Biosample Operations Manager

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope:

The primary purpose of the Biosample Operations Manager is to initiate and execute biosample management activities. The position includes vendor management, training and effective interactions with study teams, process development and improvement, Biosample operations system administration and sample tracking activities.  Responsibilities to be performed independently, and in collaboration with peer BOMs, Lead and Department Head.

Role and Responsibilities:

The Biosample Operations Manager (BOM) is responsible for all operational activities associated with the implementation and maintenance of studies in the sample management system and to act as a resource for best practices for biosample management.

The following key activities are the Sample Management responsibilities of the BOM, but other duties as assigned or special projects as needed:

Sample Management System:

• Manages and coordinates study set up in Sample Management system
• Acts as liaison between study team, Sample Management vendor and Biosample vendors
• Monitors study build and rollout according to timelines.
• Ensures system training is conducted and support study team usage.
• Contributes to ongoing team forum by providing feedback on lessons learned, discuss challenges and changes etc.
• Collects and maintains completed lessons learned and evaluation documents for consolidated review

Process Development, Improvement and Maintenance:

• Supports the maintenance of any associated quality documents relative to Biosample management to ensure they are kept current and accurate.
• Supports the maintenance of the Biosample Operations Work Instructions and Templates.
• Participates in vendor evaluation as required (e.g., new technologies, clinical CRO selection).
• May contribute to various Medical & Development process improvement initiatives and SOP (or other quality document) development.

Training and Communication:

• Identifies any training needs and participates in the development of any sustainable training materials required.
• Supports the ongoing review of training materials to ensure they are current, accurately reflect the appropriate BSMO processes and are appropriately deployed to the affected departments and job functions.
• Maintains the BSMO SharePoint site.

Required Qualifications:

• Bachelor's degree (or equivalent) with scientific or clinical background, study management experience preferred
• 2 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 1 years’ experience as clinical study manager, central laboratory project manager, data manager, or project manager.
• Working knowledge of GCP, FDA and/or EU Clinical Trials Directive guidance documents
• Experience with protocol and clinical drug development processes
• Proven project management skills and leadership ability
• Excellent interpersonal, written, and verbal communication skills and computer ability

Preferred Qualifications:

• Experience with Biosample Tracking/Management preferred.
• Ability to integrate and apply GCP, clinical operations, and scientific knowledge in the planning, management, data review, and reporting (as applicable) of Biosample related data.
• Ability to read and understand clinical protocols and related documents, especially with regard to collection, processing, storage, and shipment of critical specimens (e.g., PK, PD, Biomarker, PGx, etc.) in accordance with the protocol, clinical operations manual, and laboratory manuals
• Problem solving, critical thinking skills (i.e., Can Identify root cause and propose/implement reasonable corrective actions in the context of region-appropriate GCP regulations and guidance, Astellas SOPs, protocol, and industry best practices; Able to apply lessons learned from prior experience to novel challenges).
• Proactive thinking skills (i.e., Can anticipate problems and take appropriate actions to avoid them).
• Highly motivated, self-directed (i.e., Ability to work independently); Follow through on commitments.
• Competent presentation skills (i.e., verbal and visual presentations are logical, organized, accurate and understandable.)
• Excellent writing skills (i.e., concise, accurate, unambiguous style without typos and grammatical errors.)
• Excellent oral communication skills (i.e., can describe experiences and issues clearly and concisely and then if necessary, provide details.)
• Highly Organized (i.e., Aware of status of tasks/milestones of assigned projects and of delegated tasks)

Location and Working Environment

This position is based in Northbrook, Illinois.  Remote work from anywhere in the US is available.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

What awaits you at Astellas?

Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.  Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency.  We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$111,300 - $159,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

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