Job description

As a trainee with an advanced chemistry background, you will master the analytical equipment and methods available in the lab, namely HPLC-UV, GPC-UV, FTIR and Invitro release test (IVRT).

Key responsibilities

• Provide primary support for R&D Analytical functions for pipeline analgesic formulations including designing and performing experiments, sample handling and data management.
• Support maintenance of internal research lab equipment and supplies.
• Support product development activities such as analytical method development and product characterization.
• Manage work with Allay R&D (San Jose, CA) and outside contract analytical laboratories as needed.

Requirements

• MS or PhD in chemistry, life sciences, chemical engineering.
• Extensive hands-on analytical chemistry experience.

Key responsibilities

• Contribute to cell therapy related process development and process characterisation.
• Design and execute experiments to evaluate, develop and optimize downstream cell therapy manufacturing processes, and to communicate/present results both internally and externally.
• Prepare technical and scientific documents including study protocols and reports, validation documents, SOPs, and test methods.
• Support technology transfer and contribute to the successful execution of pilot scale-up tests.
• Responsible for the operation and maintenance of technical platforms including cell purification and preparation.
• Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations.
• Support regulatory filing activities including authoring IND/BLA application documents, as well as to facilitate on-site verification.

Requirements

• MS or PhD in Chemistry, Pharmacy, Biochemistry, Bioengineering or other life science related fields; prior research experience in oncology or immunology will be advantageous.

About DotBio
DotBio is a highly innovative biopharmaceutical company with a mission to predict the most effective multi-functional antibody therapies, cancer therapies and derisk the clinical development process. The company generates hundreds of multi-functional antibodies with good developability and screen them in parallel in high-throughput phenotypic assays (HTPAs) against diverse cancers. This combinatorial targeting approach allows to interrogate many immuno-oncology target combinations in parallel, generating a stack of data that can be analysed to identify the most potent and derisked antibodies to move into the clinic.

Job Description:
DotBio is currently looking for a self-driven, dynamic and independent Preclinical Project Manager to join our team. The job will entail overviewing multiple preclinical projects, and interacting with scientists from the antibody discovery and validation teams, as well as CROs and CDMOs to ensure timely execution and reaching the required milestones.

Responsibilities:

• Coordinate R&D team and relevant stakeholders to meet project timelines and deliverables.
• Establish and maintain processes for managing scope, schedule, and budget during the project lifecycle.
• Analyse project status and, when necessary, revise the scope, schedule, or budget to ensure that project requirements can be met.
• Assign and monitor resources to ensure project efficiency and maximise deliverables.
• Establish and maintain relationships with R&D team and relevant stakeholders, providing day-to-day contact on project status and changes.
• Report project outcomes and/or risks to management.

The ideal candidate should have the following attributes:

• Minimum PhD with 1-5 years of relevant working experience in antibody drug development or immuno-oncology.
• Proven working experience with project management in drug development, including antibody drug development.
• Good technical background, with understanding or hands-on experience in antibody drug development.
• Excellent communication and collaborative skills are a must.
• Strong organisation, synthesis and reporting, including attention to detail and multi-tasking skills are required.
• Previous research experience in the immuno-oncology field is a plus.
• Previous experience with project management software is a plus.
• PMP certification is a plus. 

Job description

The fellow will be involved in executing laboratory operations directed towards the application of analytical methods for in-process testing, release, and characterisation of biological products, e.g., performing laboratory testing and generating laboratory data pertaining to the potency of investigative vaccines.

They will conduct routine analytical procedures for in-process control samples and for product release of biologics and biopharmaceuticals such as Mab, recombinant proteins, or vaccines. The fellow will also work closely with process development team, external consultants and contractors for the establishment and technology transfer of analytical methods, and assist in authoring high-quality technical memorandum, protocols, reports, summaries, and quantitative analysis, for the distribution and/or presentation to project teams, and for regulatory agency submissions.

Other key job responsibilities include participating in new product technology transfer, and analytical qualification and validation activities to advance Hilleman’s portfolio pipeline.

Requirements

• Masters or PhD in Biochemical Engineering, Biotechnology, Biochemistry or related Pharmacology disciplines

• Fresh graduates may apply

Job description

The fellow will be involved in the formulation and product development of Hilleman Laboratories pipeline products (including vaccines, mAbs, recombinant proteins).

Responsibilities include development of robust formulation for drug substance and drug product from discovery till phase 2 clinical development; as well as development and supporting technology transfer of scalable and robust drug product manufacturing process to process validation with manufacturing partners. The individual will drive the execution of formulation and drug product development strategies, author technical protocols, design and implement experimentation, generate technical reports, and author related CMC sections to support regulatory submissions. 

The fellow will collaborate closely with Analytical Development, as well as Process Development, Quality Control, Quality Assurance as required. This role may also require interfacing with external contract organisations.

Requirements

• Masters or PhD in Pharmacy, Chemistry, Biology or related Pharmaceutical Sciences
• 2-6 years relevant industry experience.

Job description

The fellow will get involved as a subject matter expert in process and product technology transfers from CMC to GMP clinical manufacturing of different modalities and platform to meet tech transfer objectives and timeline.

You will provide facility and equipment fit assessment expertise in biologics and vaccine plant start up and operation by providing technical input and facilitate decision makings.

In addition, you will also collaborate closely with key stakeholders within CMC/ GMP clinical manufacturing such as Operations (DS, DP), QA, Engineering, Validation, etc. in meeting operational targets and production schedules.

Requirements

• Phd in an engineering/scientific discipline (Bio/chemical engineering/life science/biology/chemistry), with industry experience as an added advantage
• Biological or Vaccine technology transfer experience would be an advantage
• Awareness of cGMP practices as applicable to upstream/downstream virus manufacturing processes, process development is desirable
• Knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
• Well-organized and detail-oriented, with ability to effectively prioritize tasks with agility, eager to learn, interact and collaborate effectively with various stakeholders in a team environment and consistently demonstrate reliability and responsibility

Job Description 

• Coordination of efforts assigned to all internal and external members of the CMC and clinical project teams, to support milestone achievement and overall project delivery 
• Coordination of logistics of any required material, technology, and information transfer between internal resources and external partners, including CROs and CDMOs 
• Contribute to the planning of the clinical development strategy:
  • Understand the scientific context and identify key data from public sources, including scientific literature, conference reports, data portals etc., relevant to clinical development of TCR candidates 
  • Identify, network and consult with internal stakeholders, clinical KOL and advisors to collect information that will support data-driven strategic decisions on clinical development of TCR-T candidates 
• Summarise and present relevant data around the TCR target to the direct supervisor and management 
• Analyse and understand the competitive landscape 

Requirements

• PhD degree in biological sciences or a related field 
• Excellent scientific understanding of biology; specialisation in immunology and T-cell biology preferred 
• Ability to summarise a large amount of information 
• Ability to write succinct reports/slide decks and present clearly and concisely 
• Skilled at multi-tasking and working in a fast-paced environment with the management of competing priorities to meet deadlines 
• Excellent communication skills