Chef de projet Expert technique - Manufacturing Operations

Your mission

For our client, active in the biotech industry, we are currently looking for a Technical Expert, specialized in Solid Forms Manufacturing.

The role will support the manufacturing process activities performed at CMOs in relation to commercial Drug Products. These responsibilities will be performed in direct link with the Senior Manager of Commercial Process Operations and in collaboration with Pharmaceutical Process Development and Commercial QA groups.

Duties and Responsibilities

- Support the day-to-day process activity oversight at CMOs to ensure timely delivery of process documentation for commercial Drug products.
- Coordinate resolution of process deviations, and support troubleshooting activities at CMOs in collaboration with internal QA & Supply and Pharmaceutical development departments
- Act as owner and / or technical process expert for Change Controls & Deviations initiated in the eQMS.
- Review and Approve Process documents: Risk assessment, Validation Master Plan and report, Master Batch Record, Drug Product monographs and APQRs.
- Lead process validation post-initial launch for small molecules programs (Oral Solid Dosage Forms) for process transfer and/or process optimization.
- Maintain and update the Drug Product process knowledge.
- Attend CMOs audits as process SME.
- Performs all responsibilities in accordance with company policies, procedures, applicable regulations, GMP and safety requirements.
- Contribute positively to a strong culture of business integrity and ethics.
- Act within compliance and legal requirements as well as within company guidelines.

Your profile

Requirements

- Bachelor's or Master (preferable) degree in Pharmaceutical Process.
- Experience of min 6 years in pharmaceutical industry with at least 3 years of experience at a manufacturing site.
- Strong knowledge of process validation regulations and CGMP for small molecules Drug Product.
- Various process expertise for Oral Solid Dosage Forms (Tablet) and Semi-Solid Dosage Forms (Cream) is an asset.
- Experience in dealing with contractors.
- Demonstrated ability to write technical documents with use of statistic.
- Good verbal and written communication skills with well-structured communication.
- English fluency written and spoken (the company language) and French is an asset.
- Travel up to 10 %.
- Results focused with good interpersonal skills, positive and proactive attitude and common sense.

Interested?

Please apply online directly !