M&S-Quality Control Expert Microbiology IFB (Microbiology)

Location: Beijing, China; onsite role

Company

hirify.global is developing a large, automated and modern biologics facility for insulin drug substance manufacturing in Beijing.

What you will do

• Establish the microbiology quality control laboratory from planning and qualification through approval and transition to routine operations.
• Provide microbiological expertise for analytical projects, troubleshooting and investigations involving laboratory technologies.
• Create and review protocols, reports and standard operating procedures for analytical verification, validation, transfer and equipment qualification.
• Execute quality tests and workflows in accordance with cGMP, HSE, data integrity and regulatory requirements.
• Document raw data, deviations, non-conformities, corrective actions and quality or HSE events.
• Support delivery of the microbiology QC project within budget, schedule, quality and HSE objectives while collaborating with Frankfurt, MSAT and global subject-matter experts.

Requirements

• Degree in Microbiology, Pharmacy, Biochemistry or an equivalent discipline; an MSc or PhD is preferred.
• At least 5 years of pharmaceutical or biotechnology industry experience, preferably in microbiology analytical method transfer or verification and instrument qualification or validation.
• Project leadership experience with a proven record of delivery and compliance.
• Proficiency in microbiological techniques and in-depth knowledge of GMP principles, data integrity and health-regulated requirements.
• Experience in scientific and technical writing, strategic planning, risk analysis and effective communication.
• Experience with automation, LIMS, international regulations or FDA requirements is preferred.

Culture & Benefits

• Supportive, future-focused environment centered on applying science to healthcare.
• Opportunities for professional growth through promotion or lateral and international moves.
• Rewards package designed to recognize individual contribution.
• Healthcare, prevention and wellness benefits for employees and families.
• At least 14 weeks of gender-neutral parental leave.