Jeremiah Decosta
Vice President, Operations
Summary
Performance-driven Vice President with 15 years of experience aligning systems with business requirements, policies and regulatory requirements. Passionate about applying excellent organization and communication skills to manage and lead teams. Results-oriented individual well-versed in interfacing and consulting on business processes to drive results based on sound overall business judgment.
Forward-thinking and s dedicated to continuous business improvement focused on enhancing revenue and streamlining business operations. Diligent in driving profit maximization through multifaced business approaches.
Overview
17
17
years of professional experience
5
5
Certifications
Work History
Vice President, Operations
MiRXES Pte Ltd
1 2018 - Current
- P&L management enabling topline, profit margin and bottomline growth
- Assess, Strategize and Resource manage operational requirements for the business in the functions of Manufacturing operations, Clinical operations, Quality Assurance and Control, Logistics and warehousing, Procurement, Product Development and project management and Regulatory Affairs
- Managing a team of 7 direct reports and up to 50 indirect reports to ensure the following: 1
- Successful registration of medical devices via various regulatory pathways (HSA, FDA (US), CE IVDD/IVDR (Europe) and other required regulatory bodies that the business deems fit for expanding product lines into
- Sustainable P&L and General manager responsibilities for clinical operations offering various biochemistry and Lab Developed Molecular Tests
- A versatile QMS to support the scopes of LDT, DX and research use reagents production and clinical operations and inventory control activity
- Provide audit support for business units in a quality aspect and successfully pass all audits for Mirxes SG
- Set up and maintain validated and functioning manufacturing process for all MiRXES products and CDMO and clinical services
- Ensure Quality control on all product lines via validated QC methods with outputs such as Certificates of analysis and well documented QC reports for LDT, DX and research use reagents
- Support research and development activities at MIRXES Lab: a
- Support the purchasing, logistics and inventory management of research use reagents and consumables; b
- Support the production & QC of research use reagents for R&D purposes
- Logistics for materials purchasing and shipping to and from China
- Production of kits and components to support China's validation and LDT activitie
- Inventory maintenance and shipments across raw materials intermediates and Finished goods via:
- Inventory Control system and process that's compliant with Mirxes Quality management system
- Maintenance of shipping schedule
- Material Resource planning for all production activities and site to site transfer of materials
- Ensuring maintenance of the quality management system (QMS) within the Singapore site
- Independent review of all processes related to the design, manufacturing and quality of the company's medical devices and its components
- Communicate to senior management (CEOs) Office all quality related matters within the scope of 13485
- Hold management review meetings, at least once a year to review quality related processes (audit, QMS, design control, post market surveillance of medical device etc)
- Strategize on business continuity plans for the manufacturing plant to remain inline with over business strategy and goals a
- Ensure plant capability to perform day to day operational activities while building further capability and redundancy for expansion
- Collaborate both internally and externally on ensuring the manufacturing plants relevance locally and globally c
- Be part of a decision making team, as department head, to support fellow peers and managements' strategies and roadmaps leading to the success of MiRXES in its business activities.
Production Director
APTA Biosciences
11.2015 - 12.2017
- Set up and maintain manufacturing process for Seligo (Oligo and Amino Acid) and Seligo containing products that conform to ISO13485 and ISO 9001
- Set up of manufacturing, storage, shipping and dispatch of Seligo and libraries to customers
- In charge of team that manufactures internally produced materials and amidites for Seligo manufacturing
- Manufactured and delivered the highest quality libraries, seligo and products to customers
- Performed Technology transfer of all technology into Production and QC, keeping in consideration the company's quality management system and regulatory requirements
- Put in place and Quality Management system to lead the company to by ISO 9001: 13485 compliant
- Conduct audits on all processes in the company (not limited to manufacturing and QC) to ensure compliance to ISO, FDA, GMP and regulatory requirements
- Worked with External auditors and consultants in maintaining company's business and operational processes
- Developed a professional team to support the company's business interests
- Represent the Manufacturing group and their aims at a senior level within the company and also outside groups
- Act as an effective member of the company executive by formulating company strategy with relations to operations and manufacturing
- Represent the company at conferences both nationally and internationally
- Collate and deliver monthly reports for the manufacturing group and adhoc reports as requested
- Developed staff to improve and extend their performance to give them exposure to new areas of skills development
- Regular presentation to the board on strategies, plans and progress of the manufacturing and QC department
- Set individual and team objectives to hit Company level, team level and individual level KPIs
- Engage with consultants on topics of business and health care strategies for EU, US and SEA markets for diagnostics and health care products.
