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Senior CMC Analytical Life Cycle Manager

Employer
Hobson Prior
Location
Switzerland, Nyon
Salary
Negotiable
Start date
8 Feb 2021
Closing date
5 Mar 2021

View more

Discipline
R & D
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

Hobson Prior are working with a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. Our client is looking for a Senior CMC Analytical Life Cycle Manager to join them on a permanent basis in Nyon, Switzerland.

Job Responsibilities:

  • Co-operate with CMC Development teams, Regulatory Affairs and Quality functions to co-ordinate and deliver analytical packages of the required standard for adherence to Global Health Authorities (in particular US and EU) requirements.
  • Work with project managers to write and review analytical relevant sections of Health Authority submissions including BLA and MAA and post-approval variations.
  • Manage direct/indirect interaction with internal Analytical Teams in support of Phase III development, Biosimilar licence application and post-marketing support ensuring scientific rigor and data integrity.
  • To work with Quality function to review and implement QTAs. Initiate and process CCPs and deviations with analytical SMEs.
  • Develop risk management strategies for product lifecycle maintenance.
  • Interface with external CROs, CMOs and licensing partners to set expectations, define work packages, measure progress and delivery including continuous method performance monitoring.
  • Development of long-term plans for analytical support of licensed Biosimilar products.
  • Represent the organisation's SwissBioSim at regulatory authority meetings and at internal review committees.
  • Provide guidance across biosimilar projects on scientific and quality strategy applicable to analytics.
  • Ensure rigorous and timely decision making that maintains rapid project progression while continuously weighing the many variables and uncertainties associated with the biosimilar business.
  • Understand the organisation's corporate quality standards and ensure they are adhered to in the area of Biosimilars.

Key Skills:

  • Strong analytical and organizational skills.
  • Leadership competencies (proactive problem solving, influencing and decision making).
  • Ability to work accurately with attention to detail, motivated and focused on delivery to product objectives.
  • Robust communication skills, both oral and written.
  • Strong interpersonal, networking and relationship skills required, including teamwork and listening skills.

Requirements:

  • Advanced scientific degree: MSc or equivalent with degree in biochemistry, and post grad training in respective fields.
  • At least 10 years' experience in R&D in biopharma/biotech industry.
  • Demonstrated successful track record in analytical sciences of biologics, preferably biosimilars+
  • Sound knowledge in GLP/GMP, ability to interpret guidelines and to implement compliant analytical packages in highly regulated markets
  • Proven experience in regulatory consultations for biosimilar products (preferably) and/or New Biological Entities in the EU/US
  • Significant exposure to biotech manufacturing operations and related analytics from Phase iii development to licensed Biopharmaceuticals including product life cycle management and product maintenance
  • Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development and product supply chain
  • Fluency in English essential, both oral and written; additional languages (German or French) are an asset.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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