8 project manager jobs found

Biogen About This Role: As a Senior Category Manager for Direct Materials, you will play a pivotal role in optimizing and innovating key categories crucial to Biogen's operational footprint. Reporting to the Associate Director of Global Strategic Sourcing, this position sits on the Global Strategic Sourcing team, focusing on the direct material space for internal manufacturing operations, including categories like chemicals, filters, and resins. You will be responsible for managing category strategies and sourcing initiatives across various modalities, such as Biologics, Oral Solid Dosage, Parenteral filling, ASOs, and Clinical Label & Packaging. This Senior Manager will ensure the needs of the business are met by leading category management, sourcing strategies, and sourcing process from defining business needs, knowledge of supply marketplace, executing RFx events, lead contract negotiations, supply risk management, and supplier relationship management. What You'll...

Biogen About This Role As a member of Manufacturing Sciences within the Parenteral Filling area, the Sr. Engineer II will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Pharma Site. The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging. What You'll Do Provide technical expertise to the clinical stage, PPQ, and commercial manufacturing campaigns run at the site. Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed. Provide technical and operational guidance to Manufacturing during GMP campaigns Lead technical investigations towards process impact assessments and ensure timely completion and communication Author Manufacturing and Process Performance Qualification validation protocols and...

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 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: 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...

Biogen About This Role As a Senior Associate I, Quality Control (QC), you will play a critical role in ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release. What You'll Do Perform and review analytical testing for product release, stability studies, and method validation. Lead method transfer and qualification activities. Author protocols, technical reports, and change controls. Mentor peers and contribute to cross-functional process improvement initiatives. Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations). Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed. Evaluate the impact of QC activities on project teams, including implications for batch release and stability data. Support setting and reporting of measurable goals, targets,...

Biogen About this Role In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset. What You'll Do Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records management and project execution -participate in projects (simple to moderately complex in nature), facilitating timely execution. Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production...

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...