About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.
Our Values:
Be BOLD (Find a Way)
Care Deeply -- for our patients, each other and our work
#GSD (Get Stuff Done)THE ROLE
The Associate II, Upstream 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.
Essential Job Responsibilities
Perform all manufacturing operations under cGMP/ISO requirements
Display understanding of Upstream process theory (e.g., incubation, expansion, cell growth, harvest) 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
Qualifications
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
Preferred
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
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
Referral bonus program
#LI-TR1
Category Gene Therapy Research & Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans