CoE Drug Substance Global MSAT (Biologics)

Job description

CoE Drug Substance Global MSAT (Biologics)

Your role: Provide technical leadership to the existing Manufacturing Science and Technology (MSAT) network for Drug Substance (DS). Be responsible to further develop MSAT DS organization in the manufacturing network and represent the MSAT DS organization at all levels in the future. Direct projects, develop and implement initiatives to continuously improve DS manufacturing capabilities and provide effective cross-functional collaborations and communications. Provide scientific and technical expertise to all functions involved in DS manufacturing, including CMC teams for commercialized products. Provide technical leadership for the drug substance manufacturing operations, TT activities and life cycle management projects. Lead or participate in various cross-functional and/or cross site technical projects and teams related to DS manufacturing. Develop strategies and be accountable for ensuring scale-down and characterization of DS existing manufacturing processes to ensure their robust and capability/consistency. Develop and lead innovation, best practices and solutions for the drug substance manufacturing network in collaboration with our production, process development and quality functions. Lead or support complex trouble shooting, product impact assessments and process/product improvement activities in the DS manufacturing network. Foster collaboration across the DS manufacturing network to develop harmonized business processes and tools related to DS manufacturing support, TT and manufacturing innovation. Represent the company in DS related industry consortiums and coordinate associated activities

 

Who you are 

·  Degree in Life Science/Engineering required, advanced degree (Ph.D) preferred having 10 years of experience in the pharma industry, inc. 5+ years of expertise in the drug substance manufacturing (preferred) or development
·  Strong technical expertise in drug substance manufacturing of biologics for the relevant unit operations including: cell banking; upstream (fed-batch perfusion processes)/downstream processing
·  Profound knowledge of relevant regulatory guidelines, cGMP and validation practices
·  Strong analytical and problem-solving skills to support and improve our production capabilities
·  Expertise on PAT automated feedback control for upstream processes  would be a plus
·  Excellent skills in writing, oral, interpersonal communication and presentation (English); German, French or Italian would be considered as a plus

Job Requisition ID: 194596

Location: Aubonne

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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