Manager/Sr Manager Commercial Process Operations

Job content

Summary

This role is based in the European Headquarters in Morges area, reporting to the Director Global Projects Commercial Manufacturing.

This position will be responsible for the management of small molecules process operations associated with Incyte’s commercial products. The role as a single contributor, will oversee process activities performed at CMOs in relation to commercial Drug Products. These responsibilities will be performed in close collaboration with Process Pharmaceutical Development and Commercial QA groups.

Duties and Responsibilities

• Manage 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 at Incyte CMOs.
• Act as owner and /or technical process expert for Change Controls and Deviations initiated in Incyte eQMS.
• Work with Process Pharmaceutical Development Department to solve technical issues at CMOs.
• Lead process transfer and process validation post-initial launch for small molecules programs ( Tablets / Cream ).
• Review/Approve CMO Process risk assessments/ Process documents ( Validation plan , protocol , master batch record ) linked to process transfer.
• Perform CMOs documentation batch technical review.
• Maintain and update Incyte DP process specifications as appropriate.
• Review and approve Drug Product Incyte monographs.
• Review Quality Technical Agreements and / or Business Agreements with CMOs as it pertains to process operations.
• Review manufacturing part of submitted regulatory dossiers for small molecules programs ( Tablets / Cream ).
• Write process parts of Incyte APQRs.
• Establish and maintain the Incyte commercial process SOPs.
• Attend CMOs audits as process SME.
• Interpret GMP, regulatory requirements and pharmaceuticals regulations in the area of Process and ensure implementation as applicable.
• Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
• Stay current with the applicable regulations and guidelines.
  

Company Culture

• Contribute positively to a strong culture of business integrity and ethics.
• Act within compliance and legal requirements as well as within company guidelines.
  

Requirements

• MS degree in Pharmaceutical Process.
• Experience of min 15 years in Pharmaceutical industry with at least 5 or more years of experience at a manufacturing site.
• Strong knowledge of process validation regulations for drug product (Tablets and cream), and various process technique.
• Experience in dealing with contractors.
• Thorough knowledge in cGMP and global regulatory requirements.
• Demonstrated ability to write technical documents.
• Strong Interpersonal skills.
• Strong verbal and written communication skills with well-structured communication.
• English fluency written and spoken (the company language), German and French are an asset.
• Travel up to 20 %.
• Results focused with good interpersonal skills, diplomacy, negotiation skills and common sense.
  

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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