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    Senior Vice President, Community Operations - Alameda, CA, United States - Scribe

    Scribe
    Scribe Alameda, CA, United States

    Found in: Jooble US O C2 - 1 day ago

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    Description

    Scribe Therapeutics is a molecular engineering company focused on creating best-in- class in vivo therapies that permanently treat the underlying cause of disease.

    Founded
    by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl,
    David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current
    genome editing technologies by developing custom engineered enzymes and delivery
    modalities as part of a proprietary, evergreen CRISPR by Design platform for CRISPR- based genetic medicine.

    We are seeking a highly creative, passionate, and motivated individual to join us in our
    quest to develop the next generation of CRISPR-based therapeutics. The current role is
    for a Vice-President, Quality Assurance/Quality Control to join the Scribe's leadership
    team and advance Scribe's platform. The candidate should have a passion for working
    collaboratively to enable building the necessary delivery platform to meet the new
    frontier of CRISPR-based therapeutics. Additionally, the candidate would bring with
    them quality mindset, ability to influence across the organization, and ingenuity to
    develop fit-for-purpose quality processes.
    The candidate will have the opportunity to build their team in a rapidly growing
    biotechnology start-up and the ability to bring the next generation gene editing drug
    products to the patients.


    Key Responsibilities:

    • Collaborate with senior leadership to provide strategic and technical guidance of Quality
    Assurance activities and outcomes. You'll lead with a culture of Quality by conceiving,
    collaborating, and supporting the implementation of specific actions, processes, and behaviors

    • Provide strong strategic leadership for CMC QA at Scribe in support of Good Manufacturing
    Practices (GMPs) with significant operational and quality experience

    • Help to implement, monitor, and promote good practice of all Quality Assurance Systems to
    ensure compliance with relevant FDA, EMA/other regulations/directives/requirements and ICH
    guidelines

    • Establish and oversee required phase-appropriate GxP systems
    ○ Utilize GMP-regulated quality management systems and eQMS, including document
    control, change control, deviations/complaints, DS/DP release and CAPAs.
    ○ Develop and implement a common platform of quality and compliance systems, tools,
    procedures, and standards company-wide
    ○ Establish required phase-appropriate GxP systems for Scribe, including prioritization,
    and timeline oversight
    ● Evolve, audit, and monitor Standard Operating Procedures (SOPs) to ensure they are in
    accordance with GxP guidelines. Carry out corrective actions for identified deviations
    ○ Design, develop, and review CMC QA standards and procedures (i.e., policy documents
    and SOPs). Review and support deployment of Quality Standards generated by the
    Quality System Department.
    ● Provide independent oversight and compliance direction with authority for CMC Quality and
    product disposition, including CDMO's, CMOs and Packaging Facility
    ○ Ensure completeness of technical evaluation and quality due diligence activities in
    support of CDMO/CRO site selection process
    ○ Provide stewardship of the quality risk profile and team risk log, and approve risk
    controls strategies at CDMOs/CROs both in the selection and manage phases.
    ○ Review Quality Agreements, Master Service Agreement and protocols for CDMOs and
    CROs to implement in order to ensure requirements for regulatory filing
    ○ Drive process and product quality through effective CMC quality systems, ensuring
    adequate supplier oversight/surveillance
    ○ Approve Protocol and Reports, Master Batch Records and Executed Batch Records at
    the CDMO and the CROs for Filling and Packaging
    ○ Ensure that all necessary steps are added to the Process Control Strategy
    ○ Review and verify process data to assure compliance with data integrity and traceability
    regulatory requirements as appropriate
    ○ Disposition (approve/reject) batches for release
    ○ Ensure that all products manufactured meet the registration and cGMP requirements
    based on global regulatory requirements.
    ○ Ensure that Scribe and our partners are inspection-ready for health authority audits by
    regulatory agencies; lead engagements with health authorities

    • Accountable for training and education on GxPs and SOPs company-wide
    • Accountable for the preparation and conduct of all inspections by any regulatory authority
    ○ Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs,
    Annual Reports); ensure compliance with regulatory procedures. Strategize responses to
    regulatory questions during review period and product lifecycle.
    ○ Provide direct oversight of activities related to participation in U.S. FDA (CBER) and
    other regulatory agency inspections

    • Assume leadership roles in CMC teams
    • Collaborate with CMC Leads and Portfolio Management partners to ensure successful planning,
    execution and delivery of projects.
    ● May participate in external collaborations to influence policy, practices and current guidance for
    the manufacture of biologics, small molecules and novel therapeutics.

    Required Skills and Background:

    • Minimum 15 years of experience in the biotechnology industry and at least 7 years in a Quality
    leadership role. Bachelor's degree in a scientific field or relatable field required; Master's or
    Ph.
    D. a plus

    • Experience with GMP requirements and with US and International regulatory authority
    inspection requirements

    • Success in collaborating on IND, BLA/NDA, and MAA submissions for novel products
    • Relevant knowledge and experience base working with research and development and
    manufacturing groups on quality issues is required.
    ○ A strong experience based on global GMP, QA, and QC issues pertaining to biologics is
    required.
    ○ Expertise in aseptic manufacturing is required.
    ○ In-depth knowledge of FDA, EU and International regulations, EU, and US compendial
    requirements and industry best practices regarding documentation systems, design
    control, change control, product specifications, and cGMP.
    ● Demonstrated, hands-on approach to building a successful quality organization in a startup
    environment preferred.

    • Excellent communication, leadership, and collaboration skills.
    • Flexible and able to adapt to company growth and evolving responsibilities.
    • Ability to develop CMC QA vision and mission and inspire team to realize department vision and
    mission.

    • Demonstrate quality mindset and influences across the entire organization.
    • Ability to manage budget and resourcing and to lead a department.
    • Knowledge and experience negotiating quality agreements.
    • Flexibility and the ability to manage change.
    • Strong interpersonal skills and the ability to work well as part of a team.
    • Exceptional verbal and written communication skills.
    • Demonstrated ability for analytical and systematic thinking.
    • Proficient in risk assessment and root cause analysis tools.
    • Ingenuity to develop quality processes that fit virtual DS and DP product manufacturing
    operations for novel therapeutics.

    Preferred Skills and Background:
    ● Familiarity with CRISPR technologies and therapeutic approaches

    • Some familiarity with oligonucleotide and lipid interactions that might effect delivery
    • Knowledge of clinical and commercial supply chain
    Salary will be commensurate with experience. We will provide an intellectually
    stimulating, collegial and fast-paced environment. If you are ready to engineer the
    future of therapeutics, then we are excited to hear from you Visit us at
    .

    We are committed to creating a diverse environment and are proud to be an equal
    opportunity employer. All qualified applicants will receive consideration for
    employment without regard to race, color, religion, gender, gender identity or
    expression, sexual orientation, national origin, disability, age, or veteran status.
    At the time of posting, the base pay wage range for this role will vary according to experience.

    The offered pay range will depend on internal equity and the candidate's relevant skills, experience, qualifications, training, and market data.

    Additional incentives are provided as part of the complete package in addition to comprehensive medical and other benefits.
    #J-18808-Ljbffr
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