Stability Specialist II BioPharma Manufacturing US Method & Tech Transfer

Stability Specialist II - US Method and Tech Transfer

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 Specialist II Biopharma Manufacturing US Method and Tech Transfer will be responsible for support of the Quality Control stability program, organization of stability studies, document management and revision, contract test lab management, and as appropriate, lead of laboratory investigations in support of pre-clinical, clinical, and commercial viral vector products in compliance with cGMP requirements.

*This role is hybrid, with the expectation to be onsite 3-days/week in Sanford, NC.  

Role and Responsibilities

• Initiate new stability study configuration documents; perform stability document revisions and document management; stability protocols and reports (interim/final)
• Assist with the stability schedule
• Responsible for contract testing lab (CTL) schedules
• Interact with Analytical Development, CTLs, Site QC teams to ensure timely testing of samples according to protocol
• Provide feedback on design and workflow of stability modules in LIMs
• Serve as the single point of contact between Astellas and CTLs to review protocols and reports, routine testing data, and investigations
• Initiate works orders and purchase orders for contract lab testing, as needed
• Responsible for the management of the stability data: collect and review stability data and create/update stability tables using templates
• Assist with trending of stability data
• Lead or participate in CTL and stability deviations: invalid results, unexpected results, OOS/OOT, lab investigations, and contract lab discrepancies
• Author and manage change controls
• Statistical analysis support using JMP or other statistical software.
• Assist in the preparation and review of CMC regulatory submissions
• Ensure compliance with applicable cGMP regulations, ICH guidelines, and SOPs, and support regulatory audits

Required Qualifications

• B.S. Degree in biological sciences, cell biology, chemistry, or related field with 5+ years of laboratory or stability experience in a GMP environment or a Masters in Biological Sciences, Cell Biology, Chemistry, or related field with 2+ years of laboratory experience.
• Experience with laboratory or stability deviations, investigations and/or discrepancies
• Experience with contract lab management
• Experience with Veeva or other EDMS
• Experience with statistical software (JMP)
• Good to excellent technical writing skills and verbal communication skills
• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
• Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment.
• Highly self-motivated and goal oriented

Preferred Qualifications

• Knowledge of Good Document Practices (GDP)
• Experience with LIMS
• Demonstrated proficiency in Microsoft Office suite

Location and Working Environment

• 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.
• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%).

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

$94,570-135,100 (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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