Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Associate Director of Regulatory CMC will lead and execute related chemistry, manufacturing and controls (CMC) regulatory activities/interactions under overall direction of Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, and will help to develop regional regulatory CMC strategies for both established products and development products , serving as a key operational interface with global and regional teams.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Contribute to the development and execution of the CMC regulatory strategies and lead day-to-day management of related regulatory activities for assigned programs. Under the guidance of the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, work with global and regional teams to develop and maintain project plans and timelines for pipeline of products, including coordination and support of global regulatory CMC submissions.  
2. Provide functional supervision and guidance to team members to ensure that all reporting requirements and other commitments are met with respect to Clinical Trial Notifications (CTN), NDAs, PCAs, MCNs, etc. while escalating issues and risks to the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, as appropriate. 
3. Provide regulatory advice and support for the global regulatory compliance of Ultragenyx pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation, with escalation of key risks and issues to the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC as appropriate. 
4. Coordinate the preparation, review and filing of CMC sections of regulatory submissions and support interactions with regional regulatory agencies. 
5. Coordinate and oversee the preparation of regulatory CMC submission documentation to ensure that it is prepared with appropriate quality and within agreed timelines, in order to meet regional regulatory requirements and corporate objectives. 
6. Maintain and manage a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations, and prepare, generate and communicate status reports and other communication to the organization. 
7. Provide strategic and technical CMC regulatory support, guidance and expertise, and serve as the Regulatory Affairs Japan point of contact for CMC matters to global and cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, Manufacturing, contract organizations and consultants. Ensure, in alignment with the global regulatory strategy and under the guidance of the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, that all applicable regulatory requirements/options and associated risks are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.  
8. Provide guidance and advice on regulatory CMC environments; provide assessment of the impact of new and changing regulations/requirements.  

Requirements:

1. BA/BS in a scientific field of study with 8 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry. 
2. Strong knowledge, experience and the ability to provide technical guidance in interpretation of regulations and guidelines related to biological drugs and regenerative medicinal products development. 
3. Proven ability to analyze and organize information logically. 
4. Sound understanding and practical application of industry standards and international regulations and guidelines.  
5. Experience in clearly and effectively communicating regulatory strategies, submission documents and plans both internally and externally. 
6. The ability to effectively coordinate, manage and prioritize multiple projects in a fast-paced, deadline driven start-up environment.  
7. Strong collaboration, teamwork, organizational skills at attention to detail 
8. Excellent written and verbal English and Japanese communication skills. 

#LI-CK1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Associate Director of Regulatory CMC – Japan は、Head of Regulatory Affairs Japan 及び／あるいはGlobal Regulatory CMCの指示に基づいて、化学、製造および管理（CMC）に関連する薬事業務および当局対応をリードし実行する。グローバルチームおよび地域チームとの主要な業務インターフェースとしての役割を果たしながら、既存製品および開発製品の双方について、地域の薬事CMC戦略の策定を支援します。 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. 担当プログラムにおける CMC 薬事戦略の立案及び実行に貢献し、関連する薬事業務の日常的な推進を主導します。グローバルおよび地域チームと連携し、製品パイプラインのプロジェクト計画およびタイムラインを策定・維持するとともに、グローバルの薬事CMC申請の調整および実務的な支援を行います。 
2. Clinical Trial Notifications（CTN）、新薬承認申請（NDA）、承認事項一部変更承認申請（PCA）、軽微変更届（MCN）などに関する報告要件およびその他のコミットメントがすべて満たされるよう、他のメンバーに対して機能的な指導・管理を行い、指導・管理を行い、必要に応じて課題やリスクをHead of Regulatory Affairs Japan 及び／あるいはVP, Global Regulatory CMCにエスカレーションします。 
3. Ultragenyx の製品パイプラインに関するグローバル薬事コンプライアンスについて、助言および実務的な支援を提供し、CMC 関連の変更管理の評価、プロセスおよび製品の同等性に関する戦略的評価、それらの規制上の影響評価および対応の実行支援を行います。重要なリスクや課題については、適切に Head of Regulatory Affairs Japan 及び／あるいはVP, Global Regulatory CMCへエスカレーションします。 
4. 規制当局への申請に必要なCMC関連文書の作成、レビューおよび提出を調整し、地域の規制当局との対応を実務的に支援します。 
5. 地域の規制要件および企業目標を満たすため、CMC関連の薬事申請文書が適切な品質を確保し、合意された期限内に準備されるよう、管理調整を行います。 
6. CMC薬事コミットメントおよび当局への報告義務の状況を追跡・監視するための集中した文書管理を維持・管理するとともに、定められたプロセスに従い、状況報告やその他の情報を作成・発信し、関連組織に共有します。 
7. 製剤開発、品質保証（QA）、品質管理（QC）、製造、外部委託機関やコンサルタントなど、グローバルおよび各機能横断チームに対し、CMC薬事に関する戦略的かつ技術的なサポート、指針および専門知識を提供し、CMC領域におけるRegulatory Affairs Japan の窓口として対応します。また、グローバル薬事戦略に整合し、Head of Regulatory Affairs Japan 及び／あるいはVP, Global Regulatory CMCのガイダンスのもと、適用される規制要件や選択肢、および関連リスクを十分に考慮したうえで開発プログラムに適切に反映し、製品が適切な規制やガイドラインに準拠して開発・製造されるよう確保します。 
8. CMC の規制環境に関して指針や助言を提供し、新しい規制や要件の変更が与える影響を評価します。

