Job Detail

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change

Process CMC Expert 

Job Tasks & Responsibilities:

• Maintain (author, update and review) Common Technical Documents (CTD) and technical protocols, reports and technology transfer documents for regulatory submissions, e.g. CMC changes/ variations, post-approval change management protocols and for marketing licensure applications (MAAs/BLAs)


• Utilize technical product/process understanding to evaluate the impact of the change (Technical and/or GMP aspects and/or regulatory relevant)


• Transfer of external change requests to the Bayer change management system, preparing the change application in such a way that it is understood by all relevant functions (regulatory, quality, supply chain, etc)


• Setup and maintain CMC changes in the data base, perform CMC applicant assessments


• Assess suitability of documentation provided by Contract Manufacturer Organizations (CMO) to reflect the information adequately in the registration dossier sections impacted by the change(s)


• Ad hoc preparation of answers to questions from health authorities

Job Requirements:

• Degree in Life Science or equivalent with experience in support of CMC, start-up, tech transfer, and/or sustaining cGMP commercial drug substance and/or drug product manufacturing process operations in biopharmaceuticals and/or an equivalent combination of education and experience: - BS (6+ years of experience) - MS (4+ years of experience) - PhD (2+ years of experience)


• Experience inbiotech manufacturing especially with large scale bioreactors and/or purification and/or demonstrated experience / technical knowledge with drug product manufacturing is required (i.e. Formulation, aseptic filling, lyophilization)


• Knowledge of ICH guidelines and cGMP regulatory guidelines for EU and USA


• Experience in preparation and management of CMC documents


• Ideally, some experience in external manufacturing of biologics


• Able to effectively manage multiple projects, deadlines and priorities simultaneously


• Proficient with Microsoft applications


• Strong interpersonal skills, excellent organizer


• Fluent in English is a must. German, French and Spanish are an asset


• Flexibility to adapt to a fast moving and international environment


• Team player, task oriented and keen on working in a cross-cultural environment

Location:

Switzerland : Basel-City : Basel  

Division:

Pharmaceuticals 

Reference Code:

416867