Manufacturing Associate II, Downstream Manufacturing

Manufacturing Associate II, Downstream Manufacturing

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 Associate II, Downstream Manufacturing, will be a key contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and will provide overall manufacturing operations support that includes yet is not limited to; equipment testing, SOP/batch record generation, and validation protocol execution support. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.

Role and Responsibilities

• Perform all manufacturing operations under cGMP/ISO requirements
• Display understanding of Downstream process theory (e.g., tangential flow filtration, chromatography) equipment operation, and aseptic processing
• Assist with the installation, commissioning, and validation of equipment within single use facility
• Adhere to manufacturing procedures and documentation as well as identifying clarifications or updates when required
• Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process
• Maintain a high level of quality and compliance with regards to all aspects of manufacturing
• Assist/write SOPs (standard operating procedures), batch records, and other GMP documentation
• Display ability to identify and escalate potential GMP issues, as required
• Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules
• Assist in the evaluation and incorporation of new technologies

Quantitative Dimensions

The Associate II, Downstream Manufacturing, will contribute to manufacturing readiness and operational output. The role is responsible for executing a combination of engineering and GMP Clinical batches, along with building a diverse and technically strong team.

Organizational Context:

The Associate II, Downstream Manufacturing, will typically report to the Supervisor or Sr Supervisor, Manufacturing.  This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Qualifications:

Required Qualifications

• BS / BA in Chemical/ Biological Engineering or Life Sciences or Associate’s degree in science or related field with 1 years of industry experience or H.S. diploma with 2 industry experience
• Experience in maintaining detailed records and ability to assist in document revisions
• Understanding of cGMPS as related to commercial and clinical operations
• Strong communicator with ability to work effectively both independently and as part of a team
• Developing problem-solving skills
• Strong computer skills including MS Office (Word, Excel) and proven ability to establish and maintain effective working relationships with team members and managers
• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
• Will support and demonstrate quality standards to ensure data of highest quality and will be expected to perform other duties and/or special projects, as assigned

Preferred Qualifications

• BioWork Certification or related type certifications are a plus along with technical understanding of a biotech manufacturing facility
• Knowledge of protein purification and technique
• Experience with single-use technologies
• Understanding of FDA regulations
• Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency
• Ability to clearly define events and associated process conditions during nonconformance or safety escalation efforts
• Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities

Location and Working Environment

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching overhead activities, and independent mobility to lift to 25lbs
• This is an on-site role working in a cGMP regulated manufacturing facility
• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
• Must be able to work onsite, Mon-Thurs schedule, 6am - 4pm ET)

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

$32.38 - $46.25 (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

#LI-TR1

Salary : $32 - $46