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Contract Manufacturing Manager
Candidate will be responsible
for facilitating the transfer of information
between the development and manufacturing groups
and outside contract manufacturing partners.
Will be responsible for: maintaining a database
of current contract manufacturers and their
capacities; interacting with the process development
and manufacturing groups to answer process related
questions; arranging teleconferences with CMO’s
to facilitate the transfer of developed antibody
manufacturing processes; maintaining a good
working relationship with selected CMO’s; setting
up meetings between Medarex and CMO personnel;
tracking the status of action items from meetings
and following up on those items; maintaining
a record of information transferred to and received
from the CMO; obtaining general information
from selected CMO’s; working with some service
providers to obtain answers to Medarex inquiries
and assisting in additional tasks when needed.
Up to 50% travel required. Applicants should
possess a BS/BA in a science related field.
Requires an understanding of mammalian cell
culture, protein purification, and/or fill/finish
operations in a GMP environment. Five years
of manufacturing or operations technical support
work in a GMP biologics facility.
apply
for this job now
or
email us your resume
(include the title and location of the job)
GCP Auditor (NY)
Position is responsible for
performing internal audits of clinical research
in compliance with FDA regulations and internal
SOP's. Specifically, review of CRF's for accuracy/consistency;
auditing study documentation; assisting with
site audits; identifying areas for GCP training
needs and creating and maintaining data tracking
tools. Requires a Bachelor's Degree in a scientific
discipline and a minimum of 5 years pharmaceutical
experience in either compliance, clinical research
auditing or CRA role. Knowledge of FDA regulatory
requirements and GCP guidelines. Nursing background
is a plus+.
apply
for this job now
or
email us your resume
(include the title and location of the job)
QA
Manager (NY)
Conduct various types of audits including clinical
investigator site, sponsor, vendor, submission/document,
and internal systems/processes; plan and carry
out audits; prepare timely QA reports documenting
audit results; interact with various teams to
ensure corrective actions and bring QA observations
to closure; maintain audit database information,
ensuring accuracy and completeness; provide
oversight for audits delegated to external consultants
or other third parties; maintain working knowledge
of SOPs and relevant regulations/guidelines;
provide GCP guidance and training to customers,
clinical investigators, etc.; interact with
multiple functional groups to support the development
and implementation of process improvements and
effective QC processes; participate in the development
and implementation of procedures to promote
standardization within the QA group. 3 years
in clinical research or regulatory affairs with
at least 2 years auditing experience (GCP preferred).
apply
for this job now
or
email us your resume
(include the title and location of the job)
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