Sr Director, Quality Control - Analytics & Product Testing

Advancing medicine to save lives. Together. 

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.  

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.  

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. 

As a member of the Rentschler Biopharma Quality Control leadership team in Milford, the Sr Director Quality Control - Analytics & Product Testing will primarily be responsible for leading a Quality Control team responsible for analytical method qualification/validation, testing incoming samples (including process intermediates, drug substance and/or drug product), and providing timely results that support GxP manufacturing and product disposition. The QC Analytics & Product Testing team is composed of analytical leaders, scientists and QC analysts that cover 7-day per week testing. This role will collaborate with Quality Control Technical Services and Quality Operations Support & Stability staff to periodically evaluate processes to ensure that QC activities are efficient, timely in terms of delivery of client contract deliverables, and safeguard data integrity. The successful candidate will need to be flexible and agile with the ability to pivot quickly to changing circumstances and business needs.

Duties and Responsibilities

• Lead QC Analytics & Product Testing team and laboratory activities
• Hire and develop employees within the department, while setting clear expectations for success
• Provide active feedback, coaching and employee development
• Act as Portfolio manager for QC project work including scheduling, prioritizing and resource planning to ensure client contract deliverables are met
• Oversee analytical method transfer and method validation activities – requiring in-depth understanding of protein chemistry and analytical chemistry methodologies (incl. peptide mapping, glycan analysis, SEC-HPLC, IEX-HPLC, potency analysis by chromogenic assay)
• Participate in Milford Site Quality Leadership team meetings and follow up action plans
• Collaborate within QC to support authoring, review and/or approval of QC related documents ensuring all appropriate documents are generated and retrievable per GMP standards in support of regulatory submissions and inspections
• Support the team in managing OOS/OOT investigations, deviations and change controls, and implementing appropriate CAPA as it relates to QC
• Provides representation in customer and authority audits and implementation of resulting corrective measures
• Responsible for supporting operational aspects of the QC Analytics laboratory, including data verification, PO management, records management, etc.
• Drives continuous improvement initiatives to enhance productivity and efficiency within QC
• Collect and report quality control metrics via Quality Management Reviews and the Quality Council
• Consistently advise site and Quality management of potential and actual actions that could adversely affect the business; represent quality exposures or represent opportunities to be pursued
• Promotes a strong Quality Culture based on the Rentschler core values

Qualifications

• A bachelor's or master's degree in chemistry, biochemistry or a related life science field with substantial hands-on experience in Quality Control related activities
• 18+ years of industry experience in a GMP QC environment, with a minimum of 8+ years of managerial and project management experience
• Leadership skills to manage technical and laboratory personnel 
• Strong sense of accountability, self-motivation, and drive in meeting project objectives
• Direct experience in managing and overseeing QC related activities internally and at third party vendors
• Understanding of FDA/EU/ICH regulations and guidance related to critical quality attributes, release testing, analytical validation and transfer, and stability testing
• Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities ensuring effective time management
• Excellent facilitation and project management skills, with strong verbal and written communication skills
• Ability to effectively communicate across all levels and cross-functional teams
• Ability to work independently as well as collaboratively in a team environment

Working Conditions

• Normal office working conditions: computer, phone, files, fax, copier

• Personal Protective Equipment must be worn as required

• Minimum travel required

• Will interact with other people

• Pace may be fast and job completion demands may be high

Working Conditions

• PPE as required
  

____________________________________________________________________________ Base Pay Range

$210,000 - $260,000

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.