Senior Expert Technical Development- Drug Product Project Lead at Novartis
East Hanover, NJ 07936
About the Job
Job Description Summary#LI-OnsiteAs a Cell Therapy Process Development Drug Product Project Lead (DP-PL) you will be accountable for Drug Product-related project activities
In this role you will lead, manage, coach and support the project sub-team by fostering a culture of innovation, empowerment, trust, learning, diversity and inclusion
As a DP-PL you will support the Novartis pipeline programs, representing Process Development function, operating as a single point of contact for Drug Product in cross-functional CMC Team; you will have a complete oversight of Drug Product related activities and you will retain accountability for DP-related project strategy and deliverables within your functional area.Job DescriptionMajor accountabilities: Leads the discipline sub-team, acts as a project manager and is accountable for all project activities within Process Development Drug Product line unit
Owns the discipline project strategy in alignment with the technical development plan (TDP), and represents the project sub-team discipline in the CMC team as a core member
Sets priorities and objectives within the DP sub-team in alignment with the TDP and the CMC objectives and updates CMC team on technical issues, risks and mitigation strategies.Oversees the study design, provides guidance to functional leads (FLs) ensuring adherence to project development strategy; is accountable and responsible to define the DP control strategy
Tracs project progress according to defined timelines, identifies roadblocks/risks and issues, develops solutions and mitigation plans/scenarios if required and proactively reports them to respective stakeholders and governance boards (e.g
CMC project teams, line function management, affected line function discipline(s) and other relevant project boards).Compiles and provides financial forecast for project-specific development activities needed to reach the program milestone.Manages project specific compliance aspects (e.g
change notifications, deviations).Assesses, consolidates and monitors resource needs and timelines for assigned projects and ensures resources are accurately reflected in the planning systems
Ensures DP development is compliant with quality principles and cGMP practice; is accountable for coordination and timely delivery of high-quality source documents for HA submissions, review of regulatory documents (e.g
CMC modules, briefing books); provides content to/is responsible for answers to HA questions or Investigator Brochure
Stays at the forefront of the scientific and technical trends in his/her discipline through literature and participation in conferences and workshops
Minimum Requirements: University degree in biotechnology, pharmaceutical technology or similar discipline5-6 years (BS), 2-4 years (MS) or 0-3 years (Ph.D.) of related experience with pharmaceutical development (Drug Product)
Thorough understanding of development processes, good knowledge of state-of-the-art technology/equipment, and knowledge of related basic regulations
Project excellence: Navigating through complexity and ambiguity, strong communication & presentation and organization and planning skills, excellent time management and planning abilities; inclusive in a decision-making process, strong leadership skills in a matrix set-up.Operational excellence: Demonstrates cross-functional problem-solving, critical data evaluation, continuous improvement mindset; advanced coaching and proven leadership skills
Organizational Savvy: Understanding organizational structures, working practices and strategy
Inclusive and collaborative across disciplines and geographies, excellent networking and relationship building
Stakeholder engagement: Excellent communication, negotiation, and interpersonal skills
Ability to work in interdisciplinary and cross-cultural teams; confident in managing expectations and conflict management
Business mindset: strategic thinking and planning, confident with risk management including quality & safety, resources and budget planning
Vision and Purpose: a role model to the functional team for creating a shared purpose; priorities and objectives settingThe pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 /year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.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?
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.Skills: Coaching Skills.Data Science.Environment.Experiments Design.Health And Safety (Ehs).Laboratory Equipment.Manufacturing Process.Materials Science.Process Simulation.Project Management.Sop (Standard Operating Procedure).Technical Writing.EEO Statement:The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status
We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.Accessibility and reasonable accommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to
Please include the job requisition number in your message.Salary Range$124,000.00 - $186,000.00Skills DesiredCoaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Project ManagementSummaryLocation: East Hanover; Cambridge (USA)Type: Full time
In this role you will lead, manage, coach and support the project sub-team by fostering a culture of innovation, empowerment, trust, learning, diversity and inclusion
As a DP-PL you will support the Novartis pipeline programs, representing Process Development function, operating as a single point of contact for Drug Product in cross-functional CMC Team; you will have a complete oversight of Drug Product related activities and you will retain accountability for DP-related project strategy and deliverables within your functional area.Job DescriptionMajor accountabilities: Leads the discipline sub-team, acts as a project manager and is accountable for all project activities within Process Development Drug Product line unit
Owns the discipline project strategy in alignment with the technical development plan (TDP), and represents the project sub-team discipline in the CMC team as a core member
Sets priorities and objectives within the DP sub-team in alignment with the TDP and the CMC objectives and updates CMC team on technical issues, risks and mitigation strategies.Oversees the study design, provides guidance to functional leads (FLs) ensuring adherence to project development strategy; is accountable and responsible to define the DP control strategy
Tracs project progress according to defined timelines, identifies roadblocks/risks and issues, develops solutions and mitigation plans/scenarios if required and proactively reports them to respective stakeholders and governance boards (e.g
CMC project teams, line function management, affected line function discipline(s) and other relevant project boards).Compiles and provides financial forecast for project-specific development activities needed to reach the program milestone.Manages project specific compliance aspects (e.g
change notifications, deviations).Assesses, consolidates and monitors resource needs and timelines for assigned projects and ensures resources are accurately reflected in the planning systems
Ensures DP development is compliant with quality principles and cGMP practice; is accountable for coordination and timely delivery of high-quality source documents for HA submissions, review of regulatory documents (e.g
CMC modules, briefing books); provides content to/is responsible for answers to HA questions or Investigator Brochure
Stays at the forefront of the scientific and technical trends in his/her discipline through literature and participation in conferences and workshops
Minimum Requirements: University degree in biotechnology, pharmaceutical technology or similar discipline5-6 years (BS), 2-4 years (MS) or 0-3 years (Ph.D.) of related experience with pharmaceutical development (Drug Product)
Thorough understanding of development processes, good knowledge of state-of-the-art technology/equipment, and knowledge of related basic regulations
Project excellence: Navigating through complexity and ambiguity, strong communication & presentation and organization and planning skills, excellent time management and planning abilities; inclusive in a decision-making process, strong leadership skills in a matrix set-up.Operational excellence: Demonstrates cross-functional problem-solving, critical data evaluation, continuous improvement mindset; advanced coaching and proven leadership skills
Organizational Savvy: Understanding organizational structures, working practices and strategy
Inclusive and collaborative across disciplines and geographies, excellent networking and relationship building
Stakeholder engagement: Excellent communication, negotiation, and interpersonal skills
Ability to work in interdisciplinary and cross-cultural teams; confident in managing expectations and conflict management
Business mindset: strategic thinking and planning, confident with risk management including quality & safety, resources and budget planning
Vision and Purpose: a role model to the functional team for creating a shared purpose; priorities and objectives settingThe pay range for this position at commencement of employment is expected to be between $124,000 and $186,000 /year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.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-cultureBenefits
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-rewardsCommitment
to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environmentWe 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.Skills: Coaching Skills.Data Science.Environment.Experiments Design.Health And Safety (Ehs).Laboratory Equipment.Manufacturing Process.Materials Science.Process Simulation.Project Management.Sop (Standard Operating Procedure).Technical Writing.EEO Statement:The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives
We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status
We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.Accessibility and reasonable accommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to
us.reasonableaccommodations@novartis.com
or call +1(877)395-2339
and let us know the nature of your request and your contact informationPlease include the job requisition number in your message.Salary Range$124,000.00 - $186,000.00Skills DesiredCoaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Project ManagementSummaryLocation: East Hanover; Cambridge (USA)Type: Full time
