Senior Scientist/Group Leader - Analytical Development

A great company in Tarrytown, NY is seeking a Senior Scientist/Group
Leader-Analytical Development. Would you be interested in pursuing an
opportunity such as this? If so, please review the details below. If not,
please consider referring a colleague. Either way, thank you so much for
your time - have
a great day!

Responsibilities:

Assist the Director of Analytical Development with:

Primary Duties:
Development, optimization, and performance of characterization assays
designed to establish the primary, secondary and tertiary structure of
antibodies.
Technical writing of documents such as SOPS, investigation reports, assay
development and validation reports, and assay transfer protocols and summary
reports.
Interact with contract laboratories to establish service agreements, review
assay transfer and validation protocols, review and approve characterization
test results, and support investigation or trouble-shooting activities as
needed. Development, optimization and performance of HPLC and spectroscopic
test methods to establish the conformational aspects and structure-function
relationships of antibodies.

Secondary Duties:
Review test results and laboratory notebooks prior to approval. Develop
protocols for antibody characterization and comparability studies.
Preparation and participation in project management activities related to
product team meetings. Provide backup support to Director, Analytical
Development.

Requirements:
Requires a Ph.D. in Analytical Chemistry or Protein Chemistry.
Experience in Biologicals analytical development laboratories that includes
5 or more years associated with:
Monoclonal antibodies and recombinant technology-derived protein product
development.
Development, transfer, and qualification of new analytical methods in
protein chemistry and antibody chemistry.
Demonstrated competency in the technical writing including SOPs, analytical
method development/antibody characterization reports, etc.
Performance of standard physico-chemical and conformational methods for the
characterization, and degradation pathway studies of clinical trial product
lots.
Hands on experience with the ion-exchange, hydrophobic and reversed phase
chromatographic test methods for antibodies.

Other requirements:
Knowledge of the GMPs as they relate to manufacturing and the Quality unit.
Attentive to details; strong communication and coaching skills;
team-oriented; comfortable with direction from Directors and peers.
Willing to travel if needed. Identify and implement continuous improvement
of characterization assays.

Apply:
If you are interested in applying for one of these positions, please forward
your Word formatted resume, cover note and salary requirement to
resumes@.... Please include the specific position to
which you are applying in the subject line of your email. This will ensure
your resume is routed to the correct recruiter as quickly as possible.

We offer a referral 'bonus' program. Here are the details:
http://www.workwondersstaffing.net/CandidateResources/Referrals.html