Astellas Jobs (2)

Pilot Plant Associate I

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)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference?

Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Reporting to the Pilot Plant Manager, the Pilot Plant Associate will participate in upstream and downstream areas of AAV development in the Pilot Plant for new gene therapy programs and processes.

This position will be located in South San Francisco, CA.

Responsibilities

• Perform all operations as directed per internal policies and other requirements.
• Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in the process
• Maintain a high level of attention to detail with regards to all aspects of manufacturing execution
• Operate production equipment, including inspection, set up, processing, and cleaning
• Execute corrective measures addressing any issues in a timely manner
• Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues.

Execute corrective measures addressing any issues in a timely manner

• Ability to contribute to process improvement plans and help drive to completion
• Conduct operations in a collaborative, team environment with a positive attitude to accomplish goals
• Available to work outside of normal business hours and / or overtime as required
• Assist with process development experiments following defined experimental plans for non-GMP supply
• Assist in the evaluation and incorporation of new technologies
• Other duties as assigned

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 .

This position is based in Alameda, California. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Candidates interested in remote work are encouraged to apply.

About Us :

iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics.

Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.

iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc.

a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families.

iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases.

At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic.

Purpose and Scope :

As a critical member of the iota organization, the Medical Development and Safety Officer (MDSO) will support iota’s oncology program.

The role leverages deep therapeutic area expertise and experience in the field of clinical oncology and helps the organization develop and sustain safe devices and services by offering a clear articulation of patient risk and safety in a comprehensive and dynamic manner throughout the device lifecycle.

The MDSO augments medical judgment with both qualitative and quantitative application of scientific and medical analysis to promote patient safety, balance risk with benefit, guide strategy, and drive innovation.

This is a key medical role which provides leadership through influence across the organization and carries responsibility for ensuring that rigorous, proactive and reactive medical safety input is provided across all areas of the business.

Essential Job Responsibilities :

• Provides medical expertise and assessment to support patient safety throughout the product lifecycle, including product development processes, risk management, clinical trials, post-market surveillance, and field actions.
• Provides a clear and accountable point of escalation of observations of risk to patient safety to iota Biosciences senior leadership.
• Exhibits the highest levels of ethics and accountability and acts as a key advocate for the patients and a function of medical safety to engage internal and external stakeholders in matters of medical device safety.
• Provides specialized therapeutic area medical expertise throughout the device life cycle, including medical input into risk management, product complaints, vigilance reports, health risk assessments, field safety communications, and serves as a medical advisor for regulatory issues and in the creation of instructional material / labeling to ensure safe use of medical devices.
• Provides direct medical input into clinical risk trending and safety signal detection, assessment, management and reporting.

Liaises with clinical field personnel and HCPs when needed to assist in the assessment of significant adverse events. Advises on failure investigations and provides medical opinion in assessing health hazards posed by devices.

Implements experience-based understanding of medical risk and benefit to arrive at objective assessments of health risk.

Undertakes periodic review of the state of the art in medical practice and the competitive landscape, with a focus on determining whether any adverse or mitigating safety signals can be assessed.

This may include review of medical literature, clinical trial data, etc.

• Provides independent review and approval (and occasionally authorship) of a range of clinical, scientific and safety documents and reports used for safety and performance assessment in various quality, risk management, clinical evidence processes, post-market surveillance and regulatory submission.
• Contributes to internal development and assessment of novel technologies and provides medical safety evaluation in new business development activities.
• Engages compliantly on behalf of iota Biosciences in external interactions with study investigators, regulatory bodies, KOLs, professional societies and advisory boards on matters of medical safety.

Interacts with independent committees ensuring exchange of information with these committees is transparent and adequate to meet objectives of safety oversight.

• Provides oversight and guidance to the development, training and mentorship of medical and non-medical personnel working on the device program who have safety-focused or adjacent roles.