & Fermentation
Date Posted: 9/6/2007
Job ID: 1565
Company: We are a biopharmaceutical company. We focus on the development of
protein pharmaceuticals for patients who need them. We were founded to
develop important commercial products through the use of biotechnology.
Since that time, we have created a focus in protein therapeutics and built a
robust pipeline of product candidates that address significant unmet medical
needs.
Location: Northern CA
Reports To: VP of Protein Science-Process Development
Salary: 125k-145k
Education: Ph.D. in Chemical Engineering or Life Sciences.
Requirements: 6+ years experience in the biopharmaceutical industry or MS in
Chemical Engineering or Life Sciences with 10 years experience. The ideal
candidate will have extensive hands-on experience with the development,
optimization and scale-up of perfusion and fed-batch cell culture processes.
Expertise in the use of a variety of cell retention systems used in
perfusion processes especially centrifugal systems is beneficial. Additional
expertise in the area of microbial fermentation is desirable. The candidate
must have experience in upstream process optimization, media optimization,
and process scale-up. Experience in tech transfer to pilot and cGMP
production environments and especially to CMOs is highly desirable. Detailed
knowledge of FDA and EU regulatory requirements is desired. The candidate
must have strong analytical and problem solving skills to optimize and
troubleshoot upstream processes. Strong verbal and written communication
skills are essential. Prior experience in managing and training staff is
essential. The candidate must have good interpersonal/small group skills
with the ability to motivate and supervise others and work effectively in a
multidisciplinary, team oriented matrix environment. The candidate must also
be willing to spend 30% of his/her time in overseas and domestic travel
especially in the first 12-18 months.
Duties: The Associate Director will be responsible for set up and management
of a mammalian cell culture/fermentation and microbial fermentation process
development facility and a upstream development team to support the needs of
Company's clinical and preclinical programs. The position will require
hands-on involvement in the set up and operation of the facility and the
training of staff in the upstream process development group. The incumbent
will also manage activities at contract manufacturing organizations (CMOs)
related to process optimization, scale-up, clinical manufacturing and Phase
III/commercial manufacturing. The upstream development group will be
responsible for process development, optimization and troubleshooting of
both perfusion and fed-batch based processes. The incumbent will be
responsible for developing, scaling up and improving cell culture and
microbial fermentation based manufacturing processes in collaboration with
external parties and internal groups in downstream process development and
bioanalytical areas. The position requires the ability to develop and
optimize upstream processes in accordance with regulatory requirements for
Phase III/commercialization. The individual will also be responsible for
identification and implementation of improved technologies for R&D and
commercial manufacture to enhance product quality, manufacturing cost
efficiencies & regulatory compliance.
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Hematology Research Scientist
Date Posted: 9/6/2007
Job ID: 1567
Location: Northern CA
Reports To: Director Reseach
Salary: 115k-130k
Education: Ph.D.
Requirements: 5 or more years of experience working in the area of
hematology research. A strong record of productivity as evidenced by
peer-reviewed publications, abstracts, and presentations.
Duties: Is highly accomplished in all aspects of hematology including in
vitro assays of clotting time, FXa generation, ROTEM, and thrombin
generation, as well as in vivo assays of clotting and/or thrombosis. Takes
responsibility for multiple workstreams. Manages one or more research
assistants. Works within a closely integrated team. Communicates clearly and
directly with all co-workers. Is a proficient writer, with a full command of
English and a clear and logical style. The following work habits and
behaviors are essential for success in the position: Is an independent,
critical and creative thinker. Provides input to on-going workstreams, new
projects and novel experimental approaches. Interacts productively with all
other members of the project team. Is prepared to go beyond the usual work
schedule to accomplish critical tasks. An understanding of hematology
including bleeding disorders and thrombosis are advantageous.
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Process Development Scientist - Protein Formulation
Date Posted: 9/6/2007
Job ID: 1566
Location: Northern CA
Reports To: Director Reseach
Salary: 115k-130k
Education: Ph.D. in Pharmaceutical Chemistry, Biochemistry, Chemical
Engineering, or a related discipline.
Requirements: Proven track record within protein formulation and at least 5
years of pharmaceutical or biotechnology industrial experience developing
formulation for biopharmaceuticals. Experience in using clinically
acceptable excipients suitable for the intended route of administration to
support preclinical and clinical studies is essential. Familiarity with ICH
guidelines for evaluating the stability of drug substance and drug product
is essential. Previous in-depth experience and expertise in liquid and/or
lyophilized formulation development for PEGylated proteins and coagulation
factors is beneficial. Experience in the evaluation and implementation of
syringe devices for self administration is a plus. Experience in high
concentration protein formulation process development is highly desirable.
Must be able to work efficiently in a matrix environment and interact with
colleagues in Downstream Purification Development and Analytical Development
to coordinate project progression. Previous in-depth experience and
expertise in the various biophysical and physicochemical methodologies for
characterization of proteins and their degradation pathways is highly
desirable. Familiarity and experience with fill finish operations in a GMP
environment is a plus. Previous experience in optimization and scale up of
lyophilization processes is beneficial. Experience in freeze/thaw of liquid
bulk drug substance is highly desirable. Excellent communication (oral and
written) skills are essential. Familiarity with regulatory documentation,
previous experience with IND/IMPD/BLA authorship for regulatory submissions
is preferred.
Duties: This individual will be responsible for protein formulation
development for both early and late stage programs in Company's pipeline.
The position will require some hands-on work and also the management of
formulation development activities at external contract research
organizations (CROs). Knowledge in the development of both liquid and
lyophilized protein formulations is necessary. The position requires
evaluation and implementation of syringe devices designed for self
administration. The individual will be required to develop protocols for
evaluating protein formulations under accelerated and long term stability
conditions. Management of stability studies for our ongoing clinical
programs. The position requires expertise in the use of standard
instrumentation and methodologies for evaluating protein stability and the
knowledge of the ICH guidelines for ensuring the stability of protein
pharmaceuticals. The candidate may attend formulation development meetings
and scientific meetings to remain current with development technologies and
regulatory guidelines pertaining to CMC activities. The position will
require some travel.
Visit www.keyrecruit.com to view other openings.
As always thanks for passing on!
Andrew Youngelson
Key Recruit Inc.
www.keyrecruit.com
If Interested
Email me; attach your resume as a Word document. And tell me your current
salary, Include a cover letter explaining why you would be a good fit for
this position using the using the keywords in the job requirements and
duties as a guide.