Manager,
Recovery Sciences
A pharmaceutical company located in New York is seeking
a Manager, Recovery Sciences, who will provide in depth
scientific and technical knowledge, expertise and direction
to Biotechnology Development scientists in the Recovery
Sciences area. The successful candidate will conceive
innovative applications, technologies or sciences that
result in continuing improvement in Biotechnology Development
capabilities and in execution of development projects.
In addition, the Manager, Recovery Sciences, will demonstrate
a passion for excellence in execution of only the highest
quality science and technology, champion the Biotechnology
Development safety culture, and continuously acquire
new knowledge in the field of recovery sciences through
reading and participation in professional meetings.
Deals with complex scientific issues by pursuing critical
analysis and develops reasoned solutions. Thinks in
a clear, decisive manner, and reaches independent, reasoned
solutions. Facilitates open and successful communication
among scientists, both within Biotechnology Development
and also to a broader audience, particularly partners
in other Technical Operations departments. Effectively
communicates thoughts, ideas and results to a variety
of audiences. Is proficient at writing formal reports
and scientific articles for publication.
Requirements:
The successful candidate will have a Ph.D. or equivalent
experience in a relevant scientific discipline with
experience in recovery methods for biologic products.
Mastery of process research and development processes
with particular emphasis on development of practical,
efficient and scaleable biologic manufacturing processes.
Knowledge of the regulatory aspects of process research
and development is highly desirable.
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Director
of Manufacturing
A pharmaceutical company located in Northern New Jersey
is seeking a Director of Manufacturing for the following
responsibilities:
" Assure all drug products manufactured meet the
required specifications and physical aspects for strength,
quality, purity, efficacy based upon approved processes
and procedures.
" Ensures adequate daily, weekly, monthly and quarterly
production schedule reviews. Schedules manpower, materials
and production capacity based on production peaks and
fluxes.
" Assesses equipment and labor capacities for forecasted
production requirements. Assures adherence to standards,
monitors and analyzes ways to improve quality, delivery
and cost aspects of manufacturing.
" Coordinates in-plant support of new product development
and optimization projects to ensure timely preparations
and product launch. Reviews and optimizes batch records
and SOP's where possible to realize best practices and
effective shop floor performance.
" Direct activities consistent and in alignment
with current business needs of the company.
" Anticipate manufacturing and operational problems
and take steps to minimize their occurrence by making
managerial decisions based on sound judgment for the
interest of the company.
" Monitor performance and performance improvements
against plan. Communicate with all internal disciplines
as required. Report on all deviations and assure timely/comprehensive
completion of follow on plans
" Participate in the development and execution
of short and long range planning.
" Disseminate pertinent information down to the
shop floor keeping them up to date with changes in policy
and management philosophy that affect them directly
or indirectly.
" Performs other functions as dictated by the VP
Manufacturing and Operations or those deemed necessary
to achieve organizational objectives.
" Assures on time completion of assigned goals.
Education/Experience Requirements:
- B.S. degree in Science or Engineering with 7-10 years
progressive management experience in pharmaceutical
manufacturing. Masters degree preferred.
- Proficiency in areas of inventory control, planning,
scheduling, analysis, problem solving, process improvement,
mentoring and leadership.
- Superior communication skills and ability to manage
and influence cross-functional teams.
- Strong presentation skills are a must in addition
to demonstrated problem solving skills and strong analytical
thinking ability.
- Creativity, accuracy, judgment with timely execution
and ability to continuously monitor various assignments
and tasks to completion are required.
-Knowledge of Lean Manufacturing a +
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Director,
Commercial Manufacturing
A pharmaceutical company located in Connecticut is seeking
a Director of Pharmaceutical Manufacturing who will
be responsible for the manufacturing of drug products.
These responsibilities will span plant operations, manufacturing
development, supply of materials for pre-clinical and
clinical development and commercialization of the drug
product. The Director also ensures proper resources
are available (qualified people, materials, equipment,
facilities, processes) to meet current and future goals;
meets Manufacturing and Company goals and ensures an
uninterrupted supply of development and clinical product;
ensures systems are in place to successfully complete
regulatory inspections; and plans and manages to continuously
improve safety, quality, reliability, efficiency and
staff development.
Requirements:
MS in Chemical Engineering with 12 plus years related
experience; or PhD with 8 plus years experience and
5 plus years prior supervisory experience; high level
of competence in pharmaceutical development, technology
transfer and manufacturing support in pharmaceutical
industry, including knowledge of pharmaceutical quality
standards, validation guidelines and regulatory compliance
issues; extensive experience writing and implementing
SOP's in a GMP environment; experience with long term
planning and development of capital requests to support
manufacturing; experience developing and maintaining
budgets; and proven track record of developing, training
and mentoring subordinates.
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Manager Commercial
Manufacturing Purification
Biotech company located in New Jersey seeks a Manager
Commercial Manufacturing-Purification. This position
is responsible for the supervision of the purification
manufacturing operations for the commercial production
of the company's monoclonal antibody products. This
position will report to the Director of commercial manufacturing
and will interact with engineering, maintenance, validation,
quality assurance, quality control, clinical development
and logistics departments. As needed, further interaction
will be required with material vendors and commercial
partners. Knowledge of purification operations and support
systems, along with spreadsheets and databases is essential.
" Responsible for overall plant management of
purification operations and support services functions;
" Develops budget projections, material and staffing
forecasts.
" Develops production schedules to meet commercial
supply goals.
" Provides accurate production forecasting methods
with continuous improvement through capacity optimization
and cost reduction programs.
" Implements and maintains personnel policies,
procedures and production control systems.
" Ensures cGMP compliance, ensuring that all production
equipment is properly validated and production processes
meet quality standards.
" Measure and appraise subordinates' performance
against job duties and objectives. Provide accurate
feedback. Recommend/approve merit increases, promotions,
hires and terminations.
" Coordinates validation and start-up of BB50 facility
and any new/improved equipment.
Skills:
Has previously started up a purification facility; Has
a detailed process and equipment knowledge of purification
and support services functions; Has a thorough understanding
of GMP requirements for a commercial scale manufacturing
facility; Experience in successful facility licensure
a plus; Excellent communication skills, both oral and
written;
Demonstrated supervisory skills.
A BS/BA degree preferably in technical discipline or
equivalent experience is required.
Minimum of 10 years experience in a purification/biologics
facility with minimum 4 years supervisory experience
in a GMP production environment also required.
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