Process Research Director jobs in Daly City, CA

Research Associate

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 and 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 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, 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.

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, make a change, and make a difference? Listed below is a current opening for a bright, driven, experienced, and just plain lovely individual who wants to join us and be a part of our journey.

The Role

Design and perform experiments of process development of the recombinant Adeno Associated Virus (rAAV) manufacturing processes at lab scale with assignments of several projects. Evaluate new technologies for process development to adapt new types of rAAV and improve drug substance quality, yield, manufacturability and efficiency. Deliver process improvements which reduce the cost of manufacturing the gene therapy pharmaceutical product, increase plant manufacturing flexibility, and throughput. This position will be located on-site our South San Francisco, CA office location.

Primary Responsibilities

• Plan experimental designs based on the knowledge of physicochemical properties of biopharmaceuticals

• Perform experiments of upstream process, cell culture, passage and transfection for rAAV production, at lab and pilot scale.

• Perform design of experiment investigations using software tools for design and data analysis using statistical software, specifically JMP or similar programs

• Regularly present data and conclusion in sub-team meetings

• Produce materials for experiments for other functions, downstream process, formulation development and analytical development.

• Conceive and evaluate new upstream process by utilizing and/or combining existing technologies within the industry

• Evaluate novel and innovative technology applicable to produce rAAV product

• Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters

• Write protocols, development reports, and other technical reports to ensure that results are properly archived and communicated.

• Proactively collaborate with consultants and internal stakeholders (Research, Process Development, Analytical Development, Manufacturing, Quality, etc.)

Required Qualifications:

• Experience in biology or engineering with 3 years relevant biopharmaceutical industry experience

• Aseptic operation skill for mammalian cell culture

• Comprehensive experiences and knowledge of development of biopharmaceuticals products

• Success independently designing and executing experiments to answer scientific questions.

• Proven ability to effectively create, communicate, and gain support for execution plans and strategies with a wide range of stakeholders

• Regularly seeks opportunities to improve existing processes and drive large-scale change that positively impacts organizational success

• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills

• Excellent and effective written, verbal communication and presentation skills

• Able to work in a fast-paced and dynamic environment with competing priorities; successfully drive projects forward to meet program/project deliverables

• Outstanding collaboration, problem solving team player with excellent communication and organizational skills

• Positive, professional attitude with a passion for science; operates with transparency; is trusted

Preferred

• Prior rAAV gene therapy experience

• Knowledge of down-stream purification, like filtration, chromatography (HPLC, UPLC, using Akta) and TFF

• Experience with DOE and statistical analysis via JMP or comparable software

Quantitative Dimensions:

This role is linked to improving manufacturing processes, reducing COGs and enhancing quality by utilizing new ideas and innovations based on science. The position includes working on early-stage products to provide procedures and materials to drive stage-up and clinical evaluation of portfolio products. The position also provides data and materials that support regulatory filings up to BLA licensing activities.

Organizational Context:

This position reports to the Associate Director of Process Science. The Associate Director of Process Science reports to the Senior Director of Process Science.

Working Conditions:

On-site (South San Francisco in the US)

Salary Range:

• $72,800 – 97,000 NOTE: Final salary could be more or less, based on experience)

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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Category Gene Therapy Research & Technical Operations

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

EOE including Disability/Protected Veterans