Todd Rutherford has over 20 years of experience in pharmaceutical research and development. He currently works as the Technical Services Manager at Alphapharm, where he leads a team that supports product registration, compliance, and technical issues. Previously, he held several roles at Alphapharm in analytical method development, product development support, and laboratory management. He has a PhD in Chemistry from James Cook University and has authored several publications in peer-reviewed journals.

1. CURRICULUM VITAE
Todd James Rutherford (PhD, C.Dec)
58 Colonsay Street
Middle Park
Brisbane, 4074
QLD
Home T: +61(7)33760824; E: shebtodd@bigpond.net.au
Work T: +61(7)30006142; E: todd.rutherford@alphapharm.com.au
Date of Birth: 16th October 1971
http://au.linkedin.com/in/toddjrutherford
Professional Experience
(Refer to attached pages for specific details regarding the positions outlined below)
Alphapharm – A Mylan Company (http://www.alphapharm.com.au)
 Technical Services Manager, March 2009 – present
 Assistant R&D Laboratory Manager (Product Development), 2006 – 2009
 R&D Laboratory Team Leader (Analytical Method Development), 2005
 R&D Manufacturing Team Leader, 2003 – 2004
 R&D Laboratory Team Leader (Analytical Method Validation), 2000 – 2003
 R&D Chemist (New Projects and Technical Services Teams), 1998 – 1999
James Cook University of North Queensland (http://www.jcu.edu.au)
 Senior Research Officer, Division of Chemistry and Chemical Engineering, Sept 1997 - 1998
 Research Project, Bilateral Exchange Program (University of North Carolina), Aug – Nov 1996
 Undergraduate Laboratory Supervisor (Chemistry), 1993 – 1997
Tertiary Education
MoreSteam UniversitySM
 Lean Methods Accelerator, Completed 28th May, 2011 (http://www.
moresteam.com/university/enroll/index.cfm?course=191)
National On-Site Training
 Diploma of Business Management, 2005 – 2007 (http://www.nost.edu.au)
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2. Bremer Institute of TAFE
 Certificate III in Spoken and Written English, 24th September 1999
James Cook University of North Queensland
 PhD (Chemistry), Conferred 4th Dec 1997, Pass with Distinction 18th Jun 1998
(Thesis Entitled – Stereochemistry in Mono- and Oligo-nuclear Assemblies Based on the
[Ru(α,α’diimine)3]2+ Chromophore)
 BSc Hons (Chemistry), Awarded Class I, 1993
(Thesis Entitled – Stereochemical Influences in Polypyridyl Complexes of Ruthenium)
 BSc (Major – Chemistry), 1989 – 1992
Secondary Education
Ignatius Park College, 1984 – 1998, Tertiary Entrance Score 920
Awards
NSCA 5 Star – Category 5 Representative, 2011
Exceptional Achiever, Alphapharm, May 2001
Commissioner for Declarations (#78336), QLD, Jan 1999
Writing-up Grant, James Cook University, 1997
First Year Chemistry Tutoring Prize, James Cook University, 1996
Australian Postgraduate Research Award, 1994 – 1997
Nevitt Honours Bursary, James Cook University (Department of Molecular Sciences), 1993
Publications/Conference Papers
Patents
 Publication Number WO/2008/095263, ‘A Dosage Form Containing Two or More Active
Pharmaceutical Ingredients in Different Forms’, Sandra Blundell, Panagiotis Keramidas, Brett
Mooney, Todd Rutherford, Publication Date 14/09/2008
Conference Papers
 Oral Presentation entitled ‘Updates to Drug Master Files, Certificates of Suitability,
Pharmacopeial Monographs and API Second Sourcing – An Alphapharm Approach’ – Merck
Generics R&D Meeting, Toronto (Canada), August 2008
 Oral Presentation entitled ‘Method Development at Alphapharm’ - Merck Generics R&D
Meeting, Gold Coast (Australia), November 2005
 Oral Presentation entitled ‘Stereochemical Control of a Chromophore-Quencher Triad and the
Influence on Intramolecular Electron Transfer’, Lecture 1, Queensland Inorganic Group –
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3. Regional Symposium, Rockhampton (Australia), July 1997
 Oral Presentation entitled ‘Stereochemical Considerations in Polymetallic Homo- and Hetero-
Nuclear Polypyridyl Complexes of Ruthenium(II) and Osmium(II) with Bridging Ligand
1,4,5,8,9,12-Hexaazatriphenylene (HAT)’, Abstract 5L21, 31st International Conference on
Coordination Chemistry, Vancouver (Canada), August 1996
 Poster Presentation entitled ‘Stereochemical Control of Donor and Acceptor Groups in a
Monomeric Chromophore-Quencher Complex of Ruthenium(II)’, Abstract P123/B, National
Conference of the Division of Inorganic Chemistry, R.A.C.I, Townsville (Australia), June 1996
 Post Presentation entitled ‘ Stereochemistry in Tris(bidentate)ruthenium(II) Complexes
containing Unsymmetrical Polypyridyl Ligands’, Abstract C71, National Conference of the
Division of Inorganic Chemistry, R.A.C.I, Perth, July 1994
Scientific Publications
 ‘Isolation of Enantiomers of a Range of Tris(bidentate)ruthenium(II) Species using
Chromatographic Resolution and Stereoretentive Synthetic Methods’, T.J. Rutherford, P.A.
