Specialist, Technical Analytical Development - Lab

Location
San Diego, CA, US
Posted
Nov 21, 2020
Ref
5727
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Specialist, Technical Analytical Development - Lab, provides technical expertise to the method development teams.

Responsibilities
  • Computerized system owner/ administrator for Analytical Development (AD) Lab systems.
  • Plans and leads projects to purchase, onboard and commission AD instruments and systems.
  • Works with AD End Users, Quality, IT and Engineering to support computerized system lifecycle management activities from concept, development, commissioning, implementation, modification, troubleshooting and maintenance to retirement.
  • Supports base site and supports a harmonized approach with team members across all network sites.
  • Authors and reviews protocols, reports, investigations, non-conformance, CAPAs, change management and other records related to AD computerized systems.
  • Monitors AD computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.
  • Assists with data integrity initiatives as they relate to AD computerized systems.
  • Leads periodic reviews of existing computerized systems and identify process improvements.
  • Coordinates implementation of new processes.
  • Creates/maintains SOP's/ WI's and training related to AD systems.
  • Represents automation during meetings. Communicates and tracks all follow-up items through to completion.
  • Provides oversight or participation on all aspects of future projects including integration of instruments to control networks, data backups and data retention.
  • Prepares scopes of work and manage vendors as required to complete required work on within project timelines.
  • Develops project objectives working with user requirement and business plans.
  • Determines equipment or system specifications and most cost-effective technology to be implemented
  • Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information.
  • Establishes equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
  • Takes programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools.
  • Maintains procedures to meet quality requirements, CFR's and internal company policies.
  • Participates and/or leads new method transfers to ensure smooth transition from analytical development into commercial QC.
  • Supports 24x7 site-based operations after startup.
  • Analyzes and interprets data and make sound technical recommendations on continuous improvements and non-conformance remediations.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's degree in Engineering, Computer Science or IT field of with 5 years relevant experience working in a GxP pharma or biotech environment preferred.
  • 3 years' experience in administration of lab instruments.
  • Experience with NGS pipeline preferred.
  • Familiarity with Windows permission settings, network domain, and a general understanding of server architecture.
  • Prefer familiarity with SQL, Java, or other programming languages.
  • Experience in system level validation testing.
  • Experience writing and executing change controls.
  • Able to develop MS SQL queries.
  • In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
  • Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality driven processes and end products.
  • Excellent oral and written communication skills.
  • Experience managing 3rdparties (both in-sourcing and outsourcing).
  • Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.
  • Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
  • Provide technical support on all issues when driving towards issue resolution.
  • Experience should include lifecycle management of Quality computerized systems.
  • Up to 10% travel.


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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