Project Manager, Chemistry, Manufacturing

il y a 4 jours

Lyon e, France AUROBAC THERAPEUTICS Temps plein

**PRESENTATION OF THE COMPANY**

AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux.

Dedicated to addressing high unmet medical needs associated with infections in acute hospital settings, amidst the growing antimicrobial resistance (AMR) epidemic, AUROBAC is advancing a robust pipeline.

With strong growth ahead, within an international environment, the company is now looking for a Project Manager CMC.

**DESCRIPTION**

As a Project Manager CMC at AUROBAC, you will manage the development of products in our pipeline and contribute to the CMC department transversal activities.

You will report to Head of CMC and work closely with Project Management, Clinical Operations, Quality Operations & Regulatory Affairs teams.

**MISSIONS**

**- Manage process development, analytical and stability activities conducted by external subcontractors**
- Monitor development plan execution, timelines & deliverables, identify and escalate risks
- Review technical documentation, analyze and interpret results
- Lead weekly project meetings with subcontractors, produce/review agendas & minutes

**- Interact & collaborate with project team members & external experts**
- Work closely with Clinical Operations team to coordinate clinical trial supplies
- Work closely with Quality Operations team to manage quality events (deviations, OOS/OOT, change controls) and ensure Good Manufacturing Practices (GMP) compliance
- As needed request & prepare meetings with external experts, draft and distribute agendas & minutes

**- Ensure communication with project and executive teams**
- Share progress of development activities during monthly project meetings
- Complete trackers for project activities follow-up
- Produce material to support decision making

**- Contribute to CMC department transversal activities**
- Supply & consolidate development trackers (clinical batch history, manufacturing parameters & results, stability timepoints & results)
- Manage stock, supply & dispatch activities

**- Carry out literature research & technological/regulatory intelligence in accordance with project (excipients, formulation techniques, guidelines )**

**SKILLS**
- Strong knowledge of formulation, process and analytical development
- Good knowledge of Good Manufacturing Practices
- Experience in subcontractor management is required
- Experience in parenteral forms pharmaceutical development is a plus
- Fluency in English is a must-have, French language skills would be a major plus
- Used to working in an international environment

**TRAINING AND EXPERIENCE**
- PharmD, Master of science in biotechnology or chemistry or chemical engineering
- At least 2 years experience as scientist in the pharmaceutical industry

**Job Types**: Full-time, Permanent
Status: Cadre

Pay: 40,000.00€ - 55,000.00€ per year

**Education**:

- Master's (required)

**Experience**:

- Scientist: 2 years (required)

**Language**:

- English (required)

Work Location: In person

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