Purification
Suite Manager
A pharmaceutical company located in New York is seeking
a Purification Suite Manager to be accountable for ensuring
the technical success of production operations within
the Biotechnology purification suite. As a key member
of the Manufacturing Leadership Team, the Manager is
responsible for leading the successful execution of
manufacturing operations in a multi-product biopharmaceutical
facility. The Manager will be responsible for meeting
production demands and delivering drug substance in
a safe, high-quality, cGMP compliant, reliable and cost
effective manner. The Manager will also participate
in setting department objectives for staff development,
safety, quality, efficiency and continuous improvement.
The Manager will be expected to collaborate with Process
Development, Technical Services and Quality Assurance
to enhance performance and ensure safety and cGMP compliance
within the facility.
Position Requirements:
The successful candidate will have a M.S. Degree in
Engineering, Biochemistry, or appropriate technical
discipline with 5 to 10 years of directly related experience.
Prior manufacturing experience in the biotechnology
or pharmaceutical industry is required. Proven experience
with large-scale chromatography, filtration and viral
clearance procedures is highly desirable. Must have
expert knowledge of cGMP standards, a proven record
of leading cGMP compliant operations and the ability
to drive quality improvements. The successful candidate
must have demonstrated the ability to manage and develop
people and a history of leading and participating on
cross-functional teams.
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Manager,
Validation Services
A pharmaceutical company located in New York is seeking
a Validation Services Manager to be responsible for
the strategic and technical direction of the Validation
Services group within the Bioprocess Engineering Department.
The successful candidate will support the company's
biotechnology manufacturing organization by ensuring
the development and execution of process support validation,
cleaning validation, CIP and equipment and facility
qualification, IQ, OQ, PQ and SIP, studies. The Validation
Services Manager will supervise a multifunctional staff
of approximately 15 full time and contract individuals.
In addition, the candidate will identify additional
opportunities within the manufacturing facility to leverage
the resident technical expertise of the group, make
formal recommendations to address these opportunities
and drive the recommendations to completion. The candidate
will be expected to mentor and develop staff within
Validation Services. The candidate will also provide
technical support in generating regulatory responses
and submissions. The candidate will be expected to interact
with domestic and international regulators as required.
Position Requirements:
The candidate must have a BS or MS in Engineering or
Biological Sciences or Chemistry and 5 to 10 years of
relevant validation experience. The candidate must have
demonstrated verbal, written, and presentation skills
and have a successful record of managing validation
personnel and projects. The candidate should have relevant
regulatory experience, including the preparation of
regulatory submissions and responses and interactions
with federal and international regulators.
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