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Director, External Manufacturing Site Lead at Halozyme Therapeutics

Director, External Manufacturing Site Lead

Halozyme Therapeutics Hopkins, MN (On Site) Full-Time
Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.  In order to move forward, you will need to create an account.   Your password must be eight characters long, contain at least one special character, one capital letter and a number. We look forward to discovering your talents.Director, External Manufacturing Site LeadWelcome to an inspired careerAt Halozyme, we’re proud of what we do, and we continue to do more. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo and advancing our mission.Join us as a Director, External Manufacturing Site Lead and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.How you will make an impactAs the Director, External Manufacturing Site Lead you will be a member of the External Manufacturing Site Lead (EMSL) team and oversee and support all aspects of external operations at Halozyme’s contract development and manufacturing organizations (CDMOs), as well as supporting the internal cross-functional CDMO site teams.  The EMSL ensures adherence to manufacturing and quality standards, contractual agreements, budgets and schedules, to ensure timely and in-full delivery of product. They lead  performance of the CDMO through regular business review meetings and will hold the CDMO accountable to defined key performance indicators.In this role, you’ll have the opportunity to: Lead and provide oversight for all aspects of CMC operations at contract manufacturing sitesPromote cross-functional teamwork to drive alignment on key issues, deliverables, timelines, and strategiesAddress urgent issues and lead internal functional teams to accurately disseminate information and assist with path forwardEnsure timely resolutions and seek escalation through established governance structure should a compromise not be reached at the functional levelProvide single point of accountability with the CDMO to ensure business objectives, timelines, and manufacturing, testing, supply, and quality deliverables are met including:Alignment on production planningOn time, in-full delivery per agreed planResolution of operational and quality issuesIdentification of quality / technical (process and analytical) / business / Safety Health Environmental (SHE) risks and leadership on related mitigation and corrective actionsMonitor CDMO performance against established KPIs, internal metrics and trends to drive performance improvementsEngage as a member of the Platform Governance leadership team to set strategic direction, resolve issues, and prioritize resourcesTo succeed in this role, you’ll need: Minimum of BS degree in relevant scientific, engineering, or technical discipline(s) with minimum 10 years’ experience in combination product cGMP manufacturing and/or technical area (an equivalent combination of education/experience will be considered)5+ years’ experience leading a cross functional team, ideally CDMO management experience with operations and business management experienceDetailed technical understanding of cGMP manufacturing of combination productsStrong project management with proven ability to supervise execution of technical projects and facilitate meetings including documenting meetings, decisions, risks, and actionsExperience in building CDMO/vendor business processesSolid understanding of cGMP regulations and regulatory requirements to assess the health of the CDMO operations, interpret SOPs to regulations and provideIn return, we offer you: Hybrid work flexibilityFull and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matchingOpportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursementA collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.,The most likely base pay range for this position is $164K - $225K per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.SummaryLocation: Minnesota - Minnetonka (12500 Whitewater Drive)Type: Full time

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