What are the responsibilities and job description for the Validation Lead position at Novartis?
Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.
Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
Location: On-site
The Validation Lead is responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are aligned with Regulatory Authorities’ expectations and related SOPs.
Stewardship:
Validation:
Launch & Transfer:
Training:
Novartis Manufacturing Manual:
The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.
Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
Location: On-site
The Validation Lead is responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are aligned with Regulatory Authorities’ expectations and related SOPs.
Stewardship:
- Support Product Steward in maintaining the process control strategy.
- Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
Validation:
- Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
- Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
- Ensure that all manufacturing and cleaning processes are validated, overview on state of validation at site is maintained.
- Establish and monitor validation critical metrics.
- Maintain all validation activities in an inspection ready status.
- Reviews risk assessments for validation and OPV, provide guidance to facility impact and component criticality assessments.
- Author complex validation protocols.
- Establish local procedures & templates for respective validation documentation.
- Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
- Provide technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.
- Be a senior advisor in case of difficult validation challenges at Site.
- Host validation council.
- Support Site MS&T Head in ensuring that responsible departments execute and maintain the VMP activities.
- Partner with Engineering, IT, QC, AS&T to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation.
Launch & Transfer:
- Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Provide technical expertise for pre-validation / validation strategy.
- Contribute to providing experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
Training:
- Own the Training Curriculum for own Profile and direct reports.
Novartis Manufacturing Manual:
- Support implementation of Novartis Manufacturing Manual principle 3.
- Represent site in validation network.
The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.
EEO Statement
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.
Minimum requirements
- BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent.
- 6 years of proven experience in manufacturing / manufacturing science and/or technology / technical development / quality.
- Previous aseptic manufacturing experience is required.
- Thorough understanding of manufacturing processes and related process equipment.
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Experience in completing process validation, having led and managed validation projects.
- Expert in reviewing and writing technical reports.
- Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
- Fundamental understanding of standard pharmaceutical analytical testing.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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.
Accessibility and Reasonable Accommodations:
The 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.
Division
Operations
Business Unit
Radio Ligand Therapy
Country
USA
Work Location
Indianapolis, IN
Company/Legal Entity
AAA USA Inc.
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
Salary : $118,400 - $177,600