Non-Clinical Bioanalytics Writer_

**Nonclinical Scientific Writer-Bioanalytics**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:**In this role as a nonclinical Bioanalytics writer in Astellas Gene Therapy (AGT) group, you will perform supporting the Bioanalytical team and producing method and analysis reports. You will be the specialist for the Bioanalytics team for interpreting data, transcribing methods, results, and driving discussions with stakeholders. Experience in writing gene therapy nonclinical documents such as pre-IND briefing documents, nonclinical sections of an IND/BLA/IB and other regulatory documents is highly favorable.**Responsibilities:**Primary role - Performing nonclinical writing tasks, such as:+ Experience in deadline driven bioanalytical environments that support preclinical GLP and non GLP studies.+ Experience writing bioanalytical reports for molecular and immunological assays such as PCR and ELISA.+ Experience with incorporating animal study protocol information, COAs etc. into bioanalytical reports.+ Extensive experience with data QC using spreadsheet tools.+ Experienced in reviewing data in various formats and adapting data to fit specified templates.+ Up-to-date knowledge of regulatory expectations for bioanalytical reporting.+ Experience with data compilation and QC from multiple spreadsheets as well as basic statistical representations of data (i.e., mean/stdev/n etc.)+ Good understanding of ICH guidelines for drafting bioanalytical reports, assay validation protocols for supporting gene therapy programs.**Required Qualifications:**+ Master’s degree with relevant experience; PhD degree preferred.+ 3-4 years’ experience as nonclinical writer in bioanalytical setting.+ Experience in writing biologics, preferred AAV gene therapy related nonclinical documents.+ Pharmaceutical industry understanding.+ Excellent understanding of ICH guidelines for bioanalytical method validation procedures for biologics and gene therapy programs.+ Excellent communication and presentation skills.+ Experience with a broad range of different nonclinical and research writing tasks.+ Established record of being a proactive team-player and able to deliver on time and with high quality.**Preferred Qualifications:**+ Prior experience in generating bioanalytical study reports supporting nonclinical GLP studies with emphasis on gene therapy programs.+ Prior experience in supporting IND filings and interacting with internal and external regulatory agencies.**Working Environment:**At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.**Salary Range** **:** $101,300 - $135,000 (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._\#LI-TR1Category GT - Integrative BiologyAstellas is committed to equality of opportunity in all aspects of employment.EOE including Disability/Protected Veterans