What are the responsibilities and job description for the MS&T Specialist position at Novartis?
The MS&T Specialist supports MS&T team on sites by collecting data, reviewing or writing technical documents related to validation (e.g. process validation, ongoing process verification, cleaning validation, packaging), APR PQR, technical files, product risk assessment procedures and maintaining a product oversight throughout the lifecycle.
The pay range for this position at commencement of employment is expected to be between $59,900 and $89,900 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
- Support Validation program including process validation, ongoing process verification (OPV), risk assessments. Create validation documentation including process validation protocol/reports, risk assessment, ongoing process verification (OPV) plans/ reports, cleaning validation protocol/reports based on alignment with Site Validation Lead.
- Using monitoring tool such as OPV Monitor or Discoverant perform, OPV evaluations, assess process performance and provide insight, recommendation, and conclusion to the site MS&T Lead/Product Steward.
- Create and review GxP documents including SOPs, working procedures, trend reports, and technical investigations, as and when needed.
- Support tasks related to technical changes, incident investigations for the product and process. Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports. Coordinate & manage project for a smooth knowledge transfer activity from site/ function to Operations Center.
- Act as single point of contact for the services delivered to sites/ functions by the respective team, including the review of feedback and timely completion of identified actions.
- Coordinates documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable.
- Obtains deviation reports from relevant systems in support to validation to enable conclusions.
- Coordinates and owns DI check with Data integrity manager where applicable.
- Coordinates inputs from respective functions (QA, QC, MS&T), to create the validation documents and decide on the study strategy.
- Coordinates the execution of the study with respective functions. Collects results and creates reports.
The pay range for this position at commencement of employment is expected to be between $59,900 and $89,900 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 Pharmacy, Pharmaceutical Technology, Chemistry, Chemical engineering, or equivalent scientific degree.
- Minimum of 1 year experience in process support, e.g. Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Validation and Regulatory aspects).
- Sound experience of data handling and applied statistics is a must.
- Strong understanding of risk assessment and risk management fundamentals/tools
- Team building and process harmonization skills
- Excellent verbal and written communication skills
- Excellent problem solving and decision-making skills
- Defining and implementing productivity improvement measures.
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.
Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for Covid-19 or proof of a recent negative test result for Covid-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com
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
ONCOLOGY
Business Unit
ADVANCED ACCELERATOR APPLICATIONS
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
Yes
Early Talent
Yes
Salary : $59,900 - $89,900
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