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Clinical Supply Lead Specialist- Bulk Logistics & Quality
Biogen
Cambridge, USA
Full-time
Lead · 3+ years experience
Hybrid
Discovered 1 weeks ago
gcp
Role Overview
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.
Key Skills for This Role
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Full Job Posting
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.
- 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-$116,000.00
- Base 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.
- 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
- Why Biogen?
- We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
- At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
- All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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-$116,000.00
- Base 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
- Why Biogen?
- We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
- At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
- All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Preferred Qualifications
- 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.
Responsibilities
- 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.
About Biogen
Pharmaceuticals & Biotech5,001-10,000Founded 1978
Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
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