Production Manager/ Acting Head of Operations
Vela Diagnostics
09.2013 - 10.2015
- Nature of company- In-vitro diagnostics assay and extraction kits for the detection of various existing and new viral/Bacterial strains
- Reporting directly to the Chief Operations Officer, managing, developing and Growing a team of 22 people across different functions
- Direct Reports: 1)Manufacturing (Supervisor) 2)Technology Transfer (Technical Transfer Lead) 3) Material and Production Planning (Senior planner) 4)Process Engineering and Improvement (Senior Process Engineer)
- Manufacturing: Spearheaded operations start-up improvement in Vela Operations Singapore
- Oversaw a full production line of Bulk formulation, Dispensing and Kitting of Diagnostic Assay and Extraction kits ensuring compliance to Quality and regulatory standards (Processes, products, labeling, storage, environment)
- Environment control of production plant against product to product contamination, external molecular contamination and microbial contamination
- Worked cross functionally to solve Biochemistry and Molecular biology related functional QC failure
- Maintaining Records using Statistical process Control measures
- Acted as mentor and advisor for technical QC and QA issues
- Implemented lean six sigma methodology and Kaizen (5S) awareness across the production floor
- Set up and improved CAPA, NCR and ECO/DCO processes, making it concise and audit friendly
- Worked within a team to launch a quality portal for documentation of quality processes (NCR, DCO, ECO e.t.c.)
- Handled customer complaints when necessary and led investigation teams into root cause analysis
- Improved on ERP and Document control settings to provide straightforward downloads of batch records and Work instructions
- Ensuring safety is of top most priority while working in a BSL2 environment
- Budget costing and implementation for work year.
Chemist, Supervisor
Illumina, Inc, Department of Reagent and Formulation
01.2011 - 09.2013
- Seeing to the Formulation of Reagents and its components for Sequencing Technologies namely the Genome Analyser IIx, Infinium and Hi Seq Sequencing products
- Troubleshooting problems related to chemistry, biochemistry and molecular biology
- Planning and scheduling formulation schedules and seeing to availability of Raw materials which are essential for Formulation of reagents
- In Charge of transfer of Technology and Formulation related activities from San Diego, California to Singapore
- Physically trained in San Diego and trained fellow colleagues in new products which have been transferred to the Singapore site
- Reestablished laboratory from scratch in a new compound during site relocation
- Provide reports and updates on behalf of the team for formulation activities on a weekly basis
- Communicate effectively with counterparts in the US to improve on processes in Singapore
- Proofreading and editing on Work instructions, Batch Records and SOPs to promote cost and time saving for the department and the company as a whole
- Set up various systems including a Kanban for better workflow and tracking of raw materials / consumables
- Mentored, trained and supervised new colleagues and subordinates in the company
- Actively involved in implementing EHS activities in Singapore and promoting site alignment or copy exact policy with America
- Maintain ISO 9001, 13485 and GMP standards for the current site
- Auditing process and equipment in Singapore site.
LABORATORY OFFICER
Genome Institute of Singapore - Agency of Science, Technology and Research (A*STAR)
01.2008 - 12.2010
- Worked extensively with various technologies for Genetic Sequencing (SOLEXA, GS FLX, Sanger e.t.c.)
- Part of community sequencing facility that sequences samples from external sources and external researchers
- Trained in and worked with the GS FLX sequencing platform
- Performed experiments on Chromatin Immunoprecipitation and various molecular biology experiments
- Worked in the production and research line with Real-time PCR technologies
- Familiar with Mouse Embryonic Tissue cell culture
- Trained in and worked with SOLEXA- GA IIx/ Hi Seq sequencing platform
- Performed analysis for all generated libraries across all platforms.
Education
Masters in business administration -
Nanyang Technological University
Bachelor of Science in Biomedical Science - undefined
University of Bradford
Diploma in Biotechnology - undefined
Ngee Ann Polytechnic
Skills
Strategic planning and execution
Certification
ISO 13485 Certified Internal Auditor
Personal Information
- Date of Birth: 06/06/85
- Gender: Male
Languages
English
Bilingual or Proficient (C2)
Chinese (Mandarin)
Advanced (C1)
Chinese (Cantonese)
Advanced (C1)
Timeline
Production Director
APTA Biosciences
11.2015 - 12.2017
Production Manager/ Acting Head of Operations
Vela Diagnostics
09.2013 - 10.2015
Chemist, Supervisor
Illumina, Inc, Department of Reagent and Formulation
01.2011 - 09.2013
LABORATORY OFFICER
Genome Institute of Singapore - Agency of Science, Technology and Research (A*STAR)
01.2008 - 12.2010
Vice President, Operations
MiRXES Pte Ltd
1 2018 - Current
Masters in business administration -
Nanyang Technological University
Bachelor of Science in Biomedical Science - undefined
University of Bradford
Diploma in Biotechnology - undefined
Ngee Ann Polytechnic
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