Associate Scientist/Principal Scientist, Process Engineering, Pharmaceutical Science

単位操作の研究のためのスケールダウンモデルの開発、プロセスの安全性評価、および外部製造受託機関への技術移転を担当

仕事内容

How you will contribute:
・The successful candidate will be responsible for all aspects of reaction ＆ particle engineering including the development of scale down models for the study of unit operations as well as technical transfer to external contract manufacturing organizations. He/ she will have deep experience in using process analytical technologies (PAT) in combination with mathematical models (both statistical ＆ first principle) to enhance process understanding to effectively develop/ optimize/ scale-up and troubleshoot processes. The Senior Engineer will have experience building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes.

He/ she will be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences and utilize his/ her technical expertise to contribute across multiple projects and drive technical/scientific strategy. The Senior Engineer will be responsible for benchmarking current trends in research, development and manufacturing technologies, developing initiating and/or participating at a high level in projects that involve extraordinary, well-considered risks along with scientific/technical challenges, as well as directing and managing outsourcing across a product platform, as appropriate.

Accountabilities:
Develops project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department
Contributes significantly and independently to project work which may include multiple projects within functional area.
Plans and implements resolutions to technical problems/issues
Independently designs and executes experiments, and reports results
Recommends, justifies and implements technologies and innovations.
Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills.
Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
Reviews, interprets and communicates data cross functionally within pharmaceutical sciences and project teams
Conducts analysis of technical and conceptual risk and trends
Identifies process trends and defines/champions process strategy or use of novel technologies
Recognized as a technical expert and resource within function
Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences
Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff.
Defines appropriately complex/novel approaches and methodologies to solving outstanding technical challenges
Coordinates and leads technology transfer to internal or external manufacturing sites
Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.
Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.
Represents and is an active member on pre-competitive collaborations with academic and industrial partners.

応募条件

【必須事項】

Education and Experience:
・A Ph.D. degree with 3+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years of pharmaceutical industry experience. Degrees in chemical engineering required.
・Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred
・Experience in building reaction kinetic models as well as process models preferred.
・Experience in building laboratory and pilot plant equipment a plus
・Experience in crystallization process development and scale-up with an emphasis on form, purity, and particle size control a plus
・Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control a plus
・Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required
・Experience in building chemometric models preferred
・Experience in developing continuous processes a plus
・Sound knowledge of current Good Manufacturing Practices (cGMP) preferred
・Experience working in a pilot plant a plus
・Previous experience with the use of contract facilities and managing technical transfers a plus
・Experience in working in a multi-disciplinary team environment
・Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts

Knowledge and Skills:
・Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions
Teamwork - Ability to work well on global cross-functional teams.
・Communication Skills -Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents
・Organization - Exercises good time management and prioritization skills to balance multiple project and departmental objectives
Technical - Subject matter expertise in a specific scientific area or areas.
・Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
・Resource Management -Project management skills; ability to manage one’s time within individual, departmental
・External Involvement - Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects
・Leadership Skills - Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

3ヶ月

勤務地

神奈川

転勤の有無

転勤なし

受動喫煙防止措置

敷地内禁煙（喫煙場所なし）

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）

勤務開始日

応相談

休日休暇

年間休日数：123
土日祝
年間有給休暇：入社半年経過時点12日　12日 ～ 20日
法定休暇：年次有給休暇、産前産後休暇、介護休暇
特別休暇：年末年始休暇
その他休暇：特別有給休暇（慶弔、災害等）短期・長期傷病休暇、リフレッシュ休暇、ファミリーサポート休暇、子の看護休暇

年収・給与

年収　　～950万円　

諸手当

通勤交通費、借家補助費、時間外手当など

昇給

原則年1回

賞与

年2回

採用人数

1名　

待遇・福利厚生

通勤手当：有
寮・社宅：有
住宅手当：有
住宅資金融資、財形貯蓄、従業員持株会、契約保養所など
ダイバーシティ＆インクルージョン

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
厚生年金基金：有
退職金制度：有

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接