Director, Quality Assurance - GxP (GCP) Remote
Axsome Therapeutics IncSalary not specified
- Full Time
- Senior (5 to 8 years)
Thermo Fisher Scientific
MS&T Director – Aseptic Process Simulation / Smoke Studies
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
Candidates must possess an MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field, and have at least 10+ years of professional experience in GMP manufacturing relevant to the specialist area of expertise. They should demonstrate a strong understanding of Pharma, GMP, and Regulatory aspects, and be comfortable with up to 30-40% travel as needed.
Responsibilities
The MS&T Director will provide SME expertise in Aseptic Process Simulation and Smoke Studies for sterile pharmaceutical processes, establishing division strategy and updating global standards. They will ensure consistent application of APS and Smoke Studies approaches across sites, provide complete support on APS topics, assist in troubleshooting and root cause investigation, review and improve sterile site aseptic practices, collaborate with manufacturing teams on new technologies, monitor GMP, EU, and FDA regulatory changes, and support aseptic manufacturing projects. Furthermore, they will serve as the Network SME, define new technical standards, benchmark internally and externally, author GOPs, and drive opportunities for improvement in process efficiency and product quality.
Skills
Aseptic Process Simulation
Smoke Studies
Sterility Assurance
Process Characterization
Regulatory Compliance (GMP, EU, FDA)
Aseptic Manufacturing
Validation
Process Improvement
Training Development
Troubleshooting
Root Cause Analysis
Technology Implementation
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