Associate III, Downstream Manufacturing

Associate III, Downstream Manufacturing

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

Purpose and Scope:

The Associate III, 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, validation protocol execution support, as well as cross site tech transfer collaboration. 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.

Essential Job Responsibilities:

• Perform all manufacturing operations under cGMP/ISO requirements while displaying a proficient 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 GMP documentation guidance (e.g., standard operating procedures) with a proven ability to identify clarifications / updates as well as assist with document updates / generation when required
• Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process and maintain a high level of quality and compliance with regards to all aspects of manufacturing in both personal actions as well as through the training of other manufacturing associates
• Ability to identify and escalate process non-conformances based on process guidance documents, specified operating limits, and performance metrics tracking
• Able to contribute cross departmentally through upstream operation support assignments that fall outside of downstream responsibilities
• Often assigned in a support role to internal and cross-functional project teams
• Lead the completion of routine non-process operations including, but not limited to, preventative maintenance work order execution and safety walkthrough audits
• Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules

Quantitative Dimensions:

The Associate III, 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 III, 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:

• BS / BA in Chemical/ Biological Engineering or Life Sciences with 2+ year of applicable industry experience or associate’s degree in science with 3+ years of industry experience or H.S. diploma with 4+ years of industry experience
• Understanding of cGMPS as related to commercial and clinical operations
• Experience in maintaining detailed records and ability to assist in document revisions
• Strong communicator with ability to work effectively both independently and as part of a team along with effective problem-solving skills
• Strong computer skills including MS Office (Word, Excel)
• 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
• Strong communicator with the ability to work independently and closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work
• Will be expected to perform other duties and/or special projects, as assigned

Preferred:

• BioWork Certification or related certification along with technical understanding of a biotech manufacturing facility is a plus
• Proficient understanding of protein purification and technique
• Experienced in Startup of a new facility
• 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 support general investigations and CAPA execution
• 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

Working Conditions:

• 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%)
• Work Schedule: Mon-Thurs. 6am - 4pm.

Salary Range: $35.00 - 55.00 (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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