Associate Director Quality Control (Technical Resources)
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary . Provide leadership, technical support, guidance and supervision for release, stability, and in-process testing and assay development . Essential Duties and Responsibilities include, but are not limited to, the following . Review new test procedures and assays . May evaluate and bring in new methodologies/techniques when needed . Participate in technical troubleshooting and problem investigation . Review analytical development report, assay and process validation report, shipping validation and other technical documents for technical correctness and regulatory compliance . Collaborate with members of Process Analytical Sciences, Manufacturing, Stability, and Business Ops to provide analytical support . Provide technical support to reference standard trending group . Provide technical support to QC stability group for data analysis, trend evaluation and for investigation . Maintains Project Management of Method validations. Report progress monthly to upper management and reports any deficiencies . Post validation method improvement Change controls, CIs . Performs personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations . Knowledge, skills and abilities . Strong analytical and protein chemistry background . Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices . Develop strategy and create metrics to measure effectiveness of strategy . Lead through ambiguity and translate into actionable steps . Provide leadership to direct and indirect reports . Coaching and conflict resolution . Handle issues appropriately and with a sense of urgency . Prioritize based on business needs . Identify and effectively communicate risks . Ability to problem solve and identify root cause . Ability to communicate at all levels and across various functions . Ability to build, lead, and motivate team . Education and Experience . Requires BS in Life Sciences, or related field, with a minimum of 10 years relevant experience in the pharmaceutical or biotechnology industry. PhD preferred . Requires previous management experience #LI-AP1 . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law .