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Senior Scientist, Drug/Biologics Product Development

📁
Research & Development
📅
200009ZG Requisition #
Careers that Change Lives

The Senior Scientist will be responsible for research & design of biocompatible coatings and/or formulations for drug/biologics delivery systems to support next generation sensor programs. This work will leverage existing and new technologies and the candidate must have extensive knowledge of current technologies used in implantable medical device coatings and drug delivery systems.  This position will also support product development activities including characterizing physiochemical properties of coatings & driving pre-clinical and clinical studies in preparation of IDE filings. The candidate should have strong analytical chemistry and communication skills as he/she will work closely with analytical chemists responsible for the technical aspects of developing analytical methods to gain understanding of key attributes in product and process. 

A Day in the Life

• Maintain a high level of expertise within the field and generate new technologies and concepts to be applied in the development of biocompatible coatings and/or controlled release drug products.
• Collaborate with appropriate functions and develop processing methods to produce intermediates, prototypes, and devices 
• Key liaison with CROs and internal service groups for Analytical method development, transfers, validation as well as planning of testing (Lot release, Stability testing etc)
• Analyze and critically evaluate analytical data to support method development, formulation development & product characterization
• Leverage design of experiments (DOE) to screen formulation designs; select appropriate analytical/material techniques to develop process-structure-property correlations and characterize product/process; utilize statistical process capability tools & regulatory guidelines to create analytical product specifications in support of IDE submissions. 
• Independently drive project planning & timelines, experimental design and study coordination with other technical groups (Analytical Sciences, process development, pre-clinical & clinical).
• Compile and analyze all datastreams and formulate relevant, scientifically based conclusions; conduct briefings with senior leaders within job function to communicate project updates.
• Organize data & create technical documentation in the form of specification documents, technical reports, presentations & operating procedures.
• Participate in cross-functional product development team as subject matter expert and provide technical support to manufacturing, analytical R&D, quality assurance, clinical, and regulatory affairs
• Write CMC sections to support IDE and PMA submissions for combination products
• Collaborate with and provide technical mentorship/directions to junior team members to ensure project deadlines and performance standards are met. Effectively delegate work as appropriate.
• Ensure compliance with current organization policies/procedures/SOPs, cGMP, GLP, ICH & FDA regulations and guidelines.
• Establish collaborations with internal and external partners
• Collaborate effectively with other scientists in a multidisciplinary team environment to research, identify & recommend emerging innovations/technology development efforts aligned with divisional needs and strategic vectors of the team, and submit idea disclosures.

Must Have: Minimum Requirements
Education Required
Bachelor’s Degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, Biochemistry, or related Sciences/Engineering discipline

Years of Experience
Bachelor’s Degree with a minimum of 4 years of relevant experience or an Advanced Degree with a minimum of 2 years of required experience

Nice to Have
• MS Degree
• Previous experience & knowledge of major analytical techniques such as HPLC, GC, LC/MS, etc
• Good understanding of controlled drug delivery systems  
• Medical device/biotechnology/pharmaceutical industry experience with an emphasis on combination device/drug product development 
• Knowledge in Analytical method development and validation as it relates to pharmaceuticals/biologics, and familiarity with lot release and stability testing
• Familiarity with chemical modification of surfaces such as small molecules/biomolecules immobilization, adhesion/bonding of surfaces etc
• Synthesis/development of functional polymer materials/oligomers & various polymerization techniques 
• Familiarity with a variety of polymer processing technologies such as coating, extrusion, and molding
• Knowledge of various chemical & physical coating application processes (spray, spin, dip etc)
• Familiarity with a variety of material characterization & Surface analysis techniques such as XPS, DSC, TGA, GPC, XRD, SIMS, FTIR, Raman, DMA, TMA, SEM, Optical Microscopy, etc
• Working knowledge of rheology and mechanical properties of polymers
• Good working knowledge of DOEs and statistical data analysis methods (T-test, ANOVA and significance testing etc)
• Understanding/experience in pre-clinical model development
• Good understanding of biochemistry, cell biology, pharmacology & pharmacokinetics 
• Excellent communication/presentation skills, solid writing skills & collaborative interpersonal skills.
• Highly detail-oriented, organized, self-driven showing initiative & ambition
• Results-oriented driver with hands-on, can-do mentality with the flexibility to adapt to changes quickly and ability to deliver in a fast-paced environment with challenging deadlines to help the company keep its leading edge.
• Excellent problems solving skills including ot-of-the-box thinking in finding solutions to unexpected challenges.


About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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