Senior Associate, Upstream 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 .

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.

The Role:

The Senior Associate, 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, 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.

Responsibilities:

  • Perform all manufacturing operations under cGMP/ISO requirements while displaying a proficient understanding of upstream process operations (e.g., cell culture, transfection, harvest) and a fundamental understanding of downstream operations (e.g., tangential flow filtration, chromatography)

  • Assist with the installation, commissioning, and validation of equipment within single use facility

  • Assigned to no less than one major process operation as an SME in charge of maintaining procedural guidance’s (e.g., operating procedures, work instructions, batch records) ensuring clear and compliant instructions exist for upcoming process execution

  • 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

  • Effectively leads manufacturing team in absence of appointed supervision, promoting company values and establishing the highest standards of safety within manufacturing occupied areas

  • Identify process non-conformances with a proven ability to assist with process investigations, ensuring that depictions of associated events are documented accurately and confirming corrective action proposals are an effective means for future mitigation

  • Able to contribute cross departmentally through downstream operation support assignments that fall outside of upstream responsibilities

  • 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

Required Qualifications:

  • BS / BA in Chemical/ Biological Engineering or Life Sciences with 4+ year of applicable industry experience or Associates Degree in Science with 5+ years of industry experience or H.S. diploma with 6+ years of 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

  • 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 as well as with external disciplines (e.g., Quality, Engineering, MSAT)

  • 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 the 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 Qualifications:

  • BioWork Certification or related certifications along with technical understanding of a biotech manufacturing facility are considered a plus

  • Knowledge of both cell culture and protein purification operations / 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 over head 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%)

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

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Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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