求人名 Formulation Development Scientist (Scientist II) - Gene Therapy Drug Product
勤務地 Tsukuba, Ibaraki
事業部 Cell and Gene Therapy Research
雇用形態 正社員
仕事内容
【募集の背景 / Purpose & Scope】
The primary purposes of the Scientist II, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV (recombinant Adeno-Associated Virus) drug product under development, supporting the growing and diversifying portfolio of programs within Astellas’ pipeline.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
•Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use.
•Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites.
•Author regulatory documents such as IND and briefing documents for meetings with healthcare agencies.; prepare responses to Information Requests from agencies.
•For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data.
•Evaluate new medical devices or container-closures for local injection products
•Lead the technical discussion cross-functional/divisional to align and enable efficient drug development work
•Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately
•Participate the program meetings to achieve key milestones in a timely manner
•Regularly present data and conclusions in sub-team meetings
•Occasionally presents technology summaries to management and program teams
（変更の範囲）
会社内での全ての業務
【就業環境に関する要件 / Specific Physical or Environmental Requirements】
•This position is based in Japan or US and will require on-site work.
【応募要件 / Qualifications】
＜必須 / Required＞
•Advanced degree in biology or engineering with 8+ years of relevant experience in the biopharmaceutical industry
•Experience in formulation development for biopharmaceutical products
•Experience in authoring IND, BLA or other related regulatory filings, and responding to agency feedback/inquiries
•Proven and successful history of taking direction and working independently in a fast-paced environment
•Positive, professional attitude with a passion for science
•Outstanding collaboration and problem-solving skills; team player with excellent communication and organizational abilities
•Business-level proficiency in English
＜歓迎 / Preferred＞
•Experience with process development and technology transfer to GMP facilities for drug product manufacturing process
•Experience with preparation activities for PPQ of drug product manufacturing processes.
•Experience in the development of packaging process and transportation validation for drug products
•Experience in operating basic analytical tools, such as chromatography and electrophoresis
•Experience working with external vendors, institutions, and other collaborators to develop new and innovative technologies
•Experience with handling rAAV gene therapy vectors or other viral particles
【応募書類 / Application Documents】
和文履歴書（必須）・和文職務経歴書（必須）・英文レジュメ（任意）
Resumes
【選考プロセス / Selection details】
書類選考 → 1次面接 → 最終面接
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → Final interview
*Please be advised that there might be a change in the process.
【勤務地 / Location】
（雇入れ直後）
茨城県つくば市 アステラス製薬 つくば研究センター
Tsukuba, Ibaraki
※ＪＲひたち野うしく駅とつくばエクスプレス（TX) 研究学園駅より通勤バスがございます。
（変更の範囲）
会社の定める事業場および自宅
【勤務開始日 / Start Date】
応相談
Will be decided according to the candidate's flexibility
【契約期間 / Contract Duration】
期間の定めなし
Not limited to specified period
【試用期間 / Probation Period】
試用期間原則なし
No probation period in principle
【給与 / Salary】
①基本給：当人の経歴・技術・技能等を考慮して決定
②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給
③フレックスタイム制の場合：月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade)
③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【昇給 / Salary Raise】
有り
【賞与 / Bonus】
有り
【諸手当 / Allowance】
裁量労働手当、住宅手当、通勤手当 等
Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours】
8:30～17:30（月～木）、8:30～15:45（金）、専門業務型 裁量労働制
裁量労働制の場合、所定労働時間を働いたものとみなす。
8:30～17:30（Mon～Thu）、8:30～15:45（Fri）
Discretionary Work System
【休日 / Holidays】
完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
【休暇 / Vacation Leave】
年次有給休暇、育児休業制度、介護休業制度 等
Annual paid leave, childcare leave system, nursing care leave system, etc.
【福利厚生 / Welfare】
雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
【アステラス製薬 採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.
"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."