Senior Pricing and Packaging Manager
Juniper SquareSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Sr Scientist - Steriles Packaging Development & Design (client dedicated) at Thermo Fisher Scientific
Ware, England, United Kingdom
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, BiopharmaceuticalIndustries
Requirements
- Graduate in Mechanical Engineering, Biomedical Engineering or related degree
- Experience of medical device or combination product development
- Understanding and experience of working within device regulatory requirements and industry processes such as design controls (21 CFR 820.30), EU MDR 2017/745, risk management (ISO 14971), QMS (ISO 13485) and GMP
- Experience in Design History File, Risk Management File, and design controls for combination product experience in the pharmaceutical industry
Responsibilities
- Support packaging and device development work streams for R&D integral drug device combination and/or co-packaged product development projects
- Management of Design History File (DHF) documentation
- Ownership of device work packages, co-ordinate testing activities (e.g. verification, validation, Design of Experiments, robustness studies) to ensure combination product safety and performance
- Author device development documentation including Design History Files (DHF) and Risk Management Files (RMF)
- Participate in packaging and device risk assessments (e.g. user, design or process risk assessments) as needed
- Participate in design reviews at critical stages of development as needed
- Supplementary activities to support specific projects as required
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the work arrangement for this role?
The role is based at the client’s site in Ware, Hertfordshire, UK and offers hybrid working.
What essential qualifications are required for this position?
Candidates need a graduate degree in Mechanical Engineering, Biomedical Engineering or related field, experience in medical device or combination product development, and understanding of device regulatory requirements including design controls (21 CFR 820.30), EU MDR 2017/745, ISO 14971, ISO 13485, and GMP.
What are the preferred experiences for this Sr Scientist role?
Preferred experience includes sterile drug primary packaging development for large and small molecules (vial/stopper, pre-filled syringes, cartridges), knowledge of device and packaging regulations (FDA/MAA guidelines, USP/Ph Eur, ISO), and familiarity with integral and non-integral parenteral packaging materials, components, vendors, analytical equipment, and technologies.
What is the salary or compensation for this position?
This information is not specified in the job description.
What makes a strong candidate for this Sr Scientist role?
A strong candidate will have essential experience in medical device development and regulatory processes, plus preferred expertise in sterile packaging for pharmaceuticals, including knowledge of materials, vendors, and relevant ISO/FDA standards.
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees