Engineer Pharmaceutical Development

Il y a 5 mois

Pessac, France Treefrog Temps plein

**À propos de nous**:
**COMPAGNY**

Treefrog Therapeutics is an innovative biotech aiming to bring cell therapies to millions of patients, thanks to C-StemTM technology, which was developed to cultivate and differentiate stem cells on a large scale, a world 1st. Since its incorporation in 2018, Treefrog Therapeutics has raised more than € 74 million and is experiencing strong acceleration thanks to its over 120 froggies team.

**Mission**:
**JOB DESCRIPTION**

One of our main projects in TreeFrog is focus on Parkinson disease. Today, the Parkinson program is pre-clinical stage, and we aim to get to the clinic as next step. To achieve this challenge and to be able to deliver our cell therapy to patients for clinical studies, we build a new team called the delivery team.

Integrated into the delivery team, and in close collaboration with the scientist and the technician working on the pharmaceutical development project, you will participate in the implementation of a pharmaceutical reconstitution protocol in cellular therapy for our parkinson program. In charge of its implementation in pre-clinical and clinical centers, you maintain close relationships with hospital pharmacies and/ or cell therapy center. You will be working closely as well with our non-clinical, analytics, process development and physics colleagues.

**RESPONSABILITIES**

Within the delivery team, the pharmaceutical development engineer will have a wide range of responsibilities, including the following:
**1. Development and validation of a pharmaceutical cell therapy reconstitution protocol**
- Define constraints related to reconstitution in a hospital setting
- Experimental design, short and long-term project planning, experimental execution, interpretation of results, and reporting.
- Protocol validation GPL condition
- Process optimization in GMP

**2. Validation of tests in GMP condition (in use)**

**3. Product preparation for non-clinic phases and method transfer to external partner**
- Work closely with the non-clinical team to define product needs.
- Adapt protocols to animal models
- Training and transfer of methods within CROs.

**4. Protocol implementation in clinical centers**
- Participate and develop interaction with clinic centres
- Present and validate protocols within the hospital setting
- Transfer and training of hospital practicians

**5. Documentation Production**
- Ensure that all development activities are carried out in compliance with GLP, with appropriate documentation for traceability. Support regulatory filing activities
- Prepare, coordinate and present consolidated project material at internal and external meetings.
- Responsible for review of standard operating procedures and protocol.

**6. Reporting & communication**
- Prepares & communicates project status at defined intervals and meanings
- Develop and present status reports across the organization

**Profil**:
**REQUIRED SKILLS**:
With a PhD, PharmD or MS with scientific orientation (Pharmaceutical Sciences, Bio-Engineering, Science or Chemical Engineering, Industrial Engineering, Chemistry), or equivalent experience acquired through professional backround, you have appetite for experimental activities.

You have at least 2 years’ experience with technical issues and requirements for development of drug product formulation and/or processes of biologics, i.e. development and manufacturing of semi-solid, liquid and lyophilized formulations, primary packaging, and aseptic product manufacture. Ideally you have a good knowledge of the pharmaceutical industry or GLP/GMP conditions, you have accumulated experience in cell therapy and you’re familiar with hospital environment (previous experience in cell therapy units or EFS would be appreciated).

You work accurately, you are technically minded and able to work independently after training in the matter entrusted to you. You also demonstrated ability to work effectively with cross-functional groups and external partners. You speak and write English fluently.

**SOFT SKILLS**:

- Autonomous, well-organized, and meticulous
- Strong written, verbal, and interpersonal communications skills including ability to communicate scientific information clearly and effectively.
- Strong deontology & ethics
- Ability to embrace new technologies
- Strong creative, analytical, trouble-shooting skills. Solving problems in a structured and logical manner, generating and presenting options for the mitigation of issues/ risks.

At Treefrog, we are above all looking for personalities who match our values (#Do, #Dust, #Be bold, #Commit, #Enjoy). Problem-solving, scientific curiosity, the ability to get out of one's comfort zone, and the capacity to learn quickly in a highly dynamic research environment are among the qualities we're looking for.

**WORK ENVIRONMENT & CONDITIONS**

Location : PESSAC, France

Permanent contract (CDI)

Mutuelle, Food tickets

Salary : Based on experience

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