ACCOUNTABILITIES:

As a Laboratory Manager, you will be at the forefront of ensuring the smooth operation of our Dosage Form Design and Development Laboratories. Your responsibilities will include overseeing daily laboratory operations in Gaithersburg, Maryland, while aligning strategic compliance and training with our Cambridge, UK laboratories. You will manage laboratory organization, equipment, and facility management, ensuring readiness for inspections and audits. Supporting approximately 100 lab-based staff, you will develop and implement efficient processes and workflows that prioritize safety, compliance, and operational excellence. Your leadership will guide laboratory staff in correct procedures and protocols, fostering collaboration with cross-functional teams to support diverse research projects. Additionally, you will troubleshoot equipment issues, coordinate repairs, and stay updated on emerging technologies and industry best practices.

ESSENTIAL SKILLS/EXPERIENCE:

• B.S. with a minimum of 15+ years of experience,
• M.S. with a minimum of 13+ years of experience
• Ph.D. with 7+ years of experience.
• Must have a degree in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or relevant field.
• Experience working in a pharmaceutical industry laboratory environment is highly desired.
• Minimum of 5 years of experience in a laboratory setting, preferably in a pharmaceutical or biotechnology company.
• Possess technical knowledge and expertise in biophysical characterization techniques, analytical instrumentation, laboratory techniques, equipment, and procedures.
• Strong leadership, organizational, and communication skills.
• Familiarity with regulatory requirements and compliance in the pharmaceutical industry, including FDA and GxP requirements.

DESIRABLE SKILLS/EXPERIENCE:

• Knowledge of protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or biophysical analytical methods.
• Previous experience in managing a team or leading projects
• Experience working with mAbs, bispecifics, Fusion Proteins ADCs, TCEs, and other related biotherapeutic modalities.
• Experience developing drug/device combination products.
• Experience with inspections and audits by providing guidance to audit team and/or managing responses to auditors.
  At AstraZeneca, you’ll find yourself among a community of highly qualified scientists who are both supportive and challenging. We foster an environment of continuous learning and knowledge sharing, encouraging constructive critique to drive innovation. Our dedication to improving patient outcomes means every challenge is an opportunity for growth. Here, your expertise will be valued as you contribute to groundbreaking solutions that make a tangible difference in society.

Please refer the Job description for details