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This portfolio have clear owners, milestones, risks, and benefits. Additionally, create standardized COGM/productivity dashboards and benefit tracking with Finance.</li>\n</ul>\n<ul>\n<li>Lead programs (cycle time, labor models, MES/EBR enablement, yield, changeovers/scheduling, deviation reduction, automation/technology insertion). Apply the AZ Lean Model (A3, VSM, standard work, daily/tier management, leader standard work, adapted SMED).</li>\n</ul>\n<ul>\n<li>Facilitate development of business processes for training, batch execution, deviations, and patient/lot scheduling and logistics.</li>\n</ul>\n<ul>\n<li>Lead Kaizen events; scale best practices across the Cell Therapy Development and Operations.</li>\n</ul>\n<ul>\n<li>Define basic conditions for Cell Therapy Manufacturing Sites and build capability at all levels; coach leaders and value stream owners</li>\n</ul>\n<ul>\n<li>Partner with Supply Chain to vein-to-vein flow, slotting, and cold-chain logistics, safeguarding Chain of Identity/Chain of Custody.</li>\n</ul>\n<ul>\n<li>Ensure improvements uphold safety, patient focus, and cGMP for ATMPs (including GAMP and data integrity). 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As a key member of our production and manufacturing department, you will be responsible for setting up, operating, maintaining, and troubleshooting manufacturing production that includes isolators, aseptic filling equipment, mixers, pumps, biosafety cabinets, glove integrity testers, environmental monitoring equipment, etc.</p>\n<p>Your primary responsibilities will include:</p>\n<ul>\n<li>Responsible for clinical manufacturing novel cell therapy drug substance within the Cell Therapy Module, CT-MOD.</li>\n<li>Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment.</li>\n<li>Works with a single-cell line from expansion, through differentiation and fill/finish process to manufacture a unique product using single-use technology.</li>\n<li>Manufactures products in various phases of product life cycles from clinical through launch.</li>\n<li>Responsible for all aspects of clinical manufacturing in the following areas: Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing.</li>\n</ul>\n<p>In addition, you will:</p>\n<ul>\n<li>Ensure all activities are performed to schedule.</li>\n<li>Clearly understand, communicate, and manage differences in terms of documentation, sample handling, automation, cGMPs, etc. for different phases of the product life cycle.</li>\n<li>Author, redline, and review-controlled documents for various equipment/processes.</li>\n<li>Monitor and control processes using data trending and/or statistical process control.</li>\n<li>Work cross-functionally to ensure process is controlled and issues are escalated and investigated.</li>\n<li>Raise and support investigation of deviations.</li>\n<li>Partner cross-functionally to determine product impact and root cause.</li>\n<li>Implement and execute manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence.</li>\n<li>Participate in regulatory and internal audits.</li>\n<li>Support commissioning and qualification of equipment.</li>\n<li>Participate in safety investigations for CT-MOD and always promote safe behaviors.</li>\n<li>Partner cross-functionally to identify and implement corrective actions.</li>\n</ul>\n<p>If you have experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience, and possess a strong understanding of FDA, EMA, etc., and cGMP requirements for pharmaceutical manufacturing, we encourage you to apply for this exciting opportunity.</p>\n<p>We offer a competitive salary range of $64,000.00 – $97,000.00, additional compensation may include a bonus or commission (if relevant), and a comprehensive benefits package, including health care, vision, dental, retirement, PTO, sick leave, etc.</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_1c635149-b1e","directApply":true,"hiringOrganization":{"@type":"Organization","name":"Bayer","sameAs":"https://talent.bayer.com","logo":"https://logos.yubhub.co/talent.bayer.com.png"},"x-apply-url":"https://talent.bayer.com/careers/job/562949976864196","x-work-arrangement":"onsite","x-experience-level":"mid","x-job-type":"full-time","x-salary-range":"$64,000.00 – $97,000.00","x-skills-required":["pharmaceutical operations","biotech","FDA","EMA","cGMP","Lean manufacturing principles","business IT systems","Microsoft Office Suite"],"x-skills-preferred":[],"datePosted":"2026-04-24T14:10:21.264Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Berkeley"}},"employmentType":"FULL_TIME","occupationalCategory":"Manufacturing","industry":"Healthcare","skills":"pharmaceutical operations, biotech, FDA, EMA, cGMP, Lean manufacturing principles, business IT systems, Microsoft Office Suite","baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":64000,"maxValue":97000,"unitText":"YEAR"}}},{"@context":"https://schema.org","@type":"JobPosting","identifier":{"@type":"PropertyValue","name":"YubHub","value":"job_3d46203d-ce0"},"title":"Senior Director Global Oral Solid Dosage Forms (Global OSD), Technical Operations, Science & Innovation","description":"<p>Are you ready to lead a team that makes a difference in the pharmaceutical industry? This senior leadership role provides strategic and operational direction for the global organisation responsible for on-market technical support to AstraZeneca’s commercial Oral Solid Dosage (OSD) portfolio.</p>\n<p>Based in Mount Vernon, US, the position leads a high-performing team that supports OSD platform teams and senior scientific experts, ensuring robust, reliable and innovative manufacturing performance across the product lifecycle.</p>\n<p>In this role, the Senior Director Global OSD leads and develops a diverse technical organisation focused on delivering strong product and process performance for AstraZeneca’s commercial OSD portfolio. 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Support responses to health authority questions.</li>\n</ul>\n<ul>\n<li>Partner closely with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Project Management leads to ensure seamless integration of manufacturing activities into overall program execution.</li>\n</ul>\n<ul>\n<li>Collaborate with procurement to ensure timely contracting for drug product manufacturing.</li>\n</ul>\n<p><strong>About You</strong></p>\n<ul>\n<li>MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.</li>\n</ul>\n<ul>\n<li>6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug product manufacturing, formulation development, and fill-finish operations.</li>\n</ul>\n<ul>\n<li>Demonstrated track record of successfully managing drug product manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.</li>\n</ul>\n<ul>\n<li>Technical expertise in aseptic fill-finish operations, lyophilization processes, formulation development, stability programs, and drug product characterization for biologics.</li>\n</ul>\n<ul>\n<li>Extensive experience working with CDMOs and contract manufacturing organizations, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.</li>\n</ul>\n<ul>\n<li>Strong knowledge of cGMP regulations, FDA and EMA guidelines, ICH quality guidelines, and regulatory expectations for drug product manufacturing.</li>\n</ul>\n<ul>\n<li>Experience authoring and reviewing CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing and validation activities.</li>\n</ul>\n<ul>\n<li>Strong project management skills with demonstrated ability to manage multiple manufacturing programs simultaneously, meet aggressive timelines, and navigate competing priorities.</li>\n</ul>\n<ul>\n<li>Excellent communication and interpersonal skills with ability to influence and build strong relationships with internal stakeholders and external manufacturing partners.</li>\n</ul>\n<ul>\n<li>Willingness to travel domestically and internationally (approximately 20-30%) to manufacturing sites for audits, manufacturing oversight, and technical meetings.</li>\n</ul>\n<p><strong>Total Compensation Range</strong></p>\n<p>$177,000 - $235,000</p>\n<p><strong>Where We Hire</strong></p>\n<p>Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. 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