奕安济世,您将在互相尊重、团结、信任和协作的氛围中,与杰出人士一起用最领先的尖端科学和卓越技术应对各项挑战,并找到属于您的目标和乐趣。


奕安济世拥有卓越的团队。我期待有更多优秀人才的加入,与我们一起共同努力,让全球更多的人能够更公平地获得创新生物疗法和药物。
—— 奕安济世共同创始人及亚洲总裁 赵奕宁


 

Head of Drug Substance Manufacturing

Just.– Hangzhou Zhejiang

The position is based in Hangzhou JUST Biotherapeutics Co., Ltd. at Hangzhou City, Zhejiang Province, China, with the first year on the job splitting time between JUST China and JUST US based in Seattle while the brand new greenfield China facility being designed and constructed. This position reports to the Vice President, Operations and Head of Hangzhou Manufacturing Facility. This position will work as part of an international team and will be a member of Operations Executive Team.

learn more

Job Grade:

Director or ED (depending on qualification and/or experiences)

Description:

  • This position will be responsible for overseeing the complex day-to-day work of biopharmaceutical drug substance manufacturing in a multi-product clinical and commercial facility to meet goals of quality, productivity and efficiency under cGMP conditions;
  • This position will be responsible for providing strategic direction for the manufacture and technical support of mammalian cell-based biotherapeutics for clinical and commercial use
  • This position will be responsible for managing a team of staff to achieve high performance levels and will be accountable for staff effectiveness;
  • This position will be responsible for establishing, implementing, and maintaining cGMP systems and processes required to ensure high quality operation and compliance;
  • This position will facilitate communication across functions and with external partners/collaborators;
  • This position will develop and manage functional area capital and expense budgets, and develop models for resource, economic, and/or process analysis;
  • This position will be responsible for driving and facilitating continuous process improvement and for developing and maintaining Key Performance Indicators (KPI).

Requirements:

  • Ph.D. in scientific or engineering discipline with 6-12 years of industry experience or BS/BA in scientific or engineering discipline and 15+ years of industry experience
  • Demonstrated leadership and management experience is required for this position.
  • Proven ability to manage staff to achieve high performance; organize and prioritize functional area tasks to achieve results, and accurately assess staff performance.
  • Direct involvement in the development and implementation of GMP production process of bio-therapeutics
  • Demonstrates a deep knowledge of all facets of disposable-based biologics manufacturing and operations in a highly regulated environment.
  • Exhibits sound judgement, within defined practices and policies, for decision making related to manufacturing compliance, technology development, or obtaining results.
  • Provides forward looking recommendations on how department/function can contribute to attain short- and long-term goals; anticipates and seeks to prevent potential road blocks to achieving objectives
  • Demonstrated ability to make sound recommendations and identify potential impacts to senior management across functions.
  • Expert knowledge of cGMP requirements and experienced in the development, implementation and maintenance of associated systems.
  • Subject matter expert for manufacturing technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns.
  • Anticipates complex technical issues and proactively develops practical and innovative solutions; proven ability to develop novel processes or approaches within a broad discipline; history of introducing or creating new technologies and concepts.
  • Exceptional performance in leadership roles that contributed to the achievement of department/project team objectives; significant contributor to multi-disciplinary and multi-functional teams; mentors and provides career and technical advice to colleagues within the function.
  • Exceptional communications skills are required; ability to clearly communicate and accurately present scientific/technical information, both formally and informally, to a diverse set of audiences, including senior management, external partners and the scientific community.

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant.We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines.The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics.Come join our team of experts to help shape a better future.

 

Please send your resume to: hr@justbiochina.com


 

Head of Purification Process Development

Just.– Hangzhou Zhejiang

The position is based in Hangzhou JUST Biotherapeutics Co., Ltd. at Hangzhou City, Zhejiang Province, China. This position reports to the Senior Vice President, Process and Product Development. This position will be a member of Product Development Executive Team.

learn more

Job Grade:

Director or ED (depending on qualification and/or experiences)

Job Responsibilities/Department Description:

We are seeking a Director/Executive Director of Downstream and Formulation Process Development. This position will lead and advance purification development sciences and is one of the key leadership roles in the P&PD organization. Specifically, the role will lead the Protein Purification Development group responsible for the development of multiple therapeutic antibody and recombinant proteins for early to late phase projects.

Functional responsibilities include design and characterization optimization of therapeutic proteins downstream purification and formulation/fill finishing process development, establishment of a next generation platform that may significantly impact the biomanufacturing.

The candidate will actively partner with the upstream team, Manufacturing, Analytics, Project Management, and US partners in a matrix, team organization to achieve a seamless and platform purification process approach. The candidate will lead internal and partnered projects including program review, assessment of IP and competitive landscape, and coordination of activities across functional and matrix organizations. The candidate will be a member of the executive leadership team of the Process and Product Development organization, and will be involved in regular program deep dive reviews and will support the establishment of the best in class purification development organization, thereby ensuring high standards.