Requirements:

1. 科学系分野の学士号（BA/BS）を取得しており、製薬・バイオテク業界における薬事関連業務で 8年以上の実務経験 を有すること。 
2. バイオ医薬品および再生医療等製品の開発に関する規制・ガイドラインの解釈について、高度な知識・経験を有し、技術的な指針や助言を提供できる能力を持つこと。 
3. 情報を論理的に分析し、体系的に整理できる能力を有すること。 
4. 産業基準および国際的な規制・ガイドラインについて、十分な理解を有し、実務に適切に適用できること。 
5. 規制戦略、申請文書、計画内容を社内外の関係者に分かりやすく、効果的に伝えた経験があること。 
6. 迅速で期限重視のスタートアップ環境において、複数プロジェクトを効果的に調整・管理し、適切に優先順位をつけて遂行できる能力 を有すること。 
7. 高い協働性、チームワーク、組織力、および細部への注意力を有すること。 
8. 優れた英語および日本語の文書・口頭コミュニケーション能力 を有すること。 

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director, Regional Supply Chain Management for Japan acts as the representative for Global Supply Chain Management for all matters relating to the Japan region. This position focusses on building, implementing and executing the regional supply planning and distribution strategy in alignment with overall regional business strategy. The role oversees the distribution network and operations, regional demand, supply, operations and inventory planning, as well as ensuring successful product in-market product launches. 

This highly matrixed role closely liaises with many global and regional functions (Sales & Commercial, Packaging, Supply Planning, Medical Affairs, Clinical Operations, Quality, Finance and Tax), and represents the global supply chain in all Japan regional matters. This position also ensures compliance of the supply operations with local / regional regulations and global standards. 

The role may also act as a liaison between the local Japan management team and the wider Technical Operations group in the Japan region – including Global Packaging Operations and Global Product Supply.   

This position is a member of the Global Supply Chain leadership team and is located in Tokyo, Japan.  

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. As the Japan region grows, support all supply related activities in the region. Represent supply chain on the regional commercial management team.  
2. Build and oversee a reliable supply network in Japan for commercial distribution and support local clinical distribution activities including new product launch readiness as needed. 
3. Manage all local supply chain related activities including, but not limited to, order management, transportation, warehousing, inventory management and reporting, logistics and trade (import / export), and ERP transactions for Japanese product. 
4. Own the business relationship with all in country third party logistics providers. 
5. Alongside the local commercial team, oversee the regional Sales Inventory and Operations Planning (SIOP) for commercial launches, marketed products, early access programs and investigator sponsored trials. 
6. Develop annual budget plans and ensure supply chain costs in the region align with financial goals. Identify opportunities for supply chain related cost savings and implement solutions. 
7. Ensure compliance with regional regulations, GDP guidance, trade compliance and tax compliance in all areas of the regional supply chains 
8. Support for order processing operations from and to the wholesaler. 

