QC Senior Stability Specialist

Novavax Gaithersburg , MD 20877

Posted 2 weeks ago

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

We are expanding our internal Quality Control capabilities in support of our promising SARS-COV-2 Vaccine and we have a Senior Stability Specialist position that we are seeking to fill with a candidate that is ready to contribute to a growing team in support of this exciting and important program. The Senior Stability Specialist will be a member of the Quality Control Department reporting into the Senior Stability Manager, Quality Control. The QC Senior Stability Specialist will work collaboratively with internal and external teammates in Quality, Manufacturing, and Supply Chain to manage stability programs across several external partners while assisting with the establishment of internal stability capabilities/programs.

Job Overview:

The primary focus of the role will be to support all vaccine stability programs from clinical development through commercialization by providing quality oversight and management of cell banks, virus stocks, drug substance drug product intermediates, and drug products.

Primary Responsibilities include but are not limited to:

  • Execute day to day operations of the stability program through data compilation/analysis, and authoring/ review/ approval of protocols and reports

  • Provide oversight to CMOs/CTLs to ensure that studies conducted externally are executed compliantly and on time

  • Responsible for the resolution and on-time completion of stability-related deviations, CAPAs, and Change Controls by providing technical expertise, as appropriate.

  • Responsible for generating, updating, and retiring stability-related SOPs, as appropriate.

  • Responsible for ensuring that the stability-related forms / documents adhere to GXP requirements and Novavax' internal SOPs.

  • Represent QC Stability on cross functional meetings/teams

  • Other duties as assigned.

Basic Qualifications:

  • Bachelor in a Life Sciences discipline or equivalent experience plus 8 or more years of relevant experience in a GxP environment with at least 3 years of Stability experience in a GMP regulated environment.

  • Scientific background in analytical methods and stability of Biologics

  • Experience in writing SOPs, investigations, stability protocols and reports as well as annual product performance reports.

  • Experience with LIMS, QMAS (or similar), and statistical software (.JMP) is preferred.

  • Experience interfacing with CMOs/CTLs

  • Possess excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines

  • Possess excellent customer service skills and have strong verbal and written communication skills

  • Strong attention to detail

  • Effective Problem Solving

  • Ability to work independently and carry out tasks with general instruction

  • Ability to work in a dynamic and fast paced team environment

  • Fundamental Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products

Preferred Qualifications:

  • Experience with QMAS and JMP
    • Experience working with external suppliers: CMOs/CROs/CTLs

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Stability Specialist

Catalent Pharma Solutions, Inc.

Posted 2 months ago

VIEW JOBS 9/19/2020 12:00:00 AM 2020-12-18T00:00 Job Description Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here Catalent Cell & Gene Therapy is looking to recruit a Stability Specialist to join our growing team in Gaithersburg, MD. Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. The Stability Specialist role is critical to our patients. Manufacturing life-saving medicines right the first time for themselves and their team with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role! The Stability Specialist is responsible for day-to-day operations related to the Stability Program at the Montgomery site. The candidate must possess excellent time management skills, ability to manage multiple projects, and a proven history of working successfully in a team environment. The Role * Execute day-to-day operations of the Stability Program to support Analytical Development and Quality Control ensuring a timely, effective and compliant operation to meet project requirements * Manage the department's stability program which requires a solid working knowledge of the stability testing requirements for each project * Pull, submit and distribute samples for testing to appropriate personnel/ laboratories, and track timely completion of testing * Review data packages to ensure documentations are in accordance to department and company procedures * Author stability protocols and summary reports; drive the approval process to meet or exceed specified timelines * Participate in client and internal working groups and investigational meetings related to stability * Interact effectively and professionally with members from multiple departments across the organization The Candidate * Master's degree or equivalent in a scientific discipline * Minimum of 4-6 years' experience in a cGMP laboratory, preferably related to pharmaceutical industry with a Quality focused background * Candidate should have a good understanding of relevant regulatory/industry standards and requirements * Good understanding of analytical test methods such as RP-HPLC, ELISA, CE, SDS-PAGE, general wet chemical techniques Catalent's standard leadership competencies that are used to interview and for Performance & Development * Leads with Integrity and Respect * Delivers Results * Demonstrates Business Acumen * Fosters Collaboration and Teamwork * Champions Change * Engages and Inspires * Coaches and Develops Position Benefits * Potential for career growth within an expanding team * Defined career path and annual performance review & feedback process * Cross functional exposure to other areas of within the organization * Medical, Dental, Vision, and 401K are all offered from day one of employment * 19 days of paid time off annually + 7 paid holidays Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit www.catalent.com/careers to explore career opportunities. Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Catalent Pharma Solutions, Inc. Gaithersburg MD

QC Senior Stability Specialist