Jeffrey M Lawrence
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Production Supervisor
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Production Supervisor, Johnson Matthey Pharma Services, 02/14/00 –
Experience Present
Responsible for planning and all daily operations associated with our
Large-Scale Purification process. This includes setting the operator
schedule and any resolution that is required to the schedule.
Provide on the floor training to support formalized technical and GMP training.
Check that operator training files match and support the processes they are
required to carry out, and provide continued motivational and team building
atmosphere. Help management to provide a path for operators and school them
to advancement.
Purification of Pharmaceutical API’s by use of Large-Scale Purification
columns varying in size from 30cm to 100cm (I.D.).
Monitor operator training files and work with compliance specialist to keep
files up to date.
Review, on a shift wide basis, the batch records for error and deviations,
signing off responsibility to the next supervisor after this review.
Lead purification process and perform real-time analysis of the
operation while running. This would include making the decision on
fraction collection scheme based on in-line UV trace display and typical
subunit peak purity profile based off of research of previous campaigns if
available. Often it is necessary to change operating parameters, such as
flow rate or elution scheme, which I direct the team if required.
Assist in scale-up of all processes to maximize loading capacity and
yield capabilities in order accomplish the most efficient operation.
Packing and un-packing of columns used for purification prior to use for
processes or to ready columns for cleaning prior to new process.
Perform routine maintenance on column and all associated parts such
as seals, frits, valves and all other process dedicated equipment. This
includes pumps, flow-control meters and valves, UV flow cells and Thin-
Film Evaporators that are used in concentration of product that meets
target specifications.
Maintain and order all required components of purification columns. I
was able to find alternative suppliers for many of the O-rings, gaskets
and Teflon seals that are necessary for column production. By doing this
I was able to generate an annual savings of ~ $68,000 on frequently
replaced components for our 100cm Column. This savings will also be
able to be applied to our other columns going forward.
Order and maintain required solvents for production. This includes
receiving said solvents into our inventory system and dispensing out of
the inventory system once it is consumed.
Order replacement parts for process equipment from suppliers when
needed, or research to find a supplier for whatever parts are needed.
Purchase the required parts through the company purchasing system.
Write and revise documentation such as SOP’s as needed to ensure
cGMP manufacturing practices are being followed, or create an SOP if
the procedure is new or if a new piece of equipment is being
implemented to an operation.
Train all staff on operation and safety related SOP’s and
documentation, as well as perform refresher training on all
documentation as needed.
Revise or create Batch Records, which are the written procedures that
are followed during production.
Assist in validation\qualification of any new equipment that is to be
introduced to the process, and any new procedures that are developed.
Manage all troubleshooting on equipment and process while in
operation as well as during off hours.
Assist in yearly calibrations of process equipment.
Chem Design Corp. Fitchburg, Ma. 01420
Chemical Operator: 06/1992 02/2000
Manufacturing of custom and quality chemicals used in various
industries for many different applications.
Combining of various chemicals, both solvents and acids, in order to
achieve the desired fusion of chemical compounds and produce the
desired product.
Precise weighing and transferring of compounds into various sized
reactors that were either stainlesssteel or glasslined, depending on the
physical properties of the particular compound.
Once in the reactor it was my responsibility to perform extreme
exothermic or endothermic reactions by use of several different heating
and cooling methods, such as hot oil, steam and glycol cooling systems.
Perform general maintenance work on the process equipment.
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Member of the Emergency Response Team, as well as Asst. Lead
Operator.
Education:
Mount Wachusett Community College Gardner, Ma.
Years Attended 1990 1992
Associate Degree Criminal Justice
ERT Member, Fork truck Certified
Training &
Certificat
ions
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