{"id":2043,"date":"2024-01-19T09:54:22","date_gmt":"2024-01-19T09:54:22","guid":{"rendered":"https:\/\/www.sedapds.com\/?p=2043"},"modified":"2024-01-19T11:28:56","modified_gmt":"2024-01-19T11:28:56","slug":"introducing-the-clinical-manufacturing-division-leadership-team","status":"publish","type":"post","link":"https:\/\/www.sedapds.com\/news\/introducing-the-clinical-manufacturing-division-leadership-team\/","title":{"rendered":"Introducing the Clinical Manufacturing Division Leadership Team"},"content":{"rendered":"

Following the recent announcement of Seda\u2019s expansion in to GMP manufacturing<\/a> we are pleased to introduce our new Leadership Team for Clinical Manufacturing. Welcome and congratulations to Effi, Darren, Mike, Vijay and Faye.<\/p>\n

Dr Paul Stott, CEO, commented \u201cI am delighted with the calibre of the team we have assembled. They bring the ideal combination of extensive experience and a modern, dynamic approach to quality operations. Together, I am certain that we will create a differentiated offering to the benefit of our clients and patients and a great working environment for our colleagues.\u201d<\/p><\/blockquote>\n

\u00a0<\/span><\/span>Meet the individuals and learn more about their roles below.<\/p>\n

Effi Baetzner<\/h2>\n\"\"\n

As the Director of Quality Control, Effi<\/a> will lead the strategic direction and operational aspects of Quality Control within the division. She will oversee the establishment and enhancement of quality control processes, ensuring the highest standards are maintained in the pharmaceutical manufacturing operations. Her responsibilities include providing leadership to the QC team, implementing effective quality assurance measures, and contributing to the overall success of the company. Dedicated to upholding comprehensive quality control standards to meet client expectations and regulatory requirements, she will be fostering a culture of excellence and continuous improvement.<\/p>\n

In her prior role at a distinguished <\/span>GxP<\/span>-accredited CRO, Effi <\/span>emerged<\/span> as a leader in analytical testing, specializing in Oligonucleotides and RNA for both commercial and developmental Drug Substance and Product. Drawing on her background as a studied organic chemist, she <\/span>possesses<\/span> a wealth of knowledge in small molecules and their comprehensive analysis, cultivated over years of focused <\/span>expertise<\/span>. Effi\u2019s multifaceted experience uniquely positions her to understand and address the diverse needs of Seda. As she journeyed from an R&D environment during her studies and PhD to a <\/span>GxP<\/span> environment, the understanding and implementation of <\/span>good quality<\/span> control processes increased throughout her career and brought her to this exciting opportunity<\/span><\/p>\n

Darren Gill<\/h2>\n\"\"\n

In his role as Director, Facility Management, Darren<\/a> will be responsible for the design, construction, installation and validation activities for the new GMP manufacturing facility, services and processing equipment. His role will entail ensuring that all regulatory and compliance requirements are met to the highest standards and subsequently managing the ongoing maintenance and compliance requirements, to allow the manufacture of high quality products.<\/p>\n

Prior to joining Seda, Darren worked in the pharmaceutical industry for 26 Years with involvement in R&D Projects across a wide range of Therapeutic areas and in Sterile Manufacturing, Solid Oral Dosage Forms and in Active Pharmaceutical Ingredients (API). Darren has many years’ experience in managing Facilities teams, upgrading existing facilities, introducing new equipment, new technologies and services (<\/span>eg<\/span> purified water systems, HVAC Systems) as well as System ownership for a number of GMP IT systems.<\/span>\u00a0In the last 2 years before joining Seda he worked within the Development Quality function responsible for the Quality Management System (QMS) and GMP Training.<\/span><\/span>\u00a0<\/span><\/p>\n

Mike Hingley<\/h2>\n\"\"\n

In his role as Director, GMP Operations, Mike<\/a> will be providing senior management oversight to the implementation and growth of the GMP operations capability across the division. Ensuring all client requirements are met through the manufacture and supply of high quality, GMP compliant products.<\/p>\n

Mike has over 15 years\u2019 experience in respiratory drug delivery and diagnostic manufacturing. Prior to working with Seda, Mike was based in Boston, MA as VP Device Manufacturing Operations at Sense <\/span>Biodetection<\/span> with responsibility for contract manufacture, and distribution of all North American and European diagnostic products<\/span>.\u00a0 <\/span>Before joining Sense, Mike held the role of Director of NPI and GMP Manufacture with Vectura Ltd, with responsibility for the manufacture and supply of pilot and clinical scale dry powder inhaler and <\/span>nebuliser<\/span> drug delivery systems.<\/span><\/span>\u00a0<\/span><\/p>\n

Vijay Masaun<\/h2>\n\"\"\n

As the Director of Quality Assurance, Vijay<\/a> will play a pivotal role in ensuring high standards of GMP across the division. With an eye for detail, a good knowledge of current regulatory guidance and a commitment to continuous improvement, Vijay will help spearhead initiatives that drive the quality assurance and compliance processes within the GMP facility from conception to execution.\u00a0 His strategic vision encompasses the implementation of robust quality management systems and fostering a quality culture. By collaborating closely with cross-functional teams, he will be able to identify potential areas for enhancement but also implement proactive measures to elevate products and the services provided by Seda. As a leader, he inspires and empowers to embrace a relentless pursuit of quality, underlining Seda’s commitment to delivering exceptional value to our customers.<\/p>\n

Vijay is an experienced Quality Professional with a distinguished career marked by several senior quality roles within various pharmaceutical <\/span>organisations<\/span> primarily in the CDMO\/CMO space.<\/span> His comprehensive understanding of the pharmaceutical landscape, coupled with his strategic thinking, has enabled him to navigate the complexities of the evolving industry standards.<\/span> Vijay has a proven <\/span>track record<\/span> spanning over 9 years in the pharmaceutical industry as well as training to be a Qualified Person (QP), which will bring valuable experience to the Seda GMP team and ensuring a commitment to upholding regulatory standards.<\/span><\/span>\u00a0<\/span><\/p>\n

Faye Briffa<\/h2>\n\"\"\n

Faye<\/a> is responsible for recruiting the best talent and developing and implementing HR policies across the Clinical Manufacturing Division.<\/span><\/p>\n

After a <\/span>20 year<\/span> career in HR working primarily in the Pharmaceutical Industry, Faye Briffa set up Ashfield HR, an HR Consultancy supporting <\/span>North West<\/span> based small and medium sized companies who have no in-house HR capability. Faye is CIPD qualified having achieved a Post Graduate Diploma in HR Management from Manchester Metropolitan University in 2002. Since then, she has held a variety of HR roles, <\/span>including in<\/span> Recruitment, Employment, Business Change and HR Business Partnering.<\/span><\/span>\u00a0<\/span><\/p>\n

The next step will be to seek out the very best talent to build out our Quality Control, Facilities Management, GMP Operations and Quality Assurance teams. Follow this link to see current opportunities<\/a>.<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Following the recent announcement of Seda\u2019s expansion in to GMP manufacturing we are pleased to introduce our new Leadership Team for Clinical Manufacturing. Welcome and congratulations to Effi, Darren, Mike, Vijay and Faye. Dr Paul Stott, CEO, commented \u201cI am delighted with the calibre of the team we have assembled. They bring the ideal combination…<\/p>\n","protected":false},"author":2,"featured_media":2069,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mi_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[1],"tags":[],"yoast_head":"\n\n\n\n\n\n\n\n\n\n\n\n\n\t\n\t\n\n\n\n\n\t\n