Requirements:

1. Language: Fluency in both Japanese and English is required, both written and spoken, as well as understanding of local business norms in both countries. 
2. Education: A bachelor’s degree or local equivalent in a related field (Supply Chain, Business, Engineering). A master’s degree in business administration (MBA) is strongly preferred. 
3. Management experience: 8 or more years of experience in Supply Chain / Technical Operations in the pharmaceutical or biotech industries. Strong preference for project management and pharmaceutical launch experience as well as a certificate in Lean / Six-sigma training (green belt or higher). 
4. Pharmaceutical and regulatory experience: Understanding of pharmaceutical industry procedures and regulations including GxP and other regulatory requirements – particularly as it pertains to the local Japan market. Experience with new product introductions as it pertains to supply chain is preferred. 
5. Quality acumen: Familiarity with local and harmonized quality standards as they pertain to finished products and distribution. Experience operating in a pharmaceutical or biotechnology quality system and its related components (deviation, change control, etc…)    
6. Financial acumen and compliance: Understanding of regional and global commercial implications including SOX, tax regulations, international trade rules and trade compliance. 
7. Information technology: Hands on experience with the implementation and / or operation of a scalable enterprise resource system (ERP) such as Oracle, SAP or similar system. 
8. Travel: Ability and willingness to travel throughout Japan as needed as well as internationally (estimated four times per year), including travel to California. 

#LI-CK1  #LI-Hybrid

At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.

We are seeking an experienced Technical Sales Specialist for the APJ distributor countries who will play a pivotal role in establishing and executing strategies for obtaining new customers and maintaining/growing existing APJ distributor markets to meet and exceed revenue goals. This is an incredible opportunity for someone who has a strong desire to “win” and build customer relationships. The Technical Sales Specialist will have strong technical knowledge in the spatial field and will demonstrate technical credibility to effectively consult with customers and distributors to influence key decisions on technology and product choices. Strong business acumen is required to build successful account and territory plans and translate territory strategy into business results. This role will report to the Director of Sales - APJ and will be a remote role.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

Essential Functions and Responsibilities:

• Provide expert understanding and strong technical competency in discussing Element Biosciences’ capabilities and product offerings with selected pharmaceutical, biotechnology, and other related companies and government institutes
• Establishes and executes on strategies for obtaining new customers and maintains/grows existing customer accounts in order to meet and exceed revenue goals
• Takes an analytical approach towards executing optimal solutions for an issue or opportunity
• Demonstrates capability to present versatile and unique solutions during customer negotiations in order to establish mutually beneficial circumstances for the customer and Element
• Has the ability to learn, change, and gain from each experience to become more effective in subsequent sales scenarios
• Works effectively in a team environment to drive and create revenue opportunities
• Manages customer relationships pre-sale, including a strategy to develop long term business relationships
• Possesses a deep understanding of multi-omic (NGS, Spatial, Cytometry etc.) applications and preferably brings a strong network within Biotech and Pharma
• Coordinates and communicates strategic business plans effectively to the team
• Design various strategic plan to improve sales and marketing plans in APJ distributor markets
• Responsible for ensuring that Element Biosciences’ commitment to customer satisfaction is performed, delivered, and constantly improved
• Interacts and engages with other departments (e.g., Marketing, Customer Services) and local sales team & staff to ensure coordination of activities and alignment on common goals
• Responsible for ensuring Salesforce.com (SFDC) is completely utilized, updated, and compliant with company policies and practices

Education and Experience:

• PhD degree is required, preferably in Biology / Genetics or Ph.D. in Biology / Genetics preferred
• 3+ years of experience of commercial (sales/marketing/business development) experience or equivalent experience within a laboratory setting plus customer facing experience
• Strong Genetics and Molecular Biology foundation. Preferred knowledge of Next Generation Sequencing, Genotyping method, Spatial and Cytometry
• Deep knowledge and relationships with decision makers/influencers and leading researchers in Biotech and Pharma
• Experience with strategic sales skills with proven ability to develop and grow key accounts is preferred
• Conducts presentations effectively, professionally and comfortably to customers/peers/management
• Strong desire to “win” and build customer relationships
• Fluent in English, additional Asian languages are great to have

Physical Requirements:

• Extensive local and regional travel (50-70% time) to work in the field with APJ distributors, attend meetings with key customers and participate in trade shows
• Frequently moves boxes weighing up to 20 pounds

Location:

• Remote/APJ

Travel: 

• Domestic and International travel up to 50%

Job Type:

• Full-time/Exempt

Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience. 

We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Position: Sales Account Manager

Location: Tokyo, Japan

Report to: Head of Sales, Japan

Role Description:

The Sales Account Manager (SAM) is responsible for implementing sales and marketing strategies and tactics for related product/service lines to achieve sales and profit goals in their designated geographic territory. The SAM is expected to use his/her knowledge of the business and external contact to expand and deliver profitable initiatives to the organization.

