Company Mission:
With passion, purpose and partnerships, we transform scientific discoveries into advances in human healthcare and deliver quality medicines to patients whenever and wherever they need it
Job Mission:
Global Quality is an international organization committed to ensuring the availability of safe and effective Biogen Idec medicines that meet or exceed patient requirements worldwide. We accomplish this by collaborating across functions, Biogen Idec locations, and with our business partners to proactively develop best compliance practices to regulatory expectations, excellence in technical approaches, and continuous improvement to build efficiency and flexibility in our quality systems. Our patient focus is supported by a culture of integrity, dedication, innovation, and accountability.
Job Duties:
The Associate III, QC Stability will support operational and technical aspects of clinical drug substance, drug product, reference standard, and placebo GMP stability programs, ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and FDA guidelines, and provide technical expertise and leadership for the stability program of commercial and clinical products. This includes design of stability protocols, expiry dating for clinical products, providing stability sections for submissions, technical assessment of stability specification changes and stability investigations. Additionally, this role will be responsible for ensuring external partner recommendations and requirements are incorporated into the stability program and Quality systems.
Summary of Key Responsibilities:
Design and oversee stability protocols with supervision
Assign drug substance, drug product, and reference standard expiry
Trend and evaluate stability data proactively
Guide Sample Handling Group in proper storage of stability samples
Guide testing labs (in-house and contract) in proper testing / reporting of stability samples
Alert Quality organization about potential issues and evaluate remedial actions
Author stability reports for regulatory submissions with supervision
Contribute to laboratory investigations (deviations, OOS, cross-site and cross-functional)
Participate on CMC teams and attend regular meetings
LI-POT1 Qualifications -Minimum of 3 years direct experience in stability/formulation of biological and/or small molecule products in the Pharmaceutical industry, with 5-7 years industry experience
Knowledge of analytical methods and ability to analyze data
Good understanding of statistical analysis and interpretation of data
Proficiency in GMP
Experience in Excel and LIMS
Strong technical writing and communication skills Education -Bachelor's Degree in Biology, Chemistry, Biochemistry, Chemical/Biochemical Engineering, or related disciplines with equivalent experience.
