Senior Analyst, Quality Control (Biochemistry-Day Shift)

Location
Durham, NC, US
Posted
Feb 20, 2021
Ref
5850
Hotbed
Bio NC
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 Senior Analyst, Quality Control assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production.

Responsibilities
  • Executes routine and non-routine analysis, including but not limited to raw materials, in-process items and finished product according to established operating procedures.
  • Responsible for broader range of laboratory support functions and procedures as assigned, developing capability in advance technical skills, disciplines, and procedures within assigned discipline area(s).
  • Ensures assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook/equipment use and maintenance, and updates to existing and authors new operating procedures.
  • Capable of delivering to assigned work schedule with attention to detail and accuracy.
  • Notifies management, initiates (such as Laboratory Investigations) and authors minor events/discrepancies in the quality systems, with little to no guidance from advisor or management.
  • Leads special projects on analytical and instrument problem solving by execution of assay. May develop testing and analysis methods and procedures in accordance with established guidelines.
  • Understands the basic process improvement methodologies, learning and applying concepts of lean lab and six sigma that are applicable to the QC lab environment.
  • May facilitate training to other team members in the organization.
  • Ensures calibrates and maintains lab and analytical equipment are performed within established period.
  • Conducts review of logbooks and may perform reviews as assigned by management
  • May assist in drafting technical documents such as Protocols / Report to support method verification/validations.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 2 years' experience in GMP environment.
  • Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
  • Builds productive internal/external working relationships.
  • Excellent interpersonal, verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
  • Proficient in Microsoft Word, Excel, Power Point and other applications.
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.
  • Ability to gown for entry into Aseptic core and supporting areas and lift approximately 25 pounds.


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

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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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