Key Responsibilities:

• Achieve the agreed monthly/quarterly/yearly sales and/or profit goals.
• Contribute to the development and implementation of sales strategies and tactics for products/services, new markets and new applications.
• Work together with Sales/BD Managers and Technical Account Managers to ensure all possible actions are taken to secure business in competitive situations.
• Share market knowledge and customer feedback with Senior Management, Sales and Marketing teams.
• Report timely to Head of Business Development including：Written reports as requested; Documentation of sales activities via CRM system (Sales Account Manager (SAM) will be responsible for implementing sales and marketing strategy and tactics for related product/service lines to achieve sales and profit goals in their designated geographic territory).
• Introduce GenScript to new markets – Industrial/Academic/Government institutions.
• Drive business expansion in collaboration with inside technical support team (TAM).
• Build a business reference network for business expansion.
• Work through channel partners and key customers to achieve the sales targets

Qualifications:

• Masters or PhD. in Biology / Life Science discipline
• At least 1 year of hands-on lab experience preferred; Life science research, molecular biology or related research experience is a plus)
• At least 2 years of relevant sales experience preferred with a high level of technical and professional expertise. Field application scientist experience may be acceptable.
• Knowledge of the Biological and CRO market with an emphasis on one or more of the following: Gene Synthesis, Protein, Peptide, BioAssay, Antibody or Cell Line, Products, and
• Socially active within the network of the life science industry.
• Ability to communicate effectively in English, verbally and in writing.
• Ability to work independently or within a team and drive to succeed in an international business environment.
• Ability to accurately forecast sales within the territory on a monthly basis.
• Ability to travel overnight up to 30%.

#GS

#LI-YD1  

At Element Biosciences, we are passionate about our mission to develop high performing products to study genomics with unprecedented flexibility and quality that enable researchers to better understand biology for the improvement of global health. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.

We are seeking an experienced Regional Marketing Specialist, APJ  who will play a pivotal role in supporting the channel partners, sales director and driving outbound activities that execute the business strategy and objectives in Asia Pacific Japan. The ideal candidate will interact cross functionally with members from the commercial sales and global marketing teams and will be the central point of contact for territorial market planning, implementation, new product launch and regional market development. Key skill sets include regional marketing, program localization, sales enablement, lead generation/nurture and tactical marketing. Experience within the life sciences industry is a must. This will report to the Senior Regional Marketing Manager, EMEA & APJ remotely based in the Asia Pacific Japan region.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

Essential Functions and Responsibilities:

• Spearheading the development of an annual marketing plan and budget
• Collaborating with the global marketing team to ensure alignment with the latest tools, guidelines, and standards
• Regionalizing and localizing core marketing programs across APJ countries
• Crafting, developing, and distributing marketing collaterals, gimmicks, and campaign assets to enhance customer engagement and generate leads
• Implementing lead and demand generation activities to broaden the customer database in APJ
• Lead and drive co-marketing activities with channel partners including physical, hybrid and virtual events
• Analyzing marketing plans to optimize and enhance marketing campaigns
• Sourcing, engaging, and collaborating with third-party vendors to ensure the successful execution of campaigns and assigned tasks
• Driving paid media initiatives to bolster brand awareness in the region
• Establishing and managing relationships with Key Opinion Leaders (KOLs) from a consulting standpoint
• Facilitating lead-sharing and co-selling initiatives in collaboration with Product Management, monitoring success, and intervening for improvement when necessary

Education and Experience:

• Bachelor’s degree and a minimum of 5 years’ experience in the life sciences/biotech industry
• Strong communicator with the ability to work with cross-functional teams without line management authority
• Well organized ability to help drive projects, multi-task, and prioritize projects and tasks efficiently
• Experience managing the lifecycle of a range of different product types from idea conceptualization through launch, growth and maturity, to their formal deletion
• Successful track-record of working effectively across multiple functions
• Fluency in Japanese or Korean considered a plus
• Highly collaborative and team-focused
• Experience with distributor management is a plus
• Experience with digital asset management tools is a bonus
• Excellent computing skills, with specific knowledge of Microsoft Office tool set; Salesforce.com knowledge is a plus
• Proficiency in graphic design software and tools, such as Adobe Creative Suite
• Proficient in digital marketing platforms, including HubSpot, analytics tools, and social media channels

Physical Requirements:

• Frequently moves boxes weighing up to 20 pounds

Location:

• Remote – Singapore, Malaysia, Vietnam and Taiwan 

Travel: 

• Ability to travel up to 20% internationally

Job Type:

• Full Time

Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience. 

We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Summary

QuEra Computing is seeking a qualified candidate to help develop algorithms and applications in collaboration with external customers, collaborators, and users. With an outcome-oriented mindset, you will work on projects ranging from machine learning, operations research, data science, chemistry, and more. Working individually and as part of a team, you will interact with clients, business partners, collaborators, and other users of quantum computers to implement algorithms, develop use-cases, and create business solutions that leverage near and intermediate-term neutral atom quantum computers.

