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 :

Masters degree and 3 years of Manufacturing & Operations experienceBachelors degree and 5 years of Manufacturing & Operations experienceAssociates degree and 10 years of Manufacturing & Operations experienceHigh school diploma / GED and 12 years of Manufacturing & Operations experienceQualification Requirements :Proven knowledge of cGMP requirements to ensure complianceSignificant experience in solution preparation and facility cleaning operations as required for the manufacture of biotherapeuticsProven record of accomplishment managing, supervising, and developing staffCandidate must possess strong focus on quality and attention to detailPossess effective task/time management organizational skillsCapacity to develop solutions to technical issues of moderate scopeAbility to organize, analyze/interpret, and effectively communicate data and resultsMotivated, self-starter with strong mechanical aptitudeGood interpersonal, team, and communication skills are a mustExcellent oral and written communication skillsAdditional Preferred Qualifications :In-depth knowledge of solution prep and facility cleaning.

Recognized technical mastery of single-use manufacturing technologies at commercial scaleParticipation in client and regulatory agency auditsExperience with finite scheduling tools and allocation of resources and equipmentChange control, NC/CAPA, and deviationsFundamental 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 plusApplies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancementSignificant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the teamActive participation/lead technical projects with collaborators and vendorsThis 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.

FR :
Dans le cadre de sa politique Diversite, Evotec etudie, a competences egales, 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.#J-18808-Ljbffr