Associate Director, Quality Control (Cell Factory) *PC 440

Your Tasks: 

The role leads the Cell Factory Quality Control (CF-QC) functions at Miltenyi Bio Industry Gaithersburg and interacts with internal product development and quality/quality control groups, with customers for clinical and commercial products and with Miltenyi's network of service providers and suppliers. The role is responsible to oversee the transition from development to implementation of GMP analytical methods for in-process and lot release/stability testing of products. The role interacts with authorities and acts as first-line contact for CF-QC matters for internal stakeholders.

The role will be part of the Global QC Leadership Team and herein ensures information sharing, seeks for alignment and actively supports global process streamlining/harmonization activities preliminary for CF-QC departments across Miltenyi departments. The role will manage and embed a quality first culture within CF-QC, set and drives the long-term strategy and near-term objectives in the CF-QC in collaboration and alignment with other QC-CF`s across Miltenyi sites, The roles assure governance with the Quality Management System (QMS), ensures compliance to all applicable regulatory standards, and fosters engagement in a highly competent team.

Essential Duties and Responsibilities:

• Provide leadership in line management and matrix, fosters personal development and professional growth for CF-QC employees in-line with business needs, promote and support exchange of employees across Miltenyi sites where applicable.
• Drive strategic decisions and leadership on product quality, general and cell factory specific Quality Control systems and implement appropriate processes in support of these.
• Manage, prioritize and oversee all CF-QC related activities such as method implementation, method transfer and validation, sampling plans, stability studies, comparability studies, specification setting, reference standard implementation, lot release testing. 
• Support manufacturing investigations and ensure appropriate communication to customers and stakeholders.
• Develop, monitor, foster continuous improvement of key (CF-) quality control initiatives and metrics within the Gaithersburg Bio Industry teams and Global Quality Control. Ensure appropriate Quality metrics are deployed effectively throughout the CF-QC and where it applies to drive improvement.

Requirements: 

• M.S. or Ph.D. degree in Biologics, Chemistry, Biochemistry, Analytical Chemistry, or a related field; 10+ years’ industry experience in analytical development and/or quality control in a pharmaceutical/ Biotech industry within a GMP regulated environment, including experience in a leadership role; Or a combination of experience and education.
• Mid-level experience in product characterization, method development, validation, and transfer of non-compendial and compendial analytical methods for biologics using various techniques such as automated assay systems and PCR as well as biophysical characterization methods.
• Extensive knowledge of cGMP regulations and guidelines and strong knowledge of FDA, ISO, EMA, and ICH requirements applicable to biologics and cell therapies.
• Demonstrated experience in leadership (“hands-on” leader with expertise in growing and developing teams).
• Comfortable in a fast-paced environment with minimal direction and able to prioritize and adjust workload based upon changing priorities.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.
• Excellent written and verbal communication skills.
• Highly organized and able to dynamically re/prioritize efforts.
• Adept change agent by proactively soliciting input to garner broad sustainable support.
• Creatively navigates and converges business and compliance objectives.
• Foster a culture of collaboration, open communication, and continual improvement. 

 Physical Demands:

 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific