Sr Manager, Manufacturing Compliance

3 weeks ago

Redmond, United States Evotec SE Full time

Job Description: Sr Manager, Manufacturing Compliance

Just is seeking a highly motivated manager of the manufacturing technical support team that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful logistical support for quality records for clinical and commercial manufacturing operations while ensuring cGMP compliance. This position will responsible for supervising a team of technical subject matter expertise in biologics operations.

Qualifications:

* BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering) with a minimum 10 years of experience in a GMP manufacturing environment
* Minimum 4 years of hands-on experience in fermentation, purification or pharmaceutical manufacturing process
* Minimum 4 years of managerial experience guiding teams in a GMP environment
* Proven knowledge of cGMP requirements to ensure compliance
* 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
* Strong proficiency in Microsoft Word, Excel, PowerPoint
* Familiar with other enterprise systems such as DeltaV, MES, and SAP
* Strong leadership, organizational, communication, technical and writing skills

Responsibilities:

* Improve the technical capabilities and quality practices within the department
* Coordinate activities and resolve issues across the department, other groups, and/or projects
* Ensure response to and/or resolve recurring technical or processing issues
* Drive safety, quality and accountability culture
* Communicate information effectively through updates, reports, and summaries
* Lead improvements in processes and methods that reinforce cGMP within the department and/or across the site
* Participate directly in internal, external, and global health authority audits/inspections
* Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems
* Guide investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills
* Establish goals of the department
* When appropriate, assist in providing leadership on project teams
* Provide routine updates on progress, status, and issues associated with campaigns/projects
* Provide support and/or direction to junior staff when necessary
* Exercise sound judgment when making decisions
* Make critical decisions in collaboration with key stakeholders
* Demonstrate accountability for personal, departmental, and organizational initiatives

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers

The base pay range for this position at commencement of employment is expected to be $92800 to $152425 ; 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.

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