Erica Yin
Mount Eden,AUK
Summary
Analytical development leader with extensive experience in pharmaceutical and agricultural product development. Specializes in analytical method development, verification, validation, and product specification under cGMP and (V)ICH guidelines. Proven ability to lead cross-functional R&D projects, manage laboratory operations, and ensure regulatory compliance while overseeing analytical budgets. Recognized for enhancing laboratory systems to support GMP accreditation and facilitate successful product approvals.
Overview
26
26
years of professional experience
Work History
Head of Analytical Development and Laboratory
RuminantBiotech
04.2024 - Current
- Led, mentor, and develop a high-performing Analytical Development & Laboratory team.
- Define the analytical development and laboratory operation strategy aligned with company goals, R&D milestones, and regulatory requirements.
- Led analytical activities for product development, including method development, validation, and transfer to support R&D, CMC, and product release.
- Established product specifications for raw materials, finished products release and stability studies, as well as control strategies to support pilot‑scale manufacturing.
- Oversaw product stability program by planning stability studies and reviewing analytical results for quality impact.
- Prepared documentation to support regulatory submissions, including test methods, validation protocols and validation reports, stability study protocols and reports, product specifications and COAs.
- Addressed deficiency questions from external data assessors or regulatory authorities, e.g., ACVM.
- Collaborated with external partners on analytical testing while managing project budgets and deliverables.
Senior Research Scientist
Douglas Pharmaceutical LTD
Auckland, AUK
07.2019 - 03.2024
- Developed and verified analytical test methods for raw materials, enhancing support for product development.
- Developed finished products analytical test methods, including assay, related substances, dissolution, residue solvent, cleaning validation and verification to monitor new product quality profile and support project progress.
- Executed pre-validation and analytical test method assurance activities to meet regulatory guidelines and product submission requirements.
- Prepared analytical test method development work plans, protocols, and reports, ensuring compliance with regulatory standards.
Gas Chromatography Analyst
Douglas Pharmaceutical LTD
Auckland, AUK
10.2017 - 07.2019
- Performed GC testing of API, excipients and finished products supporting product release.
- Test method qualification and re qualification to comply with regulatory authority requirement.
- Involved in GC instrument maintenance and calibration, troubleshooting, CRN, QI and LIMS activities.
Technical Support Analyst/Officer
Douglas Pharmaceutical LTD
Auckland, AUK
03.2010 - 10.2017
- Developed and validated analytical methods for assay related substances in existing products.
- Verified pharmacopeia methods for assay related substances and dissolution to ensure compliance with industry standards.
- Conducted analytical method technical transfers to support business operations.
- Performed product process validation and equipment cleaning verification activities.
- Provided data supporting manufacturing processes to ensure compliance and efficiency.
- Created analytical methods for dust, chemical management, and air quality assessments.
- Evaluated problematic samples and customer complaints, providing timely technical responses to enhance customer satisfaction.
- Developed work plans and protocols, summarizing results in technical reports to support regulatory submissions.
Stability Analyst
Douglas Pharmaceutical LTD
Auckland, AUK
12.2007 - 03.2010
- Test and report in-house products and CMO finished product and stability samples using assigned techniques, methods and procedures to support product pre submission and after approval requirement.
- Conducted stability sample LIR and initiated OOS investigations.
- Sorted and categorized stability samples for easy access.
Laboratory Technician ,
Assurquality
10.2006 - 12.2007
- Executed quality testing of products, ensuring compliance with laboratory standards and protocols.
- Prepared samples and quantified vitamin A, D, E, ß-carotene, and choline in food and supplements, supporting nutritional analysis.
- Performed microbial tests on health and pharmaceutical products, accurately documenting results to uphold product safety.
Pharmacy Technician
Pharmacy One
Auckland, AUK
08.2004 - 05.2005
- Dispensed medications accurately following prescriptions and pharmacy protocols.
- Supported pharmacists in inventory management and ensured timely restocking of shelves.
Department Manager & Pharmacist
Tongji Hospital, Wuhan,China
, Wuhan,China
10.1999 - 08.2003
- Oversaw daily pharmacy operations, including prescription dispensing and patient medication counseling.
- Managed inventory control and supervised pharmacy personnel to maintain efficiency.
- Directed departmental operations to ensure adherence to hospital policies.
- Developed comprehensive plans based on overarching guidance for departmental functions.
Education
Master of Science - Pharmaceutical Sciences
University of Auckland -
11-2006
Bachelor of Science - Pharmaceutical Sciences
China Pharmaceutical University
Nanjin, ChinaSkills
- Analytical method development and validation
- People management and coaching
- Quality control testing
- Regulatory compliance
- Laboratory instrument expertise, including HPLC/UPLC, GC‑FID/GC‑MS, Dissolution apparatus and UV-spectrometer
- Experimental design and data analysis
- GMP and GLP knowledge
- Problem-solving and time management
Timeline
Head of Analytical Development and Laboratory
RuminantBiotech
04.2024 - Current
Senior Research Scientist
Douglas Pharmaceutical LTD
07.2019 - 03.2024
Gas Chromatography Analyst
Douglas Pharmaceutical LTD
10.2017 - 07.2019
Technical Support Analyst/Officer
Douglas Pharmaceutical LTD
03.2010 - 10.2017
Stability Analyst
Douglas Pharmaceutical LTD
12.2007 - 03.2010
Laboratory Technician ,
Assurquality
10.2006 - 12.2007
Pharmacy Technician
Pharmacy One
08.2004 - 05.2005
Department Manager & Pharmacist
Tongji Hospital, Wuhan,China
10.1999 - 08.2003
Master of Science - Pharmaceutical Sciences
University of Auckland -
Bachelor of Science - Pharmaceutical Sciences
China Pharmaceutical University