Senior Scientist

Stevanato Group - Boston, MA

COMPANY BACKGROUND

Founded in 1949, Stevanato Group is committed to creating systems, processes and services that guarantee the integrity of parenteral medicines.

In Stevanato Group’s vision for the future, quality is a crucial dimension for the development of their SG4D approach: through the synergy of all 4 Divisions – Glass, Plastic, Engineering, Services – Stevanato has become a full solution provider, adopting a Total Quality Approach to design new solutions in line with the highest quality standards and providing systems that are safe to patients. This focus on quality and innovation allows Stevanato to stay aligned with their customers, respond to the need of continuous improvement, and being compliant to all regulations that are applicable, which establishes the organization as an industry leader and ideal partner for fully integrated solutions in terms of products, processes and services.

Vision & Values:

At the heart of the Stevanato Group’s vision is the desire to drive technological innovations that combine pharmaceutical glass products and processes into systems, which then guarantee the integrity of parenteral drugs in a way that is far superior to anything that has been achieved before.

Our vision is based on four fundamental values, each one closely connected to the other in order to guarantee harmonious interaction, resulting in a leadership position that is rooted in excellence:

  • Trust and respect everyone
  • Be accountable
  • Be ethical, always
  • Listen and communicate with transparency and honesty
  • Deliver results

The Role

The Senior Scientist will be responsible for organizing and collaborating with the Technical Leader in spearheading and setting up crucial projects and study targets, as well as providing accurate, quality project deliverables. This person will be the point of contact in managing technical communications with customers, while defining study / project feasibility, test plans and efforts, and resources within Stevanato Group. In addition, the Senior Scientist will coordinate and supervise the execution team, providing timing and deliverables, all while focused on schedule / timeline, budget, and quality commitments for the customer. There will be critical oversight of the data collection and interpretation, analysis, documentation, and reporting of results and the derivation of study conclusions.

This is a critical role within Stevanato, and will include, from start to finish, test / study management, control of results and deliverables, from conception and design to completion. The ideal candidate will be working with a multitude of laboratory equipment, techniques and methodologies, and should have a demonstrated understanding in past work experience.

Key Responsibilities:

 General

  • Collaborating with Technical Leader to set project/study targets and deliverables
  • Managing technical communication with customers (point of contact)
  • Scientific responsibilities for the study plan/ protocol design and approval
  • Defining study feasibility, test plan, efforts, resources
  • Execute research activities (including bench work) if needed
  • Coordinating and supervising execution team (timing and deliverables): establishes and ensures schedule, budget and quality commitments are met for the customer
  • Oversight of data collection, interpretation, analysis, documentation, and reporting of results and the derivation of study conclusions
  • Assuring compliance SOPs and local regulations, and CFR, ICH and GCP guidelines TBD
  • Design, develop, and implement new analytical methodologies
    • Design Experiment according to DoE
  • Simulation transportation testing
  • Stress/accelerated testing, stability testing, shelf-life studies
  • Supervising instruments maintenance and calibration
  • Experience handling hazardous materials

Container Closure Systems: chemical analysis & compatibility

  • Delamination propensity & glass corrosion investigation
  • Extractables & Leachable (inorganic and organic)
  • Elemental impurities according to ICHQ3D
  • Particles and particulate matter analysis (visible and sub-visible particle content characterization)
  • Surfaces characterization, compositional and elemental analysis
  • Contamination identification

QUALIFICATIONS / REQUIREMENTS

Education

  • BS/MS/PhD PhD in chemistry, pharmaceutical chemistry/science, biotechnology or equivalent.

Qualifications

  • Must be a US Citizen or Permanent Resident
  • At least 5 years of experience in pharma, medical device or packaging (R&D) industry
  • Established knowledge of E&L, protein formulation and biotherapeutics
  • Well-established knowledge of analytical laboratory equipment
  • Expert in particular analytical techniques/methodologies such as:
    • Physical and chemical separation techniques
    • Inorganic element analysis (ICP-OES, ICP-MS and IC)
    • Chromatography (GC-MS /HPLC-UV/MS etc.)
    • FT-IR, Raman and UV-vis spectroscopy
    • Microscopic and optical- based techniques (light microscopy, SEM, etc.)
    • forensic and failure/fractographic analysis
    • Visible and sub-visible particles analysis and characterization (Light Obscuration, Micro flow imaging etc.)
    • Container Closure Integrity testing (vacuum decay, gas tracers, mass extraction, compendial methods etc.)
    • Surface characterization techniques (SIMS, Laser Ablation ICP-MS, XRF, AFM, etc.)
    • Functionality/mechanical testing (preferred)
  • Strong background and hands-on experience in the field of method design, development and validation & transfer according to ISO 17025, materials and testing standards, ICH guidelines, cGMP, GLP and ISO 11040, ISO 11608, USP , USP .
  • Extensive experience in test method customization
  • Root cause analysis and troubleshooting skills
  • Software:knowledge of Minitab, Origin, Office
  • Six sigma and/or green belt certification (preferred)
  • Metrology and instrument calibration knowledge
  • Project management experience (preferred)
  • Experience handling hazardous materials

 

This role is not offering relocation assistance or Visa sponsorship at this time



Posted On: Thursday, June 18, 2020



Apply to this job
or