48 process operator jobs found

Biogen This position will be hybrid (3 days per week on site) and can either sit at our Cambridge MA location OR our Research Triangle Park, NC location About This Role The Sr Manager, Supply Chain Quality Lead is responsible for providing oversight and support to all distribution quality related activities within the USA. They are responsible for developing quality awareness and inclusion in all processes and facilitate or mentor processes required for the establishment of effective quality management systems. The Sr Manager will liaise with all functions within our Pharma Operations & Technology division and outside to assure seamless processes and patient access to medicines. This person will have QA oversight of logistics of products' distribution worldwide and management of deviations, CAPAs, Change Controls, audits and serialization. What You'll Do Ensure quality and uninterrupted supply through the application of quality measures throughout the supply...

Biogen Job Title: Sr. Analyst I, Material Planning About This Role: As a Sr. Analyst I in Material Planning, you will play a pivotal role in supporting manufacturing planning efforts at our RTP Pharma Manufacturing Site, focusing on both clinical and commercial programs. You will work closely with teams across Manufacturing, Warehouse, Scheduling, Quality, and Procurement to address raw material issues, manage scheduling conflicts, and ensure optimal inventory levels. Your role is integral to driving project success, as you resolve issues and report project status to both your team and management. With a keen eye on analyzing data to help reduce costs and mitigate write-offs. This position requires a balance of independent work and effective collaboration across all business areas and organizational levels. What You'll Do: Manage raw materials planning and inventory control activities, including forecasted demand, stock levels, and expiry reporting. Oversee weekly...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead. What You'll Do Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation. Act as the back up to the Clinical Data Lead, providing subject matter expertise and...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle. What You'll Do Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress. Accountable for all Data Management...

Biogen About This Role: As the Associate Director of Business Planning, you will be a pivotal part of the Biogen North America (BNA) Commercial pharma finance team. Tasked with delivering strategic financial insights, you will play a critical role in financial reporting, forecasting, and business planning activities. In this position, you will work closely with the Head of Financial Planning & Analysis (FP&A) to ensure the accuracy of financial data and provide meaningful analytics that support impactful business decisions. Your collaboration with BNA finance team leadership and functional business partners, such as Market Access and Medical, will be key. You will also lead special projects, designing innovative processes for operating expense tracking and oversight, while managing routine budgeting processes and financial reporting. Your role involves overseeing investments across the organization, working in partnership with the Office of the President and Commercial...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead. What You'll Do Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation. Act as the back up to the Clinical Data Lead, providing subject matter expertise and...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle. What You'll Do Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress. Accountable for all Data Management...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They provide operational leadership and are accountable for all Clinical Data Management activities throughout the clinical study lifecycle. What You'll Do Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress. Accountable for all Data Management...

Biogen About This Role Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead. What You'll Do Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation. Act as the back up to the Clinical Data Lead, providing subject matter expertise and...

Merck Job Description Location: Boston, MA Department: Biology-Discovery / Neuroscience Our Company's Neuroscience is recruiting a Principal Scientist in Boston/Cambridge, MA to develop and oversee implementation of biomarker discovery and translational strategies. We are seeking a highly motivated and experienced scientist to join our Neuroscience team in a role that will drive biomarker discovery and enable clinical translation by integrating cutting-edge data analytics, novel assay development, and cross-functional collaboration. The successful candidate will be an experienced Neuroscientist with expertise in drug discovery, novel biomarker discovery, and assay developmentacross diverse platforms. You will collaborate across multiple drug discovery teams and functional areas including Discovery, Translational Experimental Medicine, Translational Genome Analytics and Quantitative Pharmacometrics teams. You will develop experimental strategies that leverage in...

Biogen About This Role: As the Lead Deskside Support Analyst, you will be an integral part of the IT Deskside Services team, guiding all aspects of day-to-day incidents, tasks, and project delivery operations throughout the enterprise. This position requires you to help oversee onboarding support, equipment provisioning and deprovisioning, and provide deskside, labs, commercial, and VIP support. You will also manage onsite and offsite meetings and events, along with ServiceNow queue management. Serving as a technical mentor, you will offer training resources to internal and external team members, ensuring high customer satisfaction and smooth business operations. Additionally, you will document key deskside support processes, create training materials, and uphold support standards. Occasional travel may be required to provide support for external events, contributing to uninterrupted business operations and minimal escalations. What You'll Do: Serve as the one of the...

Biogen This position is a M-F business hours schedule (8A-5P) and is full time on-site at our RTP facility About This Role As an Associate III, QC Raw Materials, you will play an integral role in the Quality Control Raw Materials team at the Biogen RTP Pharma site. This critical position supports functional, tactical, and operational objectives by sampling, inspecting, and testing raw materials while maintaining strict adherence to cGMP documentation standards. Your expertise in Gas Chromatography (GC) and wet chemistry will be essential as you perform compendial testing and manage data entry into electronic laboratory information management and inventory systems. Collaborating closely with QC teams, Quality, Planning, Warehouse, Validation, and Manufacturing teams, you will help ensure that operations run smoothly. Your role may also involve assisting with GMP compliance activities, investigation writing, and continuous improvement initiatives. By working independently and...

