Senior Manager Commercial Analytical Operations

Job content

Job Summary (Primary Function)

The Sr Manager is based in the European Headquarters in Morges area, reporting to the Director Global Projects Commercial Manufacturing.

The Sr Manager is responsible for the management of analytical operations associated with Incyte’s commercial products. The incumbent oversees analytical and quality control activities performed at CMOs and contract laboratories in relation to commercial Drug Substances and Drug Products. These responsibilities are performed in close collaboration with Analytical Development and Commercial QA groups.

Essential Functions Of The Job (Key Responsibilities)

• Manage the day-to-day analytical activity oversight at CMOs and external laboratories to ensure timely delivery of analytical documentation.
• Coordinate resolution of analytical deviations, OOS and OOT at Incyte CMOs and external laboratories.
• Act as an owner and /or technical expert for Change Controls and Deviations initiated in Incyte eQMS.
• Work with Analytical Development Department to solve atypical technical issues at CMOs and external laboratories as needed.
• Review CMO and external laboratory risk assessments (e.g. elemental impurities, nitrosamines, microbiological testing).
• Perform CMOs and external laboratory analytical batch raw data and COA reviews.
• Review and approve CMO and external laboratory analytical method validation/qualification/transfer protocols and reports.
• Lead method transfers post-initial launch (e.g Method transfer in Russia, JP,…).
• Review and approve CMO and external laboratory analytical methods and specifications.
• Review and approve CMO and external laboratory stability protocols and reports and manage Incyte stability tables for regulatory submissions.
• Maintain and update Incyte DS and DP analytical specifications as appropriate.
• Review and approve Drug Substance and Drug Product Incyte monographs.
• Manage analytical / stability related documentation in the eDMS.
• Review Quality Technical Agreements and / or Business Agreements with CMOs as it pertains to analytical operations.
• Write analytical parts of Incyte APQRs.
• Establish and maintain the Incyte commercial analytical SOPs.
• Attend CMO and external laboratory audits as an analytical SME.
• Interpret GMP, general regulatory requirements and Quality systems regulations in the area of Quality Control 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.
• Contribute positively to a strong culture of business integrity and ethics.
• Act within compliance and legal requirements as well as within company guidelines.
  

Qualifications (Minimal acceptable level of education, work experience, and competency)

• MS or Ph.D degree in Chemistry.
• Experience of min 10 years in Pharmaceutical or Biopharmaceutical industry with at least 5 or more years of QC experience at a manufacturing site.
• Strong knowledge of analytical method validation, pharmaceutical drug substance/drug product analytical technique and microbiological testing requirements. Direct experience laboratory equipment/testing and software preferred (e.g. UV, IR, MS, NMR, XRPD, HPLC, GC).
• Experience in dealing with Contractors.
• Thorough knowledge in cGMP and global regulatory requirements.
• Demonstrated ability to write technical documents such as PQR.
• 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.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here .

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.