Director, Global Medical Services Operations (East Coast Based Positio…
Axsome Therapeutics IncSalary not specified
- Full Time
- Senior (5 to 8 years)
Thermo Fisher Scientific
MS&T Director – Sterile Technical SME (Visual Inspection)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical ManufacturingIndustries
Requirements
Candidates must hold a Master's degree or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field. They should possess significant career experience in GMP manufacturing relevant to the specialist area of expertise, including validated process understanding with a focus on Pharma, GMP, and regulatory aspects. Up to 30-40% travel may be required, and strong communication skills, both verbal and written, are essential, along with the ability to influence others and build cross-functional teams while setting clear business objectives.
Responsibilities
As the MS&T Director – Sterile Technical SME (Visual Inspection), the individual will offer expertise in visual inspection for pharmaceutical processes, contribute to strategy creation and global standards, and ensure consistency across DPD sterile sites. They will provide significant knowledge of VI technologies/equipment and Leak Detection systems, including AI application to AVI, perform process characterization, assist in troubleshooting, monitor regulatory changes, support projects in aseptic manufacturing and lyophilization, and provide training and education. Furthermore, the role involves serving as the Network SME, collaborating with MSAT networks to establish technical standards, author GOPs, and support new product launches.
Skills
Visual Inspection
Aseptic Manufacturing
Sterile Processes
Leak Detection Systems
AI Applications in AVI
Process Characterization
Troubleshooting
Regulatory Compliance (GMP, EU, FDA)
Validation (IQ, OQ, PQ)
Lyophilization Technology
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.
Key Metrics
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees