Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our team as a Manufacturing Sciences Scientist II, where you'll contribute to ensuring consistent production of therapeutic and diagnostic products. As part of our Manufacturing Sciences team, you'll work at the intersection of research and production, supporting process optimization, technology transfer, and continuous improvement initiatives. You'll collaborate with cross-functional teams to resolve technical challenges and ensure robust, scalable manufacturing processes that meet quality standards.
Day to day support and troubleshooting for the manufacturing department. This includes knowledge and thorough understanding of filter integrity testing, chemical weighing, formulation and the milling and blending processes.
Implementation of new products and processes. Continued support and update of these using the quality system and change control procedures. This includes modifications to the manufacturing system to allow for special customer requirements, writing individual product manufacturing instructions and SOPs and liaise with various departments to ensure correct implementation of new processes and changes to existing processes.
Changes to standard procedures to support continuous quality and efficiency improvements e.g. rearrangement of BOMs to reduce wastage and processing time or improvement of processes following quality issues.
Reviewing feasibility for customer requests and changes, including testing changes, temperature issues and corrections following quality issues.
Resolution of quality issues relating to product manufacture. This includes investigation of out of specification test results, customer complaints and audit findings. This also includes a proactive review of processes to error proof them and anticipate issues.
Drive continuous improvement initiatives using PPI methodology and other process excellence techniques.
Participate as a team member and lead if required complex multifunctional projects
Collaborate and share best practice and knowledge across functions and if required across sites.
Ability to write and perform validations of processes and equipment.
Work with other departments to develop and improve current process equipment and systems to deliver change and improve key metrics
REQUIREMENTS:
- Advanced Degree with no prior experience required, OR Bachelor's Degree plus some experience in GMP manufacturing, process development, or related technical role
- Preferred Fields of Study: Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Molecular Biology, or related scientific field
- Strong understanding of cGMP requirements, regulatory compliance, and quality systems
- Expertise in analytical techniques and laboratory instrumentation (HPLC, spectroscopy, etc.)
- Experience with process validation, technology transfer, and scale-up activities
- Proficiency in aseptic techniques and cleanroom operations
- Strong project management and documentation skills
- Excellent written and verbal communication abilities
- Ability to work independently and collaboratively in a dynamic environment
- Demonstrated problem-solving and troubleshooting capabilities
- Proficient with Microsoft Office Suite and relevant manufacturing/quality systems
- Experience with risk assessment and root cause analysis
- Ability to train and support team members
- May require occasional weekend/off-hours support (very rare)
- Must be able to wear required PPE and work in controlled environments
- Physical requirements include ability to lift up to 35 lbs and stand for extended periods
