Director Site Quality Control *PC 1600

Miltenyi Biotec; Gaithersburg (MD); On-site; USD 193,000 - 227,000; Full time

Benefits offered by this job

Health/vision/dental insurance

401(k) plan

Bonus eligibility

Job summary

Miltenyi Biotec in Gaithersburg, MD, seeks a dynamic leader to head Quality Control at the site level. You will drive GMP QC strategy, governance of the QMS, and ensure compliance with FDA/EMA/ICH.

You will lead a high-performing team, collaborate with product development, manufacturing, QA, and external providers to deliver robust QC for biologics and cell therapies. You will be part of the Global QC Leadership Team, shaping long-term goals, implementing continuous improvement, and promoting a

Qualifications

• Bachelor's degree in Biologics, Chemistry, Biochemistry, Analytical Chemistry, or related field; 10+ years in analytical development and/or quality in GMP.
• Experience in analytical method validation and transfer for biologics.
• Strong knowledge of cGMP regulations and FDA/ISO/EMA/ICH requirements.
• Proven leadership and change-management experience.
• Excellent communication and organizational skills.

Responsibilities

• Provide leadership in line management and matrix, fostering development for site QC staff.
• Drive strategic decisions on product quality and QC systems and implement processes.
• Oversee all site QC activities: method implementation, transfer, validation, sampling plans, stability studies, comparability studies, specs.
• Support manufacturing investigations and communicate with customers and stakeholders.
• Develop and monitor continuous improvement of QC initiatives and metrics.

Skills

GMP QC leadership

Analytical development

Regulatory compliance

Data integrity

People management

Method validation

Method transfer

Quality metrics

Cross-functional collaboration

Education

Bachelor's degree in Biologics/ Chemistry/ Biochemistry

Tools

Flow cytometry

PCR

HPLC

Job description

Your Role:

The role will lead all Quality Control functions at the site level and interact with internal product development, manufacturing, quality assurance and with Miltenyi's network of providers and suppliers to develop and implement GMP quality control of biological products.

The role will manage and embed a quality first culture, set and driving the long-term strategy and near-term objectives in the areas of quality control, assure governance with the Quality Management System (QMS), ensure compliance to all applicable regulatory standards, and foster engagement in a highly competent team.

The role will be part of the Global QC Leadership Team and herein ensures information sharing, seeks alignment and actively supports global process streamlining/harmonization activities preliminary for QC departments across sites.

Essential Duties and Responsibilities:

• Provide leadership in line management and matrix, fosters personal development and professional growth for site QC employees in-line with business needs, promotes and supports exchange of employees across Miltenyi sites where applicable.
• Drive strategic decisions and leadership on product quality, Quality Control systems and implement appropriate processes in support of these.
• Manage, prioritize and oversee all site 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 quality control initiatives and metrics within the Gaithersburg Bioindustry teams and Global Quality Control. Ensure appropriate Quality metrics are deployed effectively throughout the QC and where it applies to drive improvement.

Requirements:

• Bachelor’s 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.
• Experience in product characterization, analytical method validation, and transfer of analytical methods for testing biologics (preferred flow cytometry, PCR methodologies, HPLC)
• 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) and organizational change management
• 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 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

Salary and Benefits:

The anticipated base salary range has been established at $192,952 - $226,954/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.

Diversity and Inclusion:

Miltenyi Biotec, Inc., is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Background Checks:

Miltenyi Biotec, Inc. participates in E-Verify.

Accommodations:

The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.

About Miltenyi Biotec, Inc.:

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies – transformative methods that mobilize the body’s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.