Company:Array BioPharma Inc. is a fully-integrated, biopharmaceutical company focused on the discovery, development and commercialization of transformative and well-tolerated targeted small molecule drugs to treat patients afflicted with cancer and other high-burden diseases. Array markets in the United States BRAFTOVI (encorafenib) capsules in combination with MEKTOVI (binimetinib) tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation. Arrays lead clinical programs, encorafenib and binimetinib, are being investigated in over 30 clinical trials across a number of solid tumor indications, including a Phase 3 trial in BRAF-mutant colorectal cancer.Summary:Residing in our Boulder, CO office, will provide quality oversight of external contract manufacturers, packagers, and laboratories engaged in early through late phase development of pharmaceutical drug substances and drug products. Will ensure that assigned products are manufactured, packaged, analyzed, released, stored and distributed in accordance with Array standards and all applicable regulatory requirements. This includes change control, deviations/investigations, technical transfers, and product quality oversight of Phase 1, 2, and 3 clinical supplies. Will provide support to ensure effective quality systems at the partner and supports continuous improvement activities.Responsibilities:The candidate builds and maintains strong relationships with contractors, remains informed of current GMP requirements and industry trends, supports review of regulatory filings, and advises internal departments and contractors on aspects of GMP complianceActs as the Array Quality point of contact for all quality activities. Implements, maintains and ensures contractor adherence to Array standards and regulatory requirements documented in the Quality AgreementPartners with contractors during regular site visits to address continuous improvement initiatives, remediation efforts, and ongoing projectsFunction as \"Person in Plant\" at contractors facility to support remediation or routine productionGuides contractor investigations of abnormal operational occurrences such as batch rejections, atypical events, quality defects, etc. with support from Supply Chain and Manufacturing, and Regulatory, as requiredEnsure appropriate handling and filing of contractor records at Array according to document management proceduresReviews and approves contractor documentation including Stability Protocols/Reports, Major and Critical Deviations, Change Controls, Out of specification investigations, Method transfer and validation protocols and reports, process development/transfer protocols and reports, product specifications, master batch records, etc.Supports audits of assigned contractors by assisting in the preparation, observing, and following up on any resulting corrective actionsProvides guidance to contractors regarding product compliance, procedures, regulatory requirements and guidelinesReviews relevant drug application modules for accuracy and completeness, verifying source documentation, prior to submission to relevant authoritiesEnsure execution of the relevant escalation processes and prompt communication of GMP Compliance risks to Array ManagementSkills & RequirementsRequirements:BS/BA in Chemistry with organic synthesis experience (or equivalent)10+ years of experience in the pharmaceutical industry or other regulated environment with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of cGMP and regulatory requirements.3+ years supervisory experienceContract manufacturer management experienceDrug substance process and manufacturing quality experienceExperience in leading change and a demonstrated ability to accomplish results and meet deadlines and commitmentsDemonstrated analytical and logic skills with a focus on fact-based decision making and problem-solvingStrong collaboration, organization, and written /verbal communications skillsAbility to travel up to 30%We offer an excellent compensation package including a competitive salary, company ownership, comprehensive benefits and the opportunity to be part of a dynamic biotech environment.Array BioPharma has locations in Boulder, Colorado; Cambridge, Massachusetts; and Morrisville, North Carolina.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.Array is a drug free workplace. All employment offers are contingent upon the applicant successfully completing drug and background screening. Associated topics: bio, biomaterials, biomedical, biomedical engineer, biophysics, enzyme, fermentation, neuro, nutrition, parenteral
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