Wyeth
West Chester
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JOB
DESCRIPTION WORKSHEET - EXEMPT
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INCUMBENT'S
NAME(S)
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JOB TITLE
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Scientist
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ORGANIZATIONAL
UNIT
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SUPERVISOR'S
NAME
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SUPERVISOR'S
TITLE
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Technical
Services
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Director
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I.
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JOB
SUMMARY - Summarize the primary
purpose of the job in 2 to 3 sentences.
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This
position is primarily responsible for participating in the design and
implementation of projects which support the manufacturing operation. This
job is part of Technical Services. Technical Services provides overall
knowledge of the operation as well as the problem-solving expertise for
development, maintenance of products, and the validation of operation.
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II.
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JOB RESPONSIBILITIES
- List primary responsibilities which are part of the
job in order of importance.
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Percentage of time
spent on each duty
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1.
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Develops
protocols and implements process validation for the manufacturing
operation.
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10%
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2.
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Writes
technical reports in support of production operations including GTR's, NDA
updates, batch record revisions, and the development of original and
revised RPS's.
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35%
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3.
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Develops and
implements cleaning validation programs for the manufacturing operation.
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5%
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4.
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Develops and
implements sterilization validation programs for the facility.
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15%
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5.
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Troubleshoots
production problems for bulk products and final dosage forms.
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10%
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6.
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Designs and
implements programs for the validation or qualification of
new/transfer/third party products, alternate raw materials, new or revised
manufacturing processes, new/revised components, improvements to the Tubex®
package, and for new or modified manufacturing equipment and materials for
the manufacturing operation.
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20%
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7.
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Participates
on continuous improvement and Task Force teams in support of manufacturing.
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5%
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Total
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100%
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III.
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WORK
FLOW
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Describe
how the incumbent gets the work, the processes (mental/physical) which the
incumbent performs to transform the work, the work output, and what happens
to the work once the incumbent has finished.
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Receives
project assignments through the Manager, or as delegated through the
Technical Specialists/Experts or Operations Coordinator. The Scientist
prepares a formal protocol, with minimal assistance from the Technical
Specialists/Experts as needed, describing purpose, experimental design and
procedures to obtain results and
form conclusions. Keeps management, Operations Coordinator, and Technical
Specialists/Experts informed of Project progress, milestones, problems, and
when assignments have been completed. When a project has been completed, a
General Technical Report is prepared with minimal assistance, and approved
by the Technical Specialists/Experts and Technical Services management.
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IV.
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DECISION
MAKING
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A.
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Describe
the decisions generally made and indicate whether the incumbent is the
final authority or participates in the decision.
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1. Interprets
results and informs Technical Specialists/Experts and Operations
Coordinator as needed; participates in decision-making and provides
recommendations.
2. Project
design and implementation (with minimal assistance), management of projects
as well as data generation and analysis represent incumbent's
decision-making.
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B.
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Describe
the effect the decisions can have on company programs, processes, services,
customers or financial results.
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Decisions
are made in order to keep assigned tasks such as project and validation
programs on schedule. Regulatory compliance issues are considered, with
minimal assistance, in order to reduce the possibility of regulatory
action. Decisions are made with minimal assistance during projects to
improve quality, limit risk of batch failures, and save money where
possible. Flawed decision-making, incorrect interpretation of data, and
erroneous conclusions and recommendations may result in serious project
delays and the potential to require additional resources.
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C.
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Outline
the guidelines, practices, or limits which are used in making decisions and
which assist in recognizing limits of authority.
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Uses at
guidelines such items as project schedules, commitments to Form #5785
requests (Request for New or Revised Product Specifications), the current
validation plan, and other schedules developed in conjunction with
management; also, cGMP section of CFR, internal quality standards, and
SOP's.
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V.
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SUPERVISION
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Describe
the supervision that this position receives. In what manner and how often are instructions given? How and with what frequency is the work
reviewed?
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This
position receives broad, conceptual direction to projects through both
written instructions and verbal consultation, as necessary, through the
Technical Specialists/Experts, Operations Coordinator, Manager. The
incumbent determines the approach to resolve problems and handle projects;
performance is measured on completion of assignments.
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VI.
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BUDGET/ASSET
RESPONSIBILITY
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A. Describe
the duties that relate to budget preparation.
Provides
information, support, etc.
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B. What
is the value of the budget or assets administered in terms of $ or units,
or end results?
N/A
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VII.
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INTERPERSONAL
CONTACTS
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Type
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Reason
for Contact
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Frequency
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Internal
(Within AHP)
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Tech Servs
Mgmt
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Consultation
& Instructions
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Daily
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Tech Servs
Staff
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Consultation
& Directions
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Daily
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QA
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Info
exchange between departments
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Weekly
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Manuf.
Servs.
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As above
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Weekly
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Other TS R
& D depts
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As above
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Weekly
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External
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Raw
Material/ /equip vendors
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Gain info
related to products
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Weekly
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Misc. (other
co's, consultants, FDA, etc.)
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As above
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Weekly
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VIII.
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INGENUITY
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Describe
typical job situ ations that require creativity and innovation.
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This job
requires the implementation of complicated and lengthy projects, including
validation and product development-type projects. These projects require a
broad-based knowledge of parenteral products and aseptic techniques and
related disciplines. The incumbent is required to develop thorough and
practical solutions to a variety of difficult problems. Project assignments
are completed with minimal assistance from Specialists/Experts and Manager.
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IX.
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PLANNING
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What is the involvement with short and long range
planning?
What organizational units does
the incumbent plan for?
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Short-term:
Duties of the Technical Services laboratory which support the plant's
operations and validation plan. Long-term: Develops plans and participates
in decision-making processes for new and upgraded equipment for the
Technical Services' laboratory as well as for the operations at the plant.
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X.
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TRAINING
AND EXPERIENCE
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1.
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What formal education is required to perform the
job duties
(Degree, field)?
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Minimum
BS/BA in the Sciences or Engineering.
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2.
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What
training is required?
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Basic
knowledge of cGMP's, aseptic techniques, and pharmaceutical processing
equipment preferred.
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3.
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What
previous experience, skills and abilities are required to perform the job?
Where would it be obtained? What is the minimum number of years of
experience that are needed?
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4 - 6 years
relevant experience (BS/BA degree)
Minimum 3
years relevant experience (MS degree)
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XI.
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Total
number supervised
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0
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#exempt
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0
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nonexempt
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0
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Number supervised directly 0
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XII.
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ORGANIZATIONAL
CHART
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Please
attach an organizational chart which shows how the job fits into the
organization, including other jobs reporting to the same supervisor and all
positions reporting to the incumbent.
Indicate positions by titles and names of the incumbents; for
multiple incumbent jobs, the number of people may be shown in parenthesis
instead.
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