US-NJ: Clinton-Director of QC & Analytical Development
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Job Title: Director of QC & Analytical Development
Job Location: NJ: Clinton
Pay Rate: Open
Job Length: full time
Start Date: 2003-11-02
Company Name: ETS INC
Contact: Recruiting Administrator
Phone: 267-880-1650
Fax: 267-880-1655
Description: Jobcode: DQCAD-JAW
Position: DIR OF QUALITY
CONTROL AND ANALYTICAL DEVELOPMENT
Location: CLINTON, NJ (Actual Location:Annadale)
DUTIES:
Leads the site Quality Control (QC) unit, including supervision and conduct
of all laboratory operations. Directs the QC laboratory operations
responsible for stability programs; and, for the commercial testing and
release of drug substance, intermediate bulk, and finished drug product
sourced primarily through third party supply partners. Responsible for the
overall regulatory compliance profile and documentation systems within
laboratory operations. Works directly with multi-disciplinary groups within
both Pharmaceutical Process Development (PPD) and Commercial Operations, in
order to effectively support the overall technology management strategy for
product candidates across their full life-cycle. Staff position would
interface with chemical, formulation, device and manufacturing development
functions to provide analytical services in support of transfer and
validation activities required to ensure successful commercialization.
Activities would include matrix management and participation in
cross-functional teams throughout the development and commercialization
process, in order to meet on-going clinical supply needs, satisfy CMC
documentation requirements, achieve regulatory approval with product
specifications harmonized across multiple markets, and successfully
launch/support new products; Directs QC Laboratory Operations responsible
for raw material, bulk intermediate, and finished goods testing and release
for existing products sourced primarily through third party contractors.
Conducts both registration and marketed product stability programs in
support of both new and existing product commitments. Owns accountability
for regulatory compliance and safety performance within the laboratory
operations. Interfaces with PPD disciplines to provide analytical services
in support of materials characterization and methods development, transfer
and validation for new product initiatives. Proactively collaborates with
Regulatory, Development and Operations functions to meet CMC deliverables
and achieve timely regulatory approvals; Leads and participates in
cross-functional teams as required to meet relevant clinical supply
requirements, and manage key analytical deliverables associated with
development and commercial launch of new product candidates; Manages cost
center capital and expense commitments; Supports due diligence initiatives
associated with evaluation of in-licensing opportunities;
REQUIREMENTS:
Ph.D. in Chemistry, Pharmaceutical Chemistry or related scientific
discipline with 8-10 years related experience. Solid history of
accomplishment and demonstrated performance with a minimum of 5-10 years
broad based experience in analytical chemistry/quality control operations.
Previous technical and/or management experience in pharmaceutical, medical
device or biotech operations with thorough working knowledge of regulatory
guidelines, and cGXP practices. (Experience in aerosol and sterile product
methods a plus.) Strong leadership, organizational planning and project
management skills required to lead multi-disciplinary teams organized across
disperse geographic locations, and coordinate multiple projects in a
demanding, fast-paced laboratory environment. Excellent interpersonal
effectiveness and communication skills (written & oral) required in order to
interface across management levels and functions both within the company and
with key supply partners. Strong business and technical skills required, in
order to effectively anticipate and meet key analytical and overall
commercialization objectives.
DESIRED:
10-15 years related technical and/or management experience in analytical
chemistry/quality control operations within the pharmaceutical, medical
device, or biotech industries
If interested, please forward a copy of your resume in MS Word format to
Jason Wood, Recruiting Consultant at ja...@eagle-staffing.com.
Applicant must be a U.S. resident or currently able to legally work in the U.S.
Please refer to Job code DQCAD-JAW when responding to this ad.
For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/366063.html to apply online.
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