Manager,
Technical Support Facility
A pharmaceutical company located in New York is seeking
a Manager, Technical Support Group whose primary roles
are to provide direction to technical support staff
and to provide oversight for operations in the technical
support team.
The manager is responsible for ensuring adherence to
relevant procedures, policies and guidelines in the
conduct of projects performed by the technical support
team. The manager also serves as the key contact for
internal customers using the technical support team.
The manager is also responsible for maintaining an active
safety program, preparing and executing the technical
support team capital plan and preparing and managing
the technical support expense budget. The technical
support team provides critical support for productivity
improvement, process validation, technology transfer
and process support projects within Biotechnology Development.
Requirements:
The successful candidate will have a BS/MS degree in
Chemical Engineering or Biological Sciences with relevant
experience. Familiarity with biologic products is preferred
but not required.
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Associate
Director, Product Development
A pharmaceutical company located in Connecticut is
seeking an Associate Director, Product Development for
the following responsibilities:
-As a key member of the Pharmaceutical Technology Team,
Provide scientific leadership to Product Development.
-Contribute to seamless project flow from early stage
development to commercial production and build transparency
with the marketing -rganization for product definition.
-Manage all stability activities, both in-house and
with contract laboratories
-Maintain high level of knowledge related to current
developments in formulation science, particularly as
it applies to inhalation technology.
-Analyze competitor's products and develop strategies
to maintain effective advantages.
-Responsible for writing development proposals, comprehensive
and conclusive project reports, other management reports
and relevant sections of FDA submissions.
-Build partnerships with both internal and external
customers, i.e., QA, regulatory, sales and marketing,
project management and commercial manufacturing.
-Build, mentor and develop scientific and leadership
depth within the organization
-Organize and direct assigned projects, establish project
teams and develop individual and project team objectives.
-Initiate external collaborative arrangements, evaluate
technical merit, summarize results obtained and determine
impact on total development plan.
-Maintain current awareness of any applicable patents
affecting the project/product and initiate submission
of patents as appropriate
Requirements:
-10+ years of pharmaceutical development experience
-Experience and understanding in the drug development
process
-Prior experience in the use of six-sigma and process
excellence tools; Good understanding of design control,
FMEA and risk assessment
-Demonstrated ability to comply with cGMPs in a practically
viable way as they apply to drug development.
-Strong knowledge and demonstrated use of statistics;
strong analytical skills and the ability to rapidly
analyze information
-Solid understanding of Quality System Regulations (QSR)
-Prior experience with regulatory issues related to
FDA, OSHA and EPA and the ability to apply these regulations
to business needs
-Ph.D. in Chemistry, Pharmaceutical Sciences or equivalent
discipline, desired. OR
-M.S. in Chemistry, Pharmaceutical Sciences or equivalent
with 15+ years
-Possess critical thinking skills with the ability to
make solid decisions in the face of limited information
-Excellent interpersonal skills to allow effective participation
in project teams and the ability to work collaboratively
across a number of disciplines and functional groups
-Excellent oral and written communication skills
-Driven and self-motivated
-Detail oriented with the flexibility to evaluate the
need for detail against the overall project needs
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Director,
Maufacturing Technology
A pharmaceutical company located in Connecticut is seeking
a Director, Manufacturing Technology for the following
responsibilities:
- Responsible for the management of a multidisciplinary,
technology, functional group providing: leadership,
product development, technology transfer, technical
support and technical training to pharmaceutical scientists
in Technology and production associates.
- The group responsibilities include develop and advance
technologies associated with the registration and industrialization
of pharmaceutical drug products. Immediate objectives
of the department will be to develop and scale-up processes
for the manufacture of dry powder inhalation forms including
the advancement of the patented filling/packaging technology.
- Accountable for coordinating the efforts of process
associates and participating in project teams to develop
effective strategies to ensure timely completion and
implementation of projects to improve quality, ensure
customer service, and lower costs.
- Provide technical expertise to associates on theory
and practice of pharmaceutical formulations, processes,
cGMPs, FDA regulations, investigative techniques for
troubleshooting manufacturing problems to resolve problem
batches due to raw material quality, process deviations,
equipment problems, etc.
- You will be responsible for the performance evaluation,
staffing, salary recommendations and career development
of all individuals in the Process Department.
- You will represent the department to senior management,
outside companies and regulatory authorities.
- You will be expected to have a global perspective
for all Technology programs and set priorities accordingly,
based on overall company goals.
- You will manage and motivate a department of pharmaceutical
scientists to achieve site goals and objectives.
