Manufacturing Manager - Nights, Site Based, Redmond, WA

Manager, Manufacturing Operations - Purification

This position will be responsible for supervising a shift to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in purification 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, execution of plant start-up commissioning and validation activities, 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.

Educational Requirements:

Master's degree and 3 years of Manufacturing or Operations experience; or

Bachelor's degree and 5 years of Manufacturing or Operations experience

Qualification Requirements:

Knowledge of cGMP requirements to ensure compliance

Significant experience in purification operations required for the manufacture of biotherapeutics

Candidate must possess strong focus on quality and attention to detail

Execute downstream technology strategies from bioreactor recovery, chromatography column purification, impurity removal, viral inactivation and filtration, UF/DF, and sterile filtration

Excellent communication with senior leadership

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

May lead cross-functional teams within and external to Just. May be a core department lead in NPI.

Responds to equipment alarms.

Excellent oral and written communication skills

Additional Preferred Qualifications:

Proven record of accomplishment managing, supervising and developing staff

In-depth knowledge of purification equipment, operations, and engineering principles

Recognized technical mastery of disposable manufacturing technologies at commercial scale

Participation in client and regulatory agency audits

Uses technical depth and breadth to develop solutions to deviation investigations, leads CAPA projects, or coordinates more in depth troubleshooting issues where vendors may be involved.

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

The base pay range for this position at commencement of employment is expected to be $100,000 to $150,000; base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits

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.