**MEMBERS ONLY**SIGN UP NOW***. (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, womens health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
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This position will be responsible for functioning as the Lead Analyst for the BSL QC group (Microbiology or Chemistry) and all associated support functions, ensuring that all Microbiology, Chemical, Potency and/or Biochemical testing is performed according to the FDA, Foreign MOH and Allergan requirements.
This individual will verify that the quality of drug substance product meets all Regulatory commitments, assist in the daily activities related to the product stability testing program, and manage routine communication with contract testing facilities. The individual will collaborate with and effectively represent QC in meetings with internal and external partner groups under the leadership of the QC Manager.
Main Areas of Responsibilities
Supervise and train in the areas of QC (Microbiology or Chemistry), compliance, and documentation preparation.
Responsible for writing, reviewing testing procedures, and streamlining same in order to increase lab efficiency.
This individual will serve as a technical resource representing QC during FDA and Ministry of Health inspections.
The individual will be responsible to ensure appropriate training and development plans are in place for all employees in the QC group.
The individual will be expected to lead and participate in continuous improvement activities within the Drug Substance Operations (DSO).
Implement, perform and coordinate all laboratory tests and review raw data and certificate of analysis for raw materials, in-process test data, and final product test results.
Perform Analytical and Microbiological testing as required.
Contribute to the review of SOPs. Prepare and/or revise SOPs as necessary. Authors SOPs.
Support performance qualification, validation studies and routine validation requirements.
Lead the BSL QC function to ensure all method transfers are completed in a timely phase appropriate compliant manner.
Demonstrated knowledge and experience with validating QC methods.
Working knowledge of regulatory compliance and pre-clinical production of protein therapeutics and a thorough understanding of the integration of the two in clinical manufacturing. Experience working in a GMP environment. Familiarity with process characterization and process validation.
Demonstrated ability to manage, multi-task, delegate, and retain flexibility in a dynamic environment.
Well-developed written and oral communication skills. Motivated to work in a team environment.
Consistently deliver on commitments and respond to customers’ needs in a timely and courteous manner.
Demonstrated knowledge of the use of a continuous improvement methodology in a lab testing environment, desired but not essential
MS in Chemistry/Biochemistry or a related Biological Science field with 4 years of relevant industrial experience or BS in Chemistry/Biochemistry or a related Biological Science field with 6 years of relevant industrial experience.
3-5 years of experience within a technical environment