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Manager, Manufacturing Operations - Raleigh, United States - Evote
Description
The focus of this job is to guide the successful execution of clinical and commercial manufacturing operations while ensuring cGMP compliance.
This position will be responsible for supervising and overseeing Day/Swing/Night shifts and to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in Solution Preparation, Facility Cleaning and other GMP support operations, including component preparation and sterilization.
Additional job responsibilities will 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 and implement and maintain required cGMP compliant systems.
The manager 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.
Basic Qualifications :
Master's degree and 3 years of Manufacturing & Operations experience
Bachelor's degree and 5 years of Manufacturing & Operations experience
Associate's degree and 10 years of Manufacturing & Operations experience
High school diploma / GED and 12 years of Manufacturing & Operations experience
Qualification Requirements :
Proven knowledge of cGMP requirements to ensure compliance
Significant experience in solution preparation and facility cleaning operations as 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
Possess effective task/time management organizational skills
Capacity to develop solutions to technical issues of moderate 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
Excellent oral and written communication skills
Additional Preferred Qualifications :
In-depth knowledge of solution prep and facility cleaning.
Recognized technical mastery of single-use manufacturing technologies at commercial scale
Participation in client and regulatory agency audits
Experience with finite scheduling tools and allocation of resources and equipment
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 is a plus
Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team
Active participation/lead technical projects with collaborators and vendors
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.
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.
FR :
Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG :
In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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