Key Responsibilities:

  • Partner with Just US Process Development, Clinical Manufacturing and Hangzhou Manufacturing organizations to ensure seamless transition and transfer of processes. Coordinate experiments with matrix teams to ensure rapid achievement of objectives and overall process transfer goals.
  • Direct support and solve technical issues for the Manufacturing in a timely manner.
  • Develop and implement novel purification approaches to advance Just competitive advantages.
  • Direct continuous process improvements for the group and matrix organizations.
  • Manage staff, budget and equipment acquisition and potential expansion.
  • Provide performance feedback, coaching, career development and mentoring to each team member to ensure their success and fulfilment.
  • Develop and implement purification process development, process characterization, and support PPQ activities of therapeutic proteins
  • Apply advanced DoE approaches to facilitate refined process development programs
  • Drive new technology initiatives, establish intra and inter-departmental and external collaborations, and direct the necessary experiments for evaluation and implementation
  • Lead project and matrix team meetings and coordinate activities for the project team with other process development focus groups
  • Write technical project reports and lead program reviews on a regular basis in matrix organization

Qualification:

  • PhD in Chemical/Biochemical Engineering, Biotechnology, Protein Chemistry or Biochemistry
  • Minimum of 6 years of experience in Process Development/Purification Process Development with a minimum of 2 years of managerial experience
  • Track record of successful implementations of a robust purification process from development to a commercial setting
  • Track record of demonstrable management skills of multiple projects and technical teams
  • Experience with all aspects purification development unit operations, including Protein A, Ion Exchange, and Hydrophobic Interaction with different modalities
  • Experience with scale up and scale down models for multiple therapeutic proteins
  • Experience with US/EU and China IND/BLA filing
  • Demonstrated experience in technical transfer of commercial processes
  • Working knowledge of analytical sciences
  • Working knowledge of upstream and primary recovery
  • Working experience of Design of Experiments
  • Excellent oral and written communication skills; Fluent in English and Chinese

Preferred Qualifications:

  • Must work well within a fast-paced, dynamic and team-oriented environment.
  • The candidate should be self-motivated, strongly driven to succeed, inquisitive, and have excellent organizational, interpersonal, communication and problem-solving skills.

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant.We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines.The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics.Come join our team of experts to help shape a better future.

 

Please send your resume to: hr@justbiochina.com


 

Head of Cell Science and Engineering

Just.– Hangzhou Zhejiang

The position is based in Hangzhou JUST Biotherapeutics Co., Ltd. at Hangzhou City, Zhejiang Province, China. This position reports to the Senior Vice President, Process and Product Development. This position will be a member of Product Development Executive Team.

learn more

Job Grade:

Director or ED (depending on qualification and/or experiences)

Job Responsibilities/Department Description:

The Process and Product Development within Hangzhou JUST is to develop novel and biosimilar protein drugs and processes for phase I to commercial manufacturing. We also take in charge of development and implementation of products and processes developed by our US partners for China regulatory filing. This department is responsible for the development and implementation of “state of the art” and innovative technologies required to demonstrate and mature the Just production platform for therapeutics. This group will support implementation for clinical and commercial manufacturing in Hangzhou‘s “State of art” facility. This is an exciting opportunity with the potential to have a significant impact on future biologics manufacturing technology.

We are seeking a Director/Executive Director with extensive experience in mammalian cell culture process development. The successful candidate will be expected to work collaboratively with our US partner and drive the technology transfer and development of highly intensified, state-of-the-art, chemically-defined and highly productive upstream processes, and to integrate such processes with downstream development to ensure a robust, well-controlled, and well-understood biopharmaceutical manufacturing platform.

This person needs to be a highly motivated, organized, flexible and creative individual. He/she is a problem solver, willing to take calculated risks if necessary to achieve the desired goals, must be able to set team goals and define strategies to achieve them, and to provide leadership within a critical function. This person must be able to establish good working relationships with our US partners, vendors and internal colleagues (e.g. engineering, downstream, analytical) key to the establishment of a fully integrated platform, and to effectively represent these activities and the platform to senior management and across a global organization. This position is required to support technology transfer into cGMP/commercial biomanufacturing facilities. This is an exciting opportunity to participate in new technologies development and implementation into real world applications.

The head of upstream process development will develop models for resource, economic, and/or process analysis, in charge of group budget.

Basic Qualifications:

  • Ph.D. in Biochemical Engineering, Cell Biology, Biochemistry, Bioengineering, or related fields and 5 plus years of relevant industry experience.
  • Experience working independently, manage teams, multitask, and to provide leadership.
  • Experience with the application of scientific and technical knowledge in contemporary bioreactor-scale mammalian bioprocess development and process optimization.
  • Experience with mammalian bioreactor systems ≥500L working volume.
  • Experience with chemically-defined mammalian cell culture media/feed design and optimization.
  • Experience with perfusion mammalian cell culture processes
  • Team player, experience working collaboratively and productively with interdisciplinary teams/functions, downstream counterparts, and external vendors to meet objectives.
  • Experience with Design of Experiments (DOE) approach for process development and characterization desirable.
  • Experience with formal technology transfer from pilot plant to commercial production
  • Experience with China and/or US/EMEA IND/BLA filing

Preferred Qualifications:

  • It is desirable to have a solid understanding of current Good Manufacturing Practices (cGMPs) requirements and considerations.
  • Must work well within a fast-paced, dynamic and team-oriented environment.
  • The candidate should be self-motivated, strongly driven to succeed, inquisitive, and have excellent organizational, interpersonal, communication and problem-solving skills
  • Capable of directing cell line development. 

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant.We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines.The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics.Come join our team of experts to help shape a better future.

 

Please send your resume to: hr@justbiochina.com