Downstream Manufacturing Associate II (Mon-Thurs, 6am-4pm)

Astellas Pharma • Sanford, NC

63d • Onsite

About The Position

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 astellas . The Role: 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.

Requirements

• BS / BA in Chemical/ Biological Engineering or Life Sciences or Associates 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.

Nice To Haves

• 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

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

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 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
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level