GCP Bioanalysis Team Lead: Director (Cambridge)

**380279BR** **Job ID:** 380279BR **About the role:** 5,600! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). NIBR’s global Translational Medicine group builds on basic research advances to develop new therapies that address unmet medical need. We are the crucial bridge between drug discovery and clinical application. Are you looking to build and grow your leadership opportunities? As a Director in the Translational Medicine Drug Disposition Bioanalytical group, you will have the opportunity to make a difference. If you have a collaborative nature, a commitment to teamwork across an organization and a relentless focus on improving patient care we want you to apply. In the Director role, you will use your leadership skills, scientific acumen, strategic mindset, and regulated bioanalysis experience to lead a team of global scientists in method development, validation and sample analysis focusing on our novel modality biologics portfolio. In setting the standard for operational excellence in a regulated bioanalytical lab - your main responsibilities will include but not be limited to: • Reviewing the strategic, operational, and technological aspects of the team and proposing modifications and improvements with a focus on continuous quality improvement and innovation. • Responsible for overseeing the scientific and regulatory compliance for all developed ligand binding, PCR, and mass spectrometry assays for pharmacokinetic and immunogenicity bioanalysis for all therapeutic modalities (proteins, mono, bi and tri-specific molecules, gene therapy, cell therapy, radioligand therapeutics and more). • Providing consultation and technical support for preclinical and clinical immunogenicity strategy discussions within Global Bioanalysis, and data interpretation consistent with current industry and health authority guidelines. • Contributing and reviewing relevant bioanalytical sections to regulatory and submission documents (e.g. IB, CTD). • Hire and lead a team of up to 30 scientists at multiple sites carrying out regulated bioanalytical sample analysis. The position will be based at our Cambridge, MA site and will not have the ability to be located remotely. The pay range for this position at commencement of employment is expected to be between $183,200 and $274,800/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. **Position Title:** GCP Bioanalysis Team Lead: Director (Cambridge) **Role Requirements:** What you will bring to the role: • M.S. or Ph.D. with significant and relevant (10+ years) GCP experience in a pharmaceutical, CRO or related industry. • Demonstrated experience leading a regulated biologics BA team. • Hands-on experience with the development of ligand binding, mass spectrometry and/or PCR assays with the proven ability to develop BA strategies across a variety of modalities using different technologies. • Strong engagement, interpersonal communication skills and ability to work in a dynamic matrix environment with frequently shifting priorities and timelines. • A thorough understanding of industry landscape and Health Authority guidelines. • Demonstrated success building, leading and developing a team of experienced scientists. • Experienced in writing and supporting others contributing to the bioanalytical sections of regulatory and submission documents. • Demonstrated success moving a strategy from ideation to completion with advanced stakeholder management. Why consider Novartis? 736 million. That’s how many lives our products touched in 2022. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Flexibility: Novartis offers a flexible working environment for lab-based associates Culture: Novartis is a curious, empowered, inspired, unbossed, collaborative environment Growth and development: Associates are encouraged to take ownership of their growth and development with several cross-functional development (technical and leadership) options to explore Total rewards: Novartis offers competitive: salaries, short and long-term incentives, health and retirement options, paid-time off, and many other benefits Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities,join the Novartis Network here: https://talentnetwork.novartis.com/network. **Job Type:** Full Time **Country:** USA **Work Location:** Cambridge, MA **Functional Area:** Research & Development **Division:** Novartis Institutes for BioMedical Research **Business Unit:** Translational Medicine **Employment Type:** Regular **Company/Legal Entity:** NIBRI **Commitment to Diversity & Inclusion::** _The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._ **Shift Work:** No **Early Talent:** No