QuEra Computing is the leader in neutral atom quantum computing, and is a front runner in the race towards utility-scale quantum computing. In this role, you will be at the cutting edge of quantum computing development. Your contributions and ideas will help steer QuEra and the entire field to practical quantum utility.

Qualifications

• MSc or a Ph.D. degree in applied mathematics, computer science, physics, or a related discipline, or equivalent professional experience
• Expert knowledge of at least one of the fields of quantum machine learning, quantum optimization, quantum chemistry, or quantum information science
• Strong knowledge of the fundamentals of quantum computing and algorithmic primitives
• Strong written and verbal communication skills
• Ability to collaborate effectively across multidisciplinary teams
• Proficiency in Python
• Strong written and verbal communications skills in both English and Japanese

Preferred Qualifications

• Expertise in an industry vertical such as logistics, finance, operations research, chemistry, biotech, engineering, machine learning, or other related field
• Experience developing client-focused quantum solutions
• Familiarity with scientific software coding practices and use of software platforms such as GitHub
• Familiarity with HPC or cloud environments
• Familiarity with neutral atom quantum computing

QuEra is committed to cultivating a diverse work environment and is proud to be an equal opportunity employer. We highly value diversity in our current and future employees and do not discriminate (including in our hiring and promotion practices) based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

職位：量子ソリューション科学者   

勤務地：日本（リモートワーク可／応相談） 

職務概要 

QuEra Computingでは、社外の顧客・共同研究者・ユーザーと連携しながら、量子アルゴリズムやアプリケーションの開発を推進できる量子ソリューション・サイエンティストを募集しています。 

本ポジションでは、成果志向のアプローチを重視し、機械学習、オペレーションズリサーチ、データサイエンス、化学など多様な分野のプロジェクトに取り組みます。クライアントやビジネスパートナーと協働し、アルゴリズムの実装、ユースケースの開発、そして中性原子量子コンピューターを活用したビジネス課題の解決に挑戦していただきます。 

QuEra Computingは、中性原子量子コンピューティングの分野で世界をリードする企業であり、実用規模の量子コンピューター実現に向けた最前線に立っています。このポジションでは、あなたのアイデアと研究成果がQuEraおよび業界全体を「実用的な量子コンピューティング（quantum utility）」の時代へと導くことになります。 

主な業務内容 

• クライアントや共同研究パートナーとの協働による量子アルゴリズム・アプリケーションの設計および開発 

• 各業界（金融、製造、物流、化学など）における量子コンピューティングのユースケース創出 

• データ分析、モデル開発、アルゴリズム実装を通じた実証実験およびソリューション提案 

• 海外チーム（米国ボストン本社など）との共同研究および技術的コミュニケーション 

応募資格 

• 応用数学、計算機科学、物理学、または関連分野の修士号または博士号、もしくは同等の実務経験 

• 量子機械学習、量子最適化、量子化学、または量子情報科学のいずれかの分野における専門的知識 

• 量子コンピューティングの基礎理論およびアルゴリズムに関する深い理解 

• Pythonを用いた開発スキル 

• 優れた英語および日本語でのコミュニケーション能力 

• 学際的・国際的なチームでの協働経験 

望ましいスキル・経験 

• 物流、金融、オペレーションズリサーチ、化学、バイオテクノロジー、工学、または機械学習などの分野での専門知識 

• 顧客課題にフォーカスした量子ソリューションの設計・開発経験 

• GitHub等を利用したソフトウェア開発およびバージョン管理経験 

• HPC（高性能計算）またはクラウド環境での開発経験 

• 中性原子量子コンピューティングに関する理解・経験 

求める人物像 

• 新しい技術を積極的に学び、チームとともに成長できる方 

• 研究成果を社会実装へとつなげることに情熱を持つ方 

• グローバルな環境でのコミュニケーションを楽しめる方 

ダイバーシティとインクルージョン 

QuEra社は多様性に富んだ労働環境を育むことを使命としており、機会均等な雇用者であることを誇りとしています。現在および将来の従業員の多様性に高い価値を見出し、採用と昇進のプロセスにおいて、人種、宗教、肌の色、国籍、性別、性自認、性的嗜好、年齢、配偶者の有無、兵役経験の有無、障害の有無、およびその他法律で保護された特性による差別を行いません。 

#LI-NB1