Pellegrini, J. Aldrich-Wright, P.C. Junk and F.R. Keene, Eur. J. Inorg. Chem., 1998, 1677-1688
 ‘Stereoisomers in Heterometallic (Ru2OS) and Heteroleptic Homometallic (RuRu’Ru”)
Trinuclear Complexes Incorporating the Bridging Ligand HAT (1,4,5,8,9,12-
hexaazatriphenylene)’ T.J. Rutherford and R.R. Keene, J. Chem. Soc., Dalton Trans., 1998,
1155-1162
 ‘Mapping Electron Transfer Pathways in a Chromophore-Quencher Triad’, J.A. Treadway, P.
Chen, T.J. Rutherford, F.R. Keene, T.J. Meyer, J. Phys. Chem. A, 1997, 101, 6824-6826
 ‘Isolation of the Stereoisomers of [{Ru(bpy)2}2{OS(bpy)2}(µ-HAT)]6+ (HAT = 1,4,5,8,9,12-
hexaazatriphenylene; bpy = 2,2’-bipyridine)’, T.J. Rutherford and F.R. Keene, Inorg. Chem,
1997, 36, 3580-3581
 ‘Stereochemical Control of Donor and Acceptor Groups in a Monomeric Chromophore-
Quencher Complex of Ruthenium(II)’, T.J. Rutherford and F.R. Keene, Inorg. Chem., 1997, 36,
2872-2878
 ‘Stereoisomers of Mono-, Di- and Tri-Ruthenium(II) Complexes Containing the Bridging Ligand
1,4,5,8,9,12-Hexazatriphenylene (HAT), and Studies of their Photophysical and Redox
Properties’, T.J. Rutherford, O.V. Gijte, A. Kirsh-De Mesmaeker and F.R. Keene, Inorg. Chem.,
1997, 36, 4465-4474
 ‘Chiral [Ru(pp)2(CO)2]2+ Species (pp = Bidentate Polypyridyl Ligand) and their use in the
Stereochemical Synthesis of Ligand-Bridges Dinuclear Complexes’, T.J. Rutherford, M.Q.
Quagliotto and F.R. Keene, Inorg. Chem., 1995, 34, 3857-3858
 ‘Stereochemistry in Tris(bidentate)ruthenium(II) Complexes containing Unsymmetrical
Polypyridyl Ligands’, T.J. Rutherford, D.A. Reitsma and F.R. Keene, J. Chem.Soc., Dalton
Trans., 1994, 3659-3666
Professional Activities
Alphapharm
 National Safety Council of Australia (NSCA), Category 5 Representative, 2010 - present
 Laboratory Management Representative, Health and Safety Committee, 2009 – present
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4.  Member, Environmental Awareness Group, 2009 – 2010
 Chair, Beyond 2000 Committee, 2003
 R&D Representative, Affirmative Action and Equal Opportunity Committee, 1999 – 2001
James Cook University
 Postgraduate Representative, Safety and Equity Committee, School of Molecular Sciences,
1995 – 1997.
 Student Member of Royal Australian Chemical Institute, 1994 -1998
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5. Job Specific Functions
Technical Services Manager - Alphapharm
March 2012 - present: The Analytical Services team was restructured into the Quality Department
to join the Quality Technical Support team. The Analytical Services team was assigned additional
responsibilities including analytical method optimisation, analytical method transfer and significant
product investigations. The Technical Support team were responsible for laboratory equipment
calibration and maintenance, reference standard administration and management, IT support and
validation, new equipment validation, environmental testing and laboratory project work until June
2012 after which time the responsibilities focused on laboratory equipment calibration and
maintenance and support for new equipment validation.
February 2011 – February 2012: The Technical Services Department was comprised of the
Analytical Services team and the Process and Project Engineering teams. The analytical team was
responsible for providing analytical support for product transfers between Mylan sites and third
parties, product compliance, new product launches and product technical and legal issues. The
process engineering team was responsible for providing manufacturing and technical support for
product transfers between Mylan sites and third parties, new product launches, product quality
investigations, new manufacturing equipment, technologies and processes, equipment validation
and site projects. The project engineering was responsible for management of installation and
qualification of new plant equipment, modification of new/existing plant and equipment and
construction of build environment.
March 2009 - January 2011: The Technical Services Department was comprised of the Regulatory
Affairs and Analytical Services teams. These teams were responsible for supporting compliance of
registered products, completing registration of R&D legacy products, managing product change
control, facilitating the registration of additional sources of drug substances, excipients and
packaging materials, supporting new product applications and launches, and supporting analytical,
manufacturing and/or packaging transfers between Mylan sites.
The focus of my role includes the following main activities:
 Providing leadership and guidance for Technical Services staff (15-20 staff);
 Supporting the registration of post approval commitments to the relevant standard (viz. GMP,
TGA, FDA, MHRA, Medsafe, TPD, ICH, Pharmacopeial) within the appropriate time frame;
 Develop and maintain high performance regulatory, laboratory and engineering teams;
 Identify and drive cost saving initiates and ensure the department meets budget obligations;
 Maintain a safe working environment for all employees and visitors;
 Liaise with domestic and international affiliates and suppliers;
 Approve regulatory, laboratory and technical documents (e.g. product specifications, test
methods, analytical method validation protocols and reports, chemical risk assessments,
Standard Operating Procedures, investigation reports);
 Involvement in new product launch and product transfer projects;
 Provide technical and regulatory support to the Quality, Manufacturing and Legal departments;
 Engage in and provided advice during budgeting process (capital and operating); and
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6.  Staff management through Performance and Development Reviews (Software:
SuccessFactors), Leave and Entitlement Management (Software: Connx) and Time Sheets
(Software: Kronnos);
 Maintaining general laboratory operations (Consumable ordering and approval via SAP,
overseeing machine/equipment operation/calibration/maintenance, staff training, coordinating
the introduction of equipment upgrades and new technologies); and
 Involvement in Quality and GMP Audits (US FDA, TGA, third party companies).
Assistant R&D Laboratory Manager (Product Development) – Alphapharm
The R&D laboratory was responsible for providing analytical support to the manufacturing team
through the evaluation of trial, pilot and submission batches; evaluation of drug substance samples
to identify suitable supply for subsequent product development; generating the required
documentation (eg. drug substance/drug product/in-process specifications and test methods,
process and analytical validation protocols and reports, drug substance/ drug product CoA’s and
assay reports, product stability trend cards) for regulatory submissions to the relevant health
authorities.
The focus of my role included the following main activities:
 Responsibility for the Method Development, New Project and Post Approval Teams;
 Coordinate the evaluation of trial/development batches, transfer the outcomes with the R&D
manufacturing manager and R&D director and facilitate subsequent product development;
 Coordinate the development of analytical method used to evaluate the active pharmaceutical
ingredients, trial/pilot/submission batches manufactured at Alphapharm and market leader
batches;
 Coordinate the evaluation and implementation of alternate sources of active pharmaceutical
ingredients;
 Manage the analytical support to meet post approval commitments;
 Identify and facilitate the introduction of new technologies to aid product develop;
 Promote health and safety in the laboratory;
 Aid in analytical problem solving for the R&D and Quality laboratories; and
 Initiating or facilitating strategies to improve efficiency in the laboratory.
Team Leader (Method Development), R&D Department - Alphapharm
This group is responsible for the development of the analytical methods (Identification, Potency,
Purity and Residual Solvent Methods) used by the R&D laboratory and also evaluation of
alternative sources of active pharmaceutical ingredients (API’s).
The focus of my role included the following main activities:
• Ensuring that rugged and robust analytical methods are developed to set timeframes;
• Writing or checking test methods which are developed in-house or based on the relevant
monographed test method;
• Evaluation of alternative sources of API and communicating the results and recommendations
to both internal and external customers;
• Problem solving for previously developed analytical methods and/or formulation development;
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7. • Assay Validation arising from the registration of alternative sources of API’s;
• Development of the Method Development staff and facilitating a productive, efficient and
enjoyable team environment.
