摘要
Job Type: Hybrid #LI-Hybrid
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.
About the Role
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:
- Design, supervise, and coordinate analytical development activities for assigned projects, managing multiple tasks simultaneously to meet customer needs, as well as oversee analytical method development and provide scientific guidance for the matrix team within assigned projects (novel protein-based biopharmaceuticals).
- Provide physicochemical analytical support and drive testing strategy (e.g., purity, content, physical properties) for all sample matrices (i.e., DS, DP, process intermediates). Evaluate and interpret results of analyses, draw relevant conclusions, review and approve analysis, critically evaluate results, and discuss conclusions with other scientists.
- Author and review scientific reports intended for internal and external partners and support the preparation of registration documents. Contribute to answers to HA questions. Act as an analytical expert in health authority inspections or internal audits.
- Identify and mitigate technical and regulatory risks associated with analytical methods and data and actively drive mitigation strategies
- Actively drive knowledge sharing, present scientific results internally, and publish to publications, presentations, and patents.
- Contribute to the development of long-term strategies on science and technologies within the analytical domain, actively drive strategies in Process Analytical Sciences by leading cross-functional teams or scientific programs
- Act as a subject matter expert in analytical sciences, providing guidance and mentorship to senior team members.
- 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.
- Good overview of current trends and upcoming techniques for current and future applications.
- Strong understanding of regulatory requirements and experience in preparing regulatory submissions.
- Excellent problem-solving skills and the ability to address complex scientific and technical challenges.
- Demonstrated ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
- Outstanding communication and interpersonal skills, strong leadership and mentoring abilities.
- Advanced knowledge in a wide range of analytical techniques, including chromatography, spectroscopy, and mass spectrometry, expertise in Biologics DS and DP process development
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 the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Adjustments for Applicants with Disabilities
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
