Analytical R&D Scientist/Senior Scientist

Exciting
#Opportunity
for
#AnalyticalResearch
Professionals at
#Intech
Biopharm (
#TAIWAN
)

If you are passionate about Creating, Sustaining and Working Together in Analytical Research and Development Culture in a
#Pharmaceutical
manufacturing site and meet the following requirements, then feel free to send across your updated resume along with a short summary of your accomplishments to

.

Responsibilities

• Support for analytical method development and R&D batches stability for drug formulations for Global Regulated markets (pMDI , Nasal Spray, DPI etc.)
• Perform analytical method development with AQbD, formulation screening, finished product testing, stability study, compatibility studies, RLD reverse engineering, technical transfer, and laboratory-related work during the development stage.
• Support ANDA submission and complete drug development lifecycle management. Knowledge about analytical methods for pMDI, DPI and nasal spray for US and EU markets. He should be well versed with techniques as, HPLC, Next generation impactor, DUSA, APSD, Plume geometry, breathing simulators, Malvern Mastersizer, MDRS, LCMS for Nitrosamine, Dissolution and related techniques.
• Perform literature search, patent landscape review, and regulation comparison. Review guidelines and API vendor DMF. Read the pharmacopeias and technical documents to understand the latest knowledge of the OINDP pharmaceutical industry.
• Participate in Analytical methods Technology transfer to GMP labs to support for manufacture pilot, scale up, submission & commercial batches
• Review the documents and electronic records. Prepare analytical protocols, reports and CMC documents. Monitor data trending and support for deficiency letter response. Ensure good documentation practices and data integrity.
• Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection.
• Train and mentor analysts in day-to-day laboratory operations. Support relevant departments and customers to complete projects on time. Ensure all activities and analysis comply with applicable GMP, correct procedures, regulatory guidelines, and health and safety regulations
• Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival
• Support laboratory management work, e.g., reference/working standard management, instrument management, work area cleaning, reagents and solvents, and other supporting systems
• Prepare technical documents, as per ICH requirements for analytical method development, protocols and reports.
• Prepare regulatory submission documents as per ICH including chemistry manufacturing & controls (CMC), method development report etc.
• Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers
• Collaborate with cross-functional teams on project timelines and deliverables in compliance with PIC/S GMP, USFDA, ICH, and other global regulations

Requirement

• Master's degree or above in Pharmacy, Chemistry, Biology, or related field
• Minimum 5-12 years of experience in Analytical Research and Development function(formulations) in pharmaceutical industry, with experience in pMDI ,Nasal spray, DPI
• Hands on experience on analytical equipment's HPLC, NGI, Realistic APSD, DUSA, Malvern Mastersizer, MDRS & Dissolution
• In-depth knowledge of PIC/S GMP, ICH Q-series, FDA/EMA regulations
• Strong documentation, analytical, and Pharmacopoeia and Regulatory knowledge (USFDA, EMA), Analytical instrument troubleshooting, Support formulation screening
• Soft skills requirement: Drive for Results, Teamwork, Service Mindset, Embracing Change and Problem-Solving skills.

#Intech Biopharm. Ltd 益得生技

#Synmosa Biopharma Corporation

#HIRING

#WeAreHiriing

#Talent

#ResearchAndDevelopment

#AnalyticalResearch