Manager, Manufacturing – J.POD Solution Prep and Mfg Ops Support

Just-Evotec is seeking a highly motivated Solution Prep and Mfg Ops Support Manager that desires a significant opportunity to improve worldwide access to biotherapeutics. 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 Prep, Facility Cleaning and other GMP support operations.  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 prep 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 disposable 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