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    Sr Mgr, Manufacturing Operations - Seattle, United States - Evote

    Evote
    Evote Seattle, United States

    4 weeks ago

    Default job background
    Description
    Senior Manager, Manufacturing

    Operations

    – J.POD Cell Culture
    The focus of this

    role

    is to guide the successful execution of upstream clinical and commercial manufacturing operations while ensuring cGMP compliance.

    This position

    is responsible

    for supervising and overseeing multiple shifts to cover 24/7 operation

    s

    and requires significant on-the-floor presence, as well as technical subject matter expertise in cell culture operations.

    Additional

    job responsibilities include generation and maintenance of cGMP manufacturing and technical documentation, troubleshooting and/or providing technical

    expertise

    to perform troubleshooting efforts or lead investigations, ensuring staff training and compliance, execution of plant start-up commissioning and validation activities, and implement

    ation

    and

    maintenance of

    required cGMP compliant systems

    .

    Th

    is individual may

    also

    participate

    in finite scheduling, aspects of technology and/or process transfer,

    identify

    process gaps and technology issues,

    determine


    solutions and remediation plans, provide support for regulatory and site inspections, and provide input to department capital and expense budgets.

    Responsibili

    ty level



    s:
    Provide

    expertise

    and make

    decisions that

    impact

    project teams brings in

    new technologies

    & literature

    "

    Use technical

    expertise

    to design/ implement new equipment, new disposable assemblies, or new molecule projects without guidance of prior protocols

    .

    Provide

    technical guidance to others within the company - develop new

    protocols

    H

    igh complexity, high (multi

    molecule)impact

    , challenging systems, coordinate interconnected systems/equipment, ID trends or

    non obvious

    issues/error traps/prevention

    Coordinate with leadership to

    i

    nitiate

    and lead new teams to

    address technical

    challenges "

    Communicate and/or present technical information to a diverse set of audiences, including senior management, regulatory agencies, and

    clients -

    bridge to Sr manager - more targeted communication

    Be

    a technical resource in multiple operational areas within functional group

    .

    Possess

    a deeper understanding of regulatory requirements

    .

    Contribute/ lead implementation of

    new technology

    or technical improvements

    .

    Represent Just

    externally

    Lead a

    Process or cross-company team. Lead investigations of operational/ quality issues. Lead

    and develop

    direct reports

    in the upstream functional areas

    with

    direct reports. SME for specialized areas (

    ex.training

    )

    Establish culture and hire to fit."

    Develop an emotionally intelligent organizational culture that values diversity, encourages open communication, and supports employee well-being.

    Supervise managerial tasks and team

    objectives

    .

    A

    pply emotional intelligence in negotiations, understanding the emotional needs of stakeholders, and finding mutually beneficial solutions.

    Consider the emotional impact of business decisions on various stakeholders, including employees, customers, and the community.

    Educational Requirement

    s:
    Master's degree and 6 years of Manufacturing or Operations experience; or

    Bachelor's degree and 8 years of Manufacturing or Operations experience

    Qualification

    requirement



    s:
    Proven knowledge of cGMP requirements to ensure

    compliance

    Significant experience

    in operations

    required

    for the manufacture of

    biotherapeutics

    Proven record of accomplishment managing,

    supervising

    and developing staff

    Candidate must

    possess

    strong focus on quality and attention to

    detail

    Excellent communication with senior leadership

    Possess effective task/time management organizational

    skills

    Capacity

    to develop solutions to technical issues of challenging

    scope

    Ability to organize, analyze/interpret, and effectively communicate data and

    results

    Motivated, self-starter with strong mechanical aptitude

    Good interpersonal, team, and communication skills are

    a

    must

    Significant contributor to multi-disciplinary teams at the functional level; mentors and

    provides

    technical advice to individuals within the

    team

    Excellent oral and written communication skills

    Additional Preferred Qualification

    s:
    In-depth knowledge of biotech equipment, operations, and engineering principles

    Recognized technical mastery of disposable manufacturing technologies at commercial

    scale

    Participation in client and regulatory agency audits

    Change control, NC/CAPA, and

    deviations

    Fundamental understanding and basic operation of process automation (

    DeltaV

    )

    Experienced in technology and/or process transfer for

    late stage

    clinical manufacturing or commercial qualification campaigns; commercial campaign support

    Application of knowledge and

    expertise

    to solve complex technical problems; may apply novel approach that provides significant technology

    advancement

    Active participation/lead technical projects with collaborators and vendors

    Experience with finite scheduling tools and allocation of resources and

    equipment

    This job description


    is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.

    It is not to be construed as an exhaustive statement of duties,

    responsibilities,

    or requirements.

    Because job requirements evolve with the changing needs of

    Just

    • Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.
    Evotec (US) Inc. is an Equal Opportunity Employer.

    All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

    #J-18808-Ljbffr
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