Biogen About This Role: We are seeking a Director of Advanced Analytics, Data Science & AI to spearhead efforts in generating and delivering data-driven insights that bolster a brand, therapeutic area, or cross-brand/enterprise initiatives, enhancing our innovative capabilities. Positioned at the heart of our strategic endeavors, this role involves influencing business partners, leading the execution and interpretation of AI/ML models, framing complex problems, and crafting compelling solutions. You will play a pivotal role in communicating clear and impactful data-driven insights across various teams. This dynamic and fast-paced position within a highly collaborative environment covers a broad range of strategic topics critical to our business success. To excel, you must possess an unwavering passion for data-driven problem solving, a robust background in data science and AI, and a track record of leading and developing high-performing teams that drive meaningful change...

Biogen About the Role: The Head of Portfolio and Project Management at the Biogen West Coast Hub (WCH) is a leadership role with strategic, enterprise-level responsibilities focusing on transformation and operational efficiency. This leader is accountable for shaping and executing portfolio strategy, driving an operational efficient PM organization, and ensuring operational excellence across clinical programs at the West Coast Hub (WCH). What You'll do: 1. Strategic Leadership & Portfolio Management Define and implement the WCH portfolio and project management strategy, aligning with enterprise objectives. Lead the Portfolio & Project Management function, influencing organizational direction and decision-making. Partner with WCH Chief of Staff and counterparts at Biogen HQ to maintain awareness of, and alignment with, corporate processes and initiatives. Lead the group in piloting and adopting WCH-specific versions of HQ processes and initiatives,...

Biogen Job Title: Development Asset Lead, Director Development About This Role: As a Development Asset Lead (DAL), you will play a pivotal role in leading the strategic development and execution of one or more preclinical or clinical stage portfolio assets within our Development team. This full-time leadership position requires you to craft and implement an integrated asset plan (IAP) that maximizes value creation and delivery. You will ensure that all functional voices are represented and that business considerations of time, risk, and value are integrated seamlessly into the planning and execution phases. This role is crucial to our business, as you will be accountable to governance mechanisms for asset-related decisions and represent the asset at portfolio governance forums. Through strategic partnership with the Program Manager, you will ensure the efficient and timely execution of the asset plan, fostering a strong team culture and maintaining alignment with our...

Biogen Job Title: Development Asset Lead, Director Development About This Role: As a Development Asset Lead (DAL), you will play a pivotal role in leading the strategic development and execution of one or more preclinical or clinical stage portfolio assets within our Development team. This full-time leadership position requires you to craft and implement an integrated asset plan (IAP) that maximizes value creation and delivery. You will ensure that all functional voices are represented and that business considerations of time, risk, and value are integrated seamlessly into the planning and execution phases. This role is crucial to our business, as you will be accountable to governance mechanisms for asset-related decisions and represent the asset at portfolio governance forums. Through strategic partnership with the Program Manager, you will ensure the efficient and timely execution of the asset plan, fostering a strong team culture and maintaining alignment with our...

Biogen About This Role Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on nights (5:45 PM - 6 AM ET) Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including - Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). Upstream / Cell Culture: Mammalian cell culture & harvest: Work in Shake flasks, WAVE bags,...

Biogen About this role The Senior Medical Manager is a part of the US Medical Nephrology team, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. As a key member of the US Medical Nephrology and reporting to the Nephrology Medical Director, the Senior Medical Manager will collaborate closely with Medical Operations to coordinate and execute the Nephrology key medical strategies and tactics. Biogen's priority is to continue to foster and enable a diverse and inclusive workforce - representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities - that reflects the communities where we operate and the patients who we serve. What You Will Do Be a credible/medical scientific expert who is accountable as the primary Nephrology medical representative and process driver that reviews and coordinates submissions for both the Commercial...

Biogen About This Role The Senior Manager, Insights & Analytics will play a critical role within the US Lupus team. You will be a proactive strategic thought partner for the US Brand team, responsible for driving actionable insights & deep understanding of the customer, overall market, and competitive landscape in both systemic and cutaneous lupus. This role plays a vital part in shaping the direction of the business and contributing to brand success. You will directly support the US Lupus brand team, focused on building foundational insights and building a go-to-market roadmap for one pipeline asset across multiple indications. You will provide critical insights for informed decisions, allowing for competitive positioning, and driving strategic initiatives based on an insights-driven approach. As a key partner to commercial and marketing leadership, you will help identify & address the most important business problems facing the franchise and help to develop...

Biogen About This Role: As the Director of Quality Control, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose (OSD) operations at RTP Pharma. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments & equipment, testing procedures. Your contributions to overall site strategy, global milestone projects, and ensuring adherence to all regulatory requirements will all be in support of our clinical and commercial supply chain. What You'll Do: Lead the Pharma Site QC Operations organization - Management of...