Director CMC Operations
Abarca HealthSalary not specified
- Full Time
- Senior (5 to 8 years)
Thermo Fisher Scientific
MS&T Director - Sterile Technical SME (Isolators - VHP)
Not SpecifiedCompensation
Junior (1 to 2 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, and possess at least 10 years of professional experience in GMP manufacturing relevant to the specialist area of expertise. They should demonstrate a strong process understanding encompassing Pharma, GMP, and regulatory aspects, along with the ability to confidently communicate both verbally and in writing and influence others to build cross-functional teams.
Responsibilities
The MS&T Director will provide SME expertise in Isolator Technology for pharmaceutical processes, establishing division strategy, developing global standards, and driving harmonization within DPD sterile sites. They will offer expertise on topics like Decontamination Cycles, Environmental Monitoring, and Cycle Development, support sites in troubleshooting, review sterile site aseptic practices, and collaborate with manufacturing teams to implement new technologies. Furthermore, they will monitor GMP, EU, and FDA regulatory changes, provide expert technical support in aseptic manufacturing, and steward the Aseptic Network, author GOPs, and facilitate IQ, OQ, and PQ qualifications.
Skills
Isolator Technology
Aseptic Pharmaceutical Processes
Decontamination Cycles
Environmental Monitoring
Cycle Development
Troubleshooting
Root Cause Analysis
GMP
EU Regulations
FDA Regulations
Validation
Sterilization
IQ/OQ/PQ Equipment Qualification
Technical Standards Development
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