Familiarity with Equipment/Processes:
• Isocratic and gradient Waters and HP HPLC systems with UV and PDA detectors - Millennium
and Dry Lab Software;
• Mastersizer S and Mastersizer 2000 Laser Particle Sizer
• Direct Injection and Head Space GC systems with FID detector – Turbochrom Software;
• IR and UV spectroscopy and TLC;
• Non-automated and automated Dissolution Machines;
• General wet chemical techniques;
• General computer skills – Word, Excel, Access, Outlook, Lotus Notes, Power-Point, MS
Project.
Team Leader (Manufacturing), R&D Department - Alphapharm
This group is responsible for the formulation development and manufacture of small and pilot scale
pharmaceutical products (patent expired, solid dose) and the technical transfer of the developed
product to commercial scale production.
The focus of my role included the following main activities:
• Involvement in the initial formulation development and any modifications necessary throughout
the development cycle;
• Planning and organising the team to ensure the assigned projects are completed within the set
timeframes to a high standard of Good Manufacturing Practice (GMP);
• Writing or checking Batch Manufacturing Documents for development and pilot scale batches;
• When appropriate, hands-on involvement in all stages of the manufacturing process;
• Technical transfer of developed products to the production department for initial commercial
scale manufacture;
• Writing Development Pharmaceutical Reports (DPR’s) - these reports detail the initial
formulation and method of manufacture through to the final optimised formulation and method
of manufacture, critical analytical results influencing the development process and robustness
studies.
Familiarity with Equipment/Processes:
• Dry Granulation / Wet Granulation (High Shear) / Spray(Fluid Bed) Granulation
• Drying (Aeromatic FBD), Crushing (Comil), Blending (v-blender and IBC)
• Pellet Technology (10 L Aeromatic Strea-1 FBP)
• Compression (D3 Press) / Encapsulation (AZ 20) / Exposure to a variety of high speed
compression equipment
• Tablet Coating (O’ Hara)
• General equipment for physical testing of inprocess and finished products
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8. • General computer skills – Word, Excel, Access, Outlook, Lotus notes, Power-Point, Glovia, MS
Project
Team Leader (Assay Validation), R&D Department - Alphapharm
This group is responsible for the validation of the analytical methods (Identification, Potency, Purity,
Dissolution and Residual Solvent Methods) used by the R&D/QA/QC laboratories and also
cleaning validation studies.
The focus of my role was comprised of the following main activities:
• Writing or checking assay and cleaning validation protocol’s, workbooks and reports;
• Planning and organising the team to ensure the assigned projects are completed within the set
timeframes to a high standard of Good Laboratory Practice (GLP);
• When appropriate, hands-on involvement in all stages of the validation studies;
• Checking calibration testing of all laboratory equipment;
Familiarity with Equipment/Processes:
• As above for Method Development
Chemist, Technical Services Group (Method Development), R&D Department - Alphapharm
This group is responsible for the development of raw material and finished product test methods.
These methods may be derived from the supplier or a pharmacopoeial (USP, BP or EP) method or
developed completely in-house. Industry guidelines issued by ICH, TGA, USP, EP etc. are also
considered during the development process. This group is also responsible for general analytical
problem solving and the validation of new technologies.
Chemist, New Projects Group, R&D Department
This group is responsible for the analysis and release of all raw materials used for development
and pilot scale batches and the resultant manufactured products. This group is also responsible
for process validation studies of the pilot scale batches.
PhD Project and Senior Research Chemist - James Cook University
The broad area of research for my PhD involved the utilisation of organometallic complexes (e.g.
[Ru(bpy)3]2+ ) in photochemical conversion processes. These transition metal complexes show
potential as the chromophoric component in chemical systems aimed at the conversion of sunlight
to high energy fuels (solar energy conversion).
The emphasis of my research focused on the stereochemical control of a variety of mono-, di- and
tri-nuclear complexes based on the [Ru(bpy)3]2+ or [Os(bpy)3]2+ chromophore. The various
stereoisomeric forms were generally isolated by a combination of stereoselective syntheses and
chromatographic techniques. The characterisation of these complexes and particularly the
isomeric forms were achieved by NMR, CD, UV/VIS, Emission and IR spectroscopy and the know
stereochemical consequences of certain chemical reactions.
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9. The stereochemical influences on photoinduced intramolecular electron transfer was investigated
by electrochemistry, transient absorbance spectroscopy and various luminescence measurements
at room temperature and 80K.
Results derived from my studies were the first reported examples that inherent sterochemical
differences in organometallic complexes of this type significantly influences various intramolecular
photophysical properties.
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