Associate Director Technical Project Management - Novartis Contract Manufacturing

Novartis; Osterreich; Hybrid; PEN 331,000 - 615,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks paid parental leave

Job summary

Novartis is seeking a Technical Project Lead to oversee end-to-end CMC execution for biologics Drug Substance projects within the Contract Manufacturing network. You will be the main customer-facing interface and leader of multi-disciplinary teams spanning DS development, manufacturing, MS&T, Quality, Regulatory, and more.

Role requires 5+ years in biopharma, strong DS process knowledge (mammalian/microbial), and proven ability to translate contracts into actionable plans while managing

Qualifications

• Bachelor’s, Master’s, or PhD in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related scientific discipline.
• Minimum 5+ years of biopharmaceutical experience, with substantial exposure to biologics Drug Substance development, manufacturing, MS&T, technology transfer, or CMC project leadership.
• Strong technical understanding of mammalian and/or microbial DS processes, including upstream and downstream operations, process validation, analytical control strategies, and manufacturing scale-up.
• Demonstrated experience in managing external customers and delivering against contractual scope.
• Sound knowledge of GMP manufacturing operations, quality systems, change control, deviation and CAPA management, and global regulatory expectations.
• Proven ability to lead complex, cross-functional DS technology transfers and manufacturing programs within a global matrix organization.
• Strong commercial awareness, including the ability to connect technical execution with contract scope, customer commitments, capacity, cost, and supply performance.
• Demonstrated ability to resolve complex technical and operational issues, drive timely decisions, manage risk, and maintain a strong customer- and delivery-focused mindset.

Responsibilities

• Act as the technical project lead and single point of contact for biologics Drug Substance (DS) programs manufactured within the Novartis Contract Manufacturing network.
• Own customer DS projects end to end, from Business Development and contract handover through technology transfer, site onboarding, GMP execution and validation.
• Lead cross-functional teams across DS development, manufacturing, MS&T, Quality, Regulatory, Supply Chain, Engineering, and Commercial functions within the Novartis matrix organization.
• Translate contractual obligations and customer requirements into integrated project plans, governance, milestones, deliverables, and resource priorities.
• Ensure robust transfer and manufacturing readiness for mammalian and/or microbial DS processes.
• Drive delivery against customer commitments for quality, timelines, capacity, cost, and supply reliability, proactively managing technical, operational, regulatory, and commercial risks.
• Lead customer governance, including Joint Project Team and Joint Steering Committee meetings, and maintain trusted, transparent relationships throughout the contract lifecycle.
• Support change controls, deviations, investigations, CAPAs, regulatory submissions and inspections, and lifecycle improvements.

Skills

Contract Management

Project Management

Education

Bachelor’s/Master’s/PhD in Biotechnology or related

Job description

Salary Range:

€85,900.00 - €159,500.00

Job Description Summary

Technical Project Lead responsible for the end-to-end CMC execution of customer projects, acting as the primary interface between the customer and site functions. Leads cross-functional teams across DS, DP and Analytics, drives project strategy and execution, manages risks and stakeholder alignment, and ensures effective communication with customers and management. Requires strong biologics manufacturing expertise, CMO/CDMO experience, project leadership capabilities and a highly customer-focused, solution-oriented mindset.

Job Description

Major Accountabilities

• Act as the technical project lead and single point of contact for biologics Drug Substance (DS) programs manufactured within the Novartis Contract Manufacturing network.
• Own customer DS projects end to end, from Business Development and contract handover through technology transfer, site onboarding, GMP execution and validation.
• Lead cross-functional teams across DS development, manufacturing, MS&T, Quality, Regulatory, Supply Chain, Engineering, and Commercial functions within the Novartis matrix organization.
• Translate contractual obligations and customer requirements into integrated project plans, governance, milestones, deliverables, and resource priorities.
• Ensure robust transfer and manufacturing readiness for mammalian and microbial DS processes.
• Drive delivery against customer commitments for quality, timelines, capacity, cost, and supply reliability, proactively managing technical, operational, regulatory, and commercial risks.
• Lead customer governance, including Joint Project Team and Joint Steering Committee meetings, and maintain trusted, transparent relationships throughout the contract lifecycle.
• Support change controls, deviations, investigations, CAPAs, regulatory submissions and inspections, and lifecycle improvements.

Minimum Requirements

• Bachelor’s, Master’s, or PhD in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related scientific discipline.
• Minimum 5+ years of biopharmaceutical experience, with substantial exposure to biologics Drug Substance development, manufacturing, MS&T, technology transfer, or CMC project leadership.
• Strong technical understanding of mammalian and/or microbial DS processes, including upstream and downstream operations, process validation, analytical control strategies, and manufacturing scale-up.
• Demonstrated experience in managing external customers and delivering against contractual scope.
• Sound knowledge of GMP manufacturing operations, quality systems, change control, deviation and CAPA management, and global regulatory expectations.
• Proven ability to lead complex, cross-functional DS technology transfers and manufacturing programs within a global matrix organization.
• Strong commercial awareness, including the ability to connect technical execution with contract scope, customer commitments, capacity, cost, and supply performance.
• Demonstrated ability to resolve complex technical and operational issues, drive timely decisions, manage risk, and maintain a strong customer- and delivery-focused mindset.

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

The rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits inkindto help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeingresourcesand global recognition programs. In addition, we provide flexible and hybrid working options, where possible, anda minimum of14 weekspaid parental leave.

Expected Annual Base Salary Range for role:85,900.00 - 159,500 EUR

The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochureto learn more about our global total rewards offering:https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

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 [e-mail] 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.

Commitment to Diversity and Inclusion / EEO paragraph:

Novartis is committed to building an outstanding, inclusive work environment and diverseteams’representative of the patients and communities we serve.

Skills Desired

Contract Management, Project Management