Contract Senior Manager for Analytical Development and Quality Control

Michael Parker at Umbilical Life is currently recruiting a Senior Manager for Analytical Development and Quality Control, on an initial 12 month contract. The role is based in Basel and likely to extend past the initial 12 months.

In this role, you will report directly to the head of Analytical Development and QC. Aside from this, you will be responsible for the company’s CMC projects in terms of the development of analytical methodology and characterization of sterile drug products.

It is important that you can support analytical activities in-house, as well as in contract development and manufacturing organisations (CDMOs).

Role Responsibilities:

• Contribute on the development and implementation of analytical strategies for development stage projects to achieve optimal results.
• Identify analytical science capabilities and technology tools needed to enable sterile manufacturing process development, QC testing, and new drug candidate formulation development for parenteral formulations.
• Apply scientifically-driven thinking to the development of scientifically sound, well understood, and phase appropriate analytical methods for parenteral drug products.
• Manage CRO/CMO for analytical activities.
• Provide technical input in the investigation of OOS and OOT investigations
• Review technical documents for regulatory submissions.
• Write specifications for parenteral formulations.
• Provide support and contribute to other analytical activities as necessary.
• Contribute on the robust analytical CMC development strategies, plans, timelines and budgets and track status, progression, critical success factors and risk factors in the ongoing and planned CMC development projects. Method transfer to contract manufacturing organizations.

Qualifications:

• Related pharmaceutical experience combined with B.Sc. degree 10+, M.Sc. 7+ or PhD 5+ years of relevant working experience in analytical development and/or quality control for parenteral products including sound understanding of microbial testing/monitoring.
• Skilled in the application of cGLP/cGMP.
• Extensive analytical development background and hands-on experience with working knowledge of chemistry, analytical or pharmaceutical science.
• Experience with contract labs or managing outsourcing in a drug development industry, stability studies for pharmaceutical products, HPLC method development and validation, project management and audits.
• Experience in late phase development activities, e.g. analysis of drug product supplies for pivotal clinical trials, registration stability studies and process validation Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
• Prior experience in the development of analytical methods for complex injectable products and medical devices.
• Comprehensive knowledge of parenteral manufacturing and aseptic technologies.
• Expertise in the development and validation of analytical methods used for the characterization and control of parenteral products.
• Proven track record in parenteral drug product development, and integration of container-closure and device delivery systems.
• Experience with Investigational New Drug (IND), New Drug Applications (NDA) and responding to CMC questions from FDA/international regulatory authorities.
• Excellent interpersonal/ organizational skills and the ability to multi-task. Strong oral/ written communication skills, proficiency in English. German/French is a plus.
• Ability to travel ca. 10% domestic and internationally.
• Computer literacy (e.g. Waters Empower, ELN).

For more information on this role or any of the others I am recruiting please get in touch directly to Michael Parker at Umbilical Life