Requirements:
- Minimum of 15 years pharmaceutical experience and
7 years supervisory experience including formulation
design, process development scale up, technology transfer,
validation and manufacturing of pharmaceutical and nutritional
supplements.
- Minimum of a BS degree in a scientific field such
as Pharmacy, Chemical Engineering or Chemistry.
An MS in Industrial Pharmacy, Chemical Engineering or
Chemistry is preferred.
- Must have positive attitude
- Strong ability to work with others and become integrated
within the various teams within the company
- Experience with start-up operations
- Excellent writing and verbal skills, negotiation and
meeting facilitation skills, and strong organizational
and project management skills
- Knowledge of cGMPs and validation requirements.
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Senior
Upstream Biotech Process Engineer
Job Description:
As a member of the core team for Biologics Third Party
Manufacturing Strategy, the Sr. Process Engineer will
have scale up experience in both Upstream and Downstream
process, with expertise in Upstream. The Sr. Process
Engineer will be directly responsible for process fit,
technical transfer and validation of cell culture purification
processes to third party manufacturing and other internal
manufacturing facilities.
The Sr. Process Engineer will also be responsible for
the critical interfaces with Development, Analytical
Biochemistry, QA QC, Global Engineering and Manufacturing
Operations, including direction and training of others,
where applicable. Position will also be required to
prepare, produce and/or review critical regulatory documents
and other technical reports.
Job Requirements:
The successful candidate will have PhD in Biochemical
Engineering or related discipline and 3 to 5 years of
relevant industrial experience. Direct experience with
development and validation of protein therapeutic processes
and cGMP manufacturing experience are essential. Experience
in all aspects of technical transfer of processes between
facilities is required.
Strong experience and ability in Technical report writing
and review essential, as is critical reading of reports
and other regulatory documents. Strong business acumen,
proven organizational, multi tasking, time management
and writing and communication skills required. Proven
ability to balance business requirements and technical
work scope. Ability to work effectively as a member
of larger cross functional teams. Significant travel
required, up to 50 percent, both domestic and international.
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Senior
Downstream Biotech Process Engineer
Job Description:
As a member of the Core Team, the Sr. Process Engineer
will be knowledgeable in both Upstream and Downstream,
with Downstream expertise. The Sr. Process Engineer
will be directly responsible for process fit, technical
transfer and validation of cell culture purification
processes to third party manufacturing and other internal
manufacturing facilities.
The Sr. Process Engineer will also responsible for
the critical interfaces with Development, Analytical
Biochemistry, QA QC, Global Engineering and Manufacturing
Operations, including direction and training of others,
where applicable. Position will also be required to
prepare, produce and/or review critical regulatory documents
and other technical reports.
Job Requirements:
The successful candidate will have PhD in Biochemical
Engineering or related discipline and 3 to 5 years of
relevant industrial experience.
Direct experience with development and validation of
protein therapeutic processes and cGMP manufacturing
experience are essential. Experience in all aspects
of technical transfer of processes between facilities
is required. Significant travel required, up to 50 percent,
both domestic and international.
Strong experience and ability in Technical report writing
and review essential, as is critical reading of reports
and other regulatory documents. Strong business acumen,
proven organizational, multi tasking, time management
and writing and communication skills required. Proven
ability to balance business requirements and technical
work scope. Ability to work effectively as a member
of larger cross functional teams.
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Research Scientist, Process Development
Pharmaceutical company located in New York is seeking
a Research Scientist, Process Development. Responsibilities
will include:
Support research activities in the areas of drug product
process development, process optimization, scale-up,
and technology transfer.
Job responsibilities include designing, organizing and
executing independent projects to develop new products
as well as to improve existing processes.
Designing experimental protocols using statistical tools
to determine process response to controllable factors
and preparing technical reports, data summaries and
quantitative analysis, including cleaning validation
and regulatory documents
Prepare and review technical reports, monographs, status
of project reports with proper conclusions and recommendations
In addition, the candidate should have excellent oral/written
communication skills, strong interpersonal skills and
a people's person with leadership skill.
Traveling to manufacturing sites to support process
development cycle / technology transfer
Ideal candidate should have strong leadership and motivational
skills;
Methodical/Organized researcher with excellent verbal,
written and communication
skills; Understand FDA requirements in IND, NDA, PAI
and SUPAC guidance.
A Ph. D. in Pharmaceutics or Pharmaceutical Chemistry
with 0-3 plus years of experience OR , B.S., M.S. with
5-7 plus years of experience is required
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