Senior Specialist，，QC Molecule at AstraZeneca

, , China -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

0.0

Posted On

04 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

qPCR, dPCR, Nucleic Acid Gel Electrophoresis, Molecular Laboratory Quality Standards, Molecular Diagnostic Techniques, Analytical Method Optimization, SOP Drafting, Stability Testing, Training, Supplier Audits, Instrument Maintenance, GMP Compliance, Data Review, Communication, Teamwork, Interpersonal Skills

Industry

Pharmaceutical Manufacturing

Description

Major responsibilities Proficient in qPCR, dPCR, and nucleic acid gel electrophoresis; perform planned testing of plasmid, lentiviral, and cellular samples, complete testing records, conduct result review, issue test reports, and promptly escalate to supervisors as required. Comply with molecular laboratory area requirements and contribute to establishing GMP‑compliant area management policies and workflows. Participate in drafting SOPs for molecular analytical methods applied to in‑process controls, intermediates, and finished products. Propose or participate in analytical method optimization, and support method transfer and validation, including protocol development, experimental execution, report drafting, and investigation of anomalies. Contribute to stability study protocol development for intermediates and finished products; participate in stability testing and perform stability data review. Participate in training of molecular testing technicians, including onboarding of new hires and refresher/continuing training (e.g., GMP regulations, technical knowledge, and molecular testing SOPs). Support product annual reviews. Identify suitable outsourced testing service providers based on business needs; participate in supplier audits, arrange sample submission, promptly collect outsourced test reports, and verify that results meet requirements. Manage instrument login account permissions and original data associated with molecular testing. Procure molecular testing reagents, consumables, and reference standards per plan to meet routine testing needs, and store/manage them per applicable procedures. Ensure proper operation and routine maintenance of molecular testing instruments and equipment; report malfunctions for timely repair. Support internal and external audits and complete remediation per plan and requirements. Complete other laboratory‑related tasks assigned by management on schedule. Education, Qualifications, Skills and Experience A bachelor’s degree or higher in Chemistry, Biopharmaceutical Analysis, Molecular Biology, Cell Biology, Immunology, or a closely related discipline is required. At least three years of experience in pharmaceutical testing or pharmaceutical quality-related functions. Familiarity with molecular laboratory quality standards for pharmaceuticals and proficiency in molecular diagnostic techniques, including nucleic acid–based assays. Familiarity with the major laws and regulations of the NMPA. Strong organizational, communication, and teamwork capabilities, with well‑developed interpersonal skills to interact effectively across multiple teams. Date Posted 04-1月-2026 Closing Date 30-5月-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. Regardless of role or level, we’re all connected by our purpose and drive to impact patients’ lives. As part of our Early Talent Programmes, you’ll play an integral part in living our values and helping us to deliver on this shared ambition. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Senior Specialist in QC Molecule will perform testing of various biological samples and ensure compliance with GMP standards. Responsibilities include drafting SOPs, supporting method validation, and training technicians.