Senior Scientist, Analytical Development

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 .

Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Senior Scientist, Analytical Development opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

• Responsible for high level scientific experimental and assay development design, data analysis and final reports. Provides planning and scientific direction for interdisciplinary projects his/her specific expertise.

• This person will manage a team and work closely with R&D and CMC and GMP technical operations groups to ensure development and execution of projects according to company goals.

Essential Job Responsibilities:

• Lead a team of internal scientists and be responsible for their scientific and career development goals

• Scheduling technical staff, as appropriate, for each project

• Collaborate with upstream and downstream functions to ensure strong cross functional collaborations and integrated process and product development and characterization

• Develop assays and analytical plans to support clinical product development, product life-cycle management and associated regulatory submissions. This includes developing and implementing scientifically justifiable strategies for release/stability criteria for various scenarios including accelerated product development

• Ability to pre-qualify assays in accordance with ICH guidelines, provide reports and lead tech transfer of methods to Quality Control for qualification of assays

• Support CMC filing activities for various pre-INDs, INDs, IMPDs, and BLAs and track analytical development /QC commitments

Quantitative Dimensions:

• Effectively communicate project status, changes to plan and risks to leadership team

• Direct, motivate and hold accountable to goals and timelines all internal and external team members associated with the project

• Engages and collaborates with AIRM R&D, PST, TD, DPD and QC

Organizational Context:

This person will report directly to the Director/Associate Director of Analytical Development

Qualifications:

Required:

• D. in chemistry, biology, biochemistry, molecular biology, or related technical discipline with a minimum of 5+ years of biopharmaceutical analytical experience or Masters in a similar discipline with 8+ of the previously mentioned experience

• Excellent organizational, written, and oral communication skills to convey technical and non-technical information clearly to a diverse audience

• Ability to work productively in a collaborative and cross functional team environment within and outside of AIRM

• Significant and established experience in the biopharmaceutical industry with relevant experience in product and process characterization for cell/gene-based therapies

• Demonstrated experience and knowledge in tech transfer of methods and life cycle management

• Theoretical and hands-on knowledge and experience with methods used for molecular characterization of mammalian cells, particularly cell culture techniques, gene expression analysis, immunoassays

• Provide leadership in developing assays for various process streams, evaluating matrix effects and material storage

• Conduct testing and train analysts at the bench level, analyze data, and review results

• Keep current with advances in analytical methodologies; evaluate, assess risks, and recommend new technologies that will be useful in expanding and enhancing process and product understanding

• Collaborate with QC to transfer and/or qualify key in-process methods or release methods

• Operate under Good Documentation Practice for efficient data management and retrieval

• Generate assay development reports

• Support investigations and CAPAs as required

• Interact closely with multiple interdisciplinary groups (R&D, MFG, QA, QC, IT, Process Science Technology, Drug Product Development, Facilities, etc.)

• Proven ability to work with at a high level of integrity, accuracy, and attention to detail

Preferred:

• Advanced degree/education

• Experience in cell-based therapies and required assay development for each cell type

• Working knowledge of HPLC, flow cytometry, cell-based assays,

• Background in iPSC and hESC cell line characterization

• Strong experience/proficiency in ocular, immunomodulatory, or other disease states.

• Experience with due diligence of business development opportunities in early and late-stage programs

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

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Category CMC Technical Operations

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

EOE including Disability/Protected Veterans