Clinical Supply Lead Specialist- Bulk Logistics & Quality

Biogen, Inc.

Cambridge (MA)

Ibrido

USD 89.000 - 116.000

Tempo pieno

2 giorni fa
Candidati tra i primi

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Vantaggi offerti da questo lavoro

Medical, Dental, Vision, Life ins.
Fitness & Wellness programs
Vacation and year-end shutdown time (≥

Descrizione del lavoro

Biogen, Inc. is seeking a Clinical Supply Lead Specialist in Bulk Logistics & Quality. The role spans global movement of drug substances, products, and finished goods, plus quality operations support to stay inspection-ready.

You’ll coordinate shipments, manage ERP records, and drive continuous improvements with data and AI-enabled tools. Based in Cambridge, MA or RTP, NC, this hybrid role emphasizes cross-functional collaboration, regulatory compliance, and scalable processes.

Competenze

  • Bachelor’s degree in supply chain, life sciences, engineering, business or related field.
  • At least 3 years of relevant GMP/GCP experience in pharmaceutical or clinical supply chain.
  • Experience with ERP/quality systems; willingness to learn new systems on the job.

Mansioni

  • Plan and coordinate global shipments of drug substances, products, and finished goods.
  • Manage ERP transactions and ensure system records match physical movements.
  • Handle trade compliance, including customs docs and import permits.
  • Review shipment data, investigate deviations with Quality, and drive CAPAs.
  • Manage logistics vendors and freight forwarders to keep on plan.
  • Design and document supply chain flows for new lanes and network changes.

Conoscenze

GMP/GCP knowledge
ERP systems
Microsoft 365
Analytical skills
Communication skills
Data automation mindset

Formazione

Bachelor's degree in supply chain, life sciences, engineering, business

Strumenti

Veeva
Quality systems

Descrizione del lavoro

## Clinical Supply Lead Specialist- Bulk Logistics & QualityApply: Hybrid: Cambridge, MA: Research Triangle Park, NC: Full time: Posted Today: REQ24373**About This Role:** Every clinical trial depends on investigational medicine arriving at the right place, at the right time, and in the right condition. As Clinical Supply Lead Specialist – Bulk Logistics & Quality, you will play a key role in making that happen for Biogen's clinical programs, across two areas. In Bulk Logistics, you will plan and manage the global movement of drug substance, drug product, and finished goods between manufacturing sites, contract partners, and warehouses, working closely with planners, manufacturing, quality, and logistics partners around the world. In Quality Operations, you will help keep our clinical supply operations compliant and inspection-ready, supporting quality systems, self-audits, and inspection preparation. You will own your day-to-day work independently, resolve operational issues as they come up, and act as a go-to expert for bulk logistics and quality systems, with support from experienced colleagues on new or complex topics. You will also have dedicated time to improve how we work: simplifying processes and applying data, automation, and AI-enabled tools to make work faster and smarter. This is a hybrid role to be based at our Headquarters in Cambridge, MA or at our sites in RTP, NC. **What You’ll Do:** * Plan and coordinate global shipments of drug substance, drug product, and finished goods between internal and external warehouses.* Manage shipping requests and ERP transactions so that system records match physical material movements.* Handle trade compliance for international shipments, including customs documentation, product classification, and import permits, in partnership with our Trade Compliance team.* Review shipment and temperature data, and work with Quality to resolve deviations and complete investigations and corrective actions.* Manage logistics vendors and freight forwarders, and work with external partners to keep shipments on time and on plan.* Help design and document supply chain flows for new shipping lanes and network changes, and contribute to our bulk distribution strategy.* Act as the team's expert on quality systems (e.g., Veeva), tracking change controls, deviations, and training to keep work on time and compliant.* Support clinical study self-audits, inspection preparation, and reviews of clinical material accountability.* Find ways to standardize and simplify work, and lead improvements from idea to measurable result. **Who You Are:** You take ownership of outcomes and hold a high bar for quality and compliance. You are well organized, stay calm when shipments get complicated, and enjoy solving problems that span teams, companies, and countries. You learn new areas quickly, communicate clearly, and build trusted relationships with colleagues and external partners. You have a digital mindset, readily adopting data, automation, and AI-enabled tools to enhance efficiency. **Required Skills:** * Bachelor's degree in supply chain, life sciences, engineering, business, or a related field, with at least 3 years of relevant experience in a regulated (GMP/GCP) environment, such as pharmaceutical or clinical supply chain, logistics, or quality. An equivalent combination of education and experience will be considered.* Working knowledge of GMP/GCP principles and supply chain concepts.* Experience with enterprise systems such as ERP or quality systems; specific systems can be learned on the job.* Strong organizational, analytical, and communication skills, including proficiency with Microsoft 365.* Interest in applying data, automation, or AI-enabled tools to improve ways of working.Job Level: Professional**Additional Information**The base compensation range for this role is: $89,000.00-$116,000.00Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families *physical, financial, emotional,* and *social well-being*; including, but not limited to:* Medical, Dental, Vision, & Life insurances* Fitness & Wellness programs including a fitness reimbursement* Short- and Long-Term Disability insurance* A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)* Up to 12 company paid holidays + 3 paid days off for Personal Significance* 80 hours of sick time per calendar year* Paid Maternity and Parental Leave benefit* 401(k) program participation with company matched contributions* Employee stock purchase plan* Tuition reimbursement of up to $10,000 per calendar year* Employee Resource Groups participation
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