NPD Scientist – Woundcare
Who are Advanced Medical Solutions?
AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com
AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.
Job details
Responsible for support to the Woundcare category. Work with the Commercial Team to exploit business opportunities and products for new and existing customers.
What the role involves:
* Identify and develop innovative intermediate and finished product developments (NPD), generating supportive documentation in accordance to AMS procedures, GLP, GDP and applicable regulations.
* Work with the Commercial Team and colleagues from other departments to assess viability of new opportunities and contribute to the development of Business Cases.
* Build relationships and technical knowledge with existing and new suppliers.
* Be technical point of contact for customers and new business potentials.
* To project manage AMS Stafford intermediate NPD business opportunities.
* To partake in Winsford NPD projects as the R&D stakeholder contributing towards the satisfactory progression in accordance to the applicable processes.
* In consultation, develop prototypes in line with customer insights/ requirements presenting ideas & concepts to internal & external clients.
* Develop and validates methods for manufacture and characterisation of new product developments (NPDs).
* Author and distribute technical protocols and reports correlating findings with data from literature where applicable. Planning of Sample testing and sample creation.
* Applies statistical methods for evaluation.
* Planning of pilot line and mainline trials including responsibilities and materials.
* Define new product construction and develop new product concepts with the potential to deliver growth.
* Design stability studies to support shelf-life determination for Products and Intermediates.
* Technical KPI monitoring and reporting.
* Participates in risk evaluations, using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA) associated with the PDP process.
* BS Degree or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 3 year experience in a similar role within medical device or pharmaceutical industries.
What we’re looking for:
* BS Degree or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 3 year experience in a similar role within medical device or pharmaceutical industries.
* Must be proficient in the knowledge of applicable Quality System Regulations and ISO requirements.
* Must have knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
* Proficient in concepts of statistics, sampling plans and statistical analysis.
* Proficient in analytical methods, equipment, process, software, cleaning and/or facility/utility validations.
* Ability to independently plan, execute, and/or problem solve moderate to complex situations.
* Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
* Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, medical personnel etc. across and outside of the organisation.
* Ability to manage multiple projects.
* Innovative mindset with knowledge and/or experience of New Product Development.
* Computer literate - knowledge of Word, proficient in the use of PowerPoint and Excel an advantage - in order to produce reports, analyse data etc.
Other
It is anticipated that this role would require approximately 50% of time based on site with 50% remote (home or other locations).