Michael Larcom Email & Phone Number

Brisbane, Queensland, Australia

Brisbane, Queensland, Australia

Melbourne, Australia

Brisbane, Australia

Brisbane, Australia

I am a Brisbane based consultant bridging the intersection of the the medical device, pharmaceutical and biotech sectors of the medical industry. I have vast experience in bringing various types of new products to market and also meeting the quality, safety and regulatory requirements of marketed products.

Brisbane, Australia

• At Factor Therapeutics we ran a well-executed double blinded placebo-controlled phase 2 clinical trial in the USA for a recombinant, chimeric protein, VF001 for treatment of venous leg ulcers. Being a small company, I.
• Updating the Quality Management System functionality for operational effectiveness and compliance to medical device and pharmaceutical requirements.
• Implementing an electronic QMS
• Executing QMS requirements and demonstrating that it was current and effective.
• Audit and approval of key global suppliers.
• Project Management - Drug Product technology transfer, stability and distribution of clinical lots.

Brisbane, Australia

Ability to lead and manage teams in multiple countries within Asia and Pacific region as the QA Director, APAC for Cook Medical, an innovative Medical Device manufacturing and distribution company.Contributed to the strategic direction of the multiple Cook organisation by participating in management meetings within Australia, Asia pacific and globally both.

Brisbane, Australia

Ability to successfully lead and manage the Quality Assurance function for the Australia manufacturing company, William Cook Aust Pty Ltd. This involved:Regular involvement in the strategic direction of global quality system development, through teleconferences and and face to face meetings of the global quality function.Liaise with and support other.

Brisbane, Australia

• Ability to successfully manage the Technical Services and QA/QC department of Sigma - Herron.At the time that I was at Sigma Pharmaceuticals it was the largest Australian owned pharmaceutical company. Significant.
• Involvement with the Site Upgrade Team and Continuous Improvement Steering Group.
• Active involvement in TGA inspections;
• Involvement and responsibility in other Internal/external audits;
• Monthly Management Review meetings; and
• Company representative on the Queensland Pharmaceutical and Neutraceutical Industry Forum.

Brisbane, Australia

• This role included,
• Supervision and guidance of Department.
• Setting and reviewing capital and operating budgets for the department.
• Liaising and working closely with other department heads through effective communication.
• Developed successful capital expenditure proposals for new and innovative equipment and technology. Projects include the application of NIR and production plant upgrades.Responsible for the development, management and.
• Developing and maintaining raw material supplier relationships.

Melbourne, Australia

• Arrow Pharmaceuticals was established in January 2000 as a new generic pharmaceutical company. The international R&D facility for the global Arrow group was located in Melbourne. Position: Formulation Development.
• Writing SOP’s to establish manufacturing practices in accordance with GMP.
• Writing SOP’s to establish laboratory practices in accordance with Good Laboratory Practice (GLP). Purchased, installed and commissioned numerous pieces of new equipment for the manufacturing plant. Examples equipment.
• Development of non-patent infringing processes where appropriate.
• Evaluation of active drug substance and size reduction (when required).
• Formulation development, manufacturing development and optimisation through batch trials.

Brisbane, Australia

• A thorough understanding of manufacturing processes used in solid dose preparations.
• Granulation,
• Drying
• Compression
• Coating
• Encapsulation A thorough understanding of GMP and its implementation in the production environment, this was demonstrated through:

Brisbane, Australia

Responsibilities and Achievements:Gained a thorough understand of GLP concepts and practice through compliance with laboratory procedures. Developed further my analytical techniques through the analysis of many samples, for example completing between 5-10 dissolutions on a weekly basis. This involved use of instrumental techniques such as HPLC, UV.