Associate Director Science & Technology (m/f/d)

Job Description Summary

We are seeking a highly skilled and motivated Analytical Expert at the Associate Director level to develop and implement analytical strategies to support late-phase product development and regulatory submissions for accelerated Biologics portfolio projects.

As senior Analytical Expert (AE), you will lead analytical project activities and apply excellent scientific expertise to enable Drug Substance (DS) and Drug Product (DP) product and process development within a multidisciplinary project team developing new biological drugs.

 

Job Description

We are looking for an experienced scientist with deep analytical expertise, as well as expertise in Drug Substance (DS) and Drug Product (DP) process development, and solid project management skills to efficiently collaborate with our internal and external partners to support our high-priority project portfolio assets. The successful candidate will provide critical input regarding technical and regulatory risks to facilitate submissions, demonstrate a strong product mindset, and possess an outstanding scientific and technical background. 

Key Responsibilities:

• Lead and manage all analytical activities related to DS and DP product and process development. 

• Design, supervise, and coordinate analytical development activities for assigned projects, managing multiple tasks simultaneously to meet customer needs. 

• Oversee analytical method development and provide scientific guidance for the matrix team within assigned projects (novel protein-based biopharmaceuticals). 

• Lead and oversee a set of analytical activities performed in-house or outsourced, including setup and control of time schedules within the project. 

• Evaluate and interpret results of analyses, draw relevant conclusions, review and approve analysis, critically evaluate results, and discuss conclusions with other scientists. 

• Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Manufacturing, to drive project success. 

• Ensure compliance with GMP, GLP, and other relevant regulatory guidelines and standards. 

• Ensure strong stakeholder management skills to assure frictionless collaboration with our internal customers as well as external partners, including Clinical Research Organisations (CROs). 

Minimum Requirements:

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, biotechnology, biochemistry, chemistry, chemical engineering, or a related field with a minimum of 5 years of relevant experience; or a Master's degree with a minimum of 7 years of relevant experience. 

• Proven track record of leading analytical activities in the pharmaceutical or biotechnology industry. 

• Strong understanding of regulatory requirements and experience in preparing regulatory submissions. 

• Demonstrated ability to work effectively in cross-functional teams and manage multiple projects simultaneously. 

• Advanced knowledge in a wide range of analytical techniques, including chromatography, spectroscopy, and mass spectrometry. 

• Expertise in Biologics DS and DP process development. 

• Experience with method development, validation, and transfer. 

• Familiarity with quality by design (QbD) principles and risk-based approaches to analytical development. 

• Solid project management skills. 

You’ll receive: 

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €82.600/year (on a full-time basis).

We also offer a potential market oriented excess payment in line with your experience and qualifications.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

Adjustments for Applicants with Disabilities:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during th