Senior Director (QC)

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 currently 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 300 employees is expanding Just's innovative platform and footprint - Opening our first North American J.POD® commercial manufacturing facility in the Seattle area and building our second European J.POD commercial manufacturing facility in the Toulouse France are.

SENIOR DIRECTOR QUALITY CONTROL

Just-Evotec Biologics is seeking a highly motivated Sr. Director to join a fast-paced, collaborative, and multidisciplinary team to lead all aspects of Quality Control for the advancement of low-cost biotherapeutics manufacturing. The primary focus of this job is to lead and guide the Quality Control functions supporting Just-Evotec’s Biologics Manufacturing state of the art J.POD Facility, located in Redmond, WA. This highly qualified candidate will partner with Quality Assurance, Manufacturing Operations, Technical Operations, Materials Management, F&E, Process Development and EH&S functions to ensure GMP and regulatory compliance.

The position requires strong management and leadership skills as well as a deep understanding of biologics analytical GMP testing of clinical and commercial drug substance and drug product biological products, GMP raw materials inspection and release, and facility environmental monitoring programs. A proven track record of technical skills in these areas, as well as experience leading groups of QC scientists is required. Strong written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are necessary. The successful candidate will also proactively provide collaborative support to the internal stakeholders and have excellent customer-service orientation with a high degree of professionalism.

Educational Requirements:

• PhD degree in relative scientific discipline with 15+ years of industry experience; MS or BS degree with extensive industry experience.

Responsibilities:

• Provide direction for analytical, microbial, and sample management groups to ensure timely testing.

• Develop method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development or to QC as well as the transfer and validation of methods between manufacturing sites.

• Ensure success of Quality Control functions through strategic and day-to-day leadership.

• Develop and maintain strategic plan, including outsourced activities and business continuity, to ensure cGMP testing needs are met.

• Responsible for QC audit and inspection readiness, including support and preparation of responses to observations and ensuring response CAPAs are effective.

• Identify gaps, design collaborative solutions and provide guidance for laboratory efficiencies and improvements.

• Planning, coordination, and continuous improvement of methods, processes, and systems to assure the quality of testing.

• Provide input and change management for quality improvements affecting QC methods and processes.

• Development and implementation of testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and strategy documents that support the Quality Management System.

• Establish clear expectations, develop metrics and key performance indicators to monitor performance and ongoing activities; includes meeting and exceeding internal stakeholder and customer expectations.

• Hire, build and maintain expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities as required.

• Provide technical expertise during laboratory investigations such as CAPA, OOS and OOT.

• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved.

Requirements:

• Minimum of 15 years of experience in the pharmaceutical industry with experience leading a Quality Control function, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with at least 5 years in a GMP QC release testing role.

• Oversee hiring; provide coaching, guidance, and career development for highly motivated and very competent QC team.

• Thorough understanding of phase appropriate global cGMP regulations for release and stability testing of biological products.

• Regulatory inspection and commercial product launch experience.

• The candidate should have the ability to work with limited direction to follow through with specific tasks.

• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance biological manufacturing and release/stability testing.

• Extensive knowledge of GdPs, GMPs and DS / DP multi-compendial assays (USP, EP, JP).

• Extensive understanding of biologics manufacturing processes.

• Excellent technical writing, collaboration and verbal communication skills.

• Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).

• Proficiency with Microsoft Office applications (Word, Excel and PowerPoint).

Preferred Qualifications:

• Entrepreneurial drive to achieve business objectives.

• Knowledge and expertise to solve complex technical problems.

• Active participation/lead technical projects with collaborators and vendors.

• Experience with Waters Empower CDS, HPLC, UPLC and Beckman PA800 CE systems.

• Experience with ELISA based impurity or potency methods.

The base pay range for this position at commencement of employment is expected to be $150,000 to $210,000; 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.