Associate Director, Laboratory Informatics

The Role

Moderna is seeking an Associate Director, Laboratory Informatics based at their Norwood, MA site.

The individual in this role will oversee the laboratory digital lifecycle for the Moderna QC team at the Norwood Site, which includes coordinating new installation qualification, periodic ordinary and requalification activities for all QC instruments software in the QC Norwood Campus, guarantying business continuity and proper governance of the QC digital lifecycle. The individual will be responsible for coordinating across multi-discipline teams (including external service providers) to meet business objectives and act as a laboratory informatics SME for Investigations for Quality Events.

Heres What Youll Do

• As the leader of the QC Laboratory Informatics team, your primary responsibilities will be as follows:

  • Leading and mentoring a dynamic team that is responsible for all digital software implemented in the QC lab

  • Serve as an active member of the Quality Control Leadership Team (QCLT) supporting the digital needs of QC laboratories including Microbiology, Bioassay, Chemistry, Raw Materials, and Sample Management departments

  • Ensure all laboratory software, validation (DQ/IQ/OQ/PQ), and data integrity are compliant with 21CFR Part 11 and Annex 11

  • Keep the laboratory software in a constant state of readiness according to cGMP guidelines and minimize software downtime

  • Work closely with Equipment team, business owners, understanding of laboratory workflow and incorporate that understanding into the evolution and support of the software systems

  • Developing meaningful Key Performance Indicators for laboratory software status and usage

  • Oversee the implementation, use and maintenance of interfaces between laboratory operation and Enterprise software

  • Responsible for laboratory digital project organization, including defining project requirements, developing project plans, organizing project staff, and establishing realistic timelines

  • Work with lab personnel and other stakeholders to optimize the digital processes to improve integration and coordination between IT Digital and Laboratory requirements

  • Ensure the QC Informatics team to provide prompt support to lab in terms of software questions, and QC digital tickets, etc. to meet project timelines.

  • Serve as the point person in QC for all laboratories digital inquiries and relay to appropriate vendors and internal cross functional teams

  • Monitor and communicate software upgrades timelines using project management tools to minimize the impact to lab operation and improve efficiency

  • Responsible for external service providers oversight and ensuring adherence to Moderna policies and procedures

  • Responsible for the quality systems records related to Laboratory Informatics such as data integrity, deviations, change controls, CAPAs, Proactive Initiatives, etc. from start to finish

  • Provide digital software assessments for QC as a Subject Matter Expert

  • Author, review and approve documents including, but not limited to URS, CDS, FRS, Risk Assessment, DQ, IQ, OQ, PQ, Discrepancy investigation, SOPs, etc.

  • Responsible for maintaining vendor contracts and purchase orders

  • Establish training and ensure QC Digital and laboratory staff are properly trained for software applications.

  • May include off hour support to assist QC shifts

  • Additional duties as may be assigned from time to time

Heres What Youll Need (Minimum Qualifications)

• Minimum education required: Bachelors degree in relevant sciences and 15 years of industry experience in a cGMP setting. Level determined by experience.

Heres What Youll Bring to the Table (Preferred Qualifications)

• Strong technical background in laboratory software validation and data integrity,

• Demonstrate ability to problem solve, organize, and see-through project timelines independently.

• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

• Strong technical writing skills, oral communication, and organizational skills.

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment

• Knowledge of both Microbiology and Chemistry equipment software application preferred

• Experience with Choromeleon and LabVantage

• Prior experience with lab relocation projects a plus

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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