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 QC leadership team in Milford, the Director, Quality Control Technical Services will manage and oversee a Quality Control team responsible for maintaining GxP systems and processes that support site business objectives; within QC this will be from Clinical Development to Clinical Supply and/or Commercial manufacture at a Contract Development & Manufacturing Organization (CDMO). The candidate will work in close collaboration with Manufacturing, Supply Operations, Process Sciences and Quality Assurance to support continual improvement and cGMP compliance. The Director will work functionally as well as part of a multi-disciplinary team to support the development and approval of our clinical development programs, commercial operations, and implement strategic imperatives within a fast-paced environment.
Duties and Responsibilities
- Will manage teams of professionals within Quality Control encompassing raw materials testing, microbiology, QC LIMS master data and electronic systems, analytical equipment lifecycle management, documentation and data integrity
- Hire and develop employees within the department through coaching and mentorship while setting clear expectations for success
- Leads and manages the Milford Site QC Leadership team meetings and follow up action plans
- Establish and maintain Quality Control systems and processes at Milford, MA site
- Develops and maintains department budgets (expense and capital) in alignment with overall organizational goals for profitability
- Acts as portfolio manager for QC project work including scheduling, prioritizing and resource planning to ensure client contract deliverables are met
- Represents QC at the project team level and interacts with Rentschler clients as needed
- Ensure timely execution of client projects and clear communications to clients
- Identify and initiate improvements to Quality Control Systems and Standard Operating Procedures (SOPs), ensuring compliance with all relevant quality standards and regulatory requirements
- Verify & establish department readiness for audits by both internal and external authorities, serve as primary Quality Control contact for regulatory inspections and client audits
- Analyze regulatory authorities’ programs, guidance documents and activities in areas relevant to testing biological products
- 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
- Collect and report quality control metrics via Quality Management Reviews and the Quality Council
- Promotes a strong Quality Culture based on the Rentschler core values
Qualifications and Key Characteristics
- BS required, MS preferred in a scientific/technical discipline with 15+ years of experience in a QC position within the biological and/or CDMO industry
- 10+ years in a management/leadership role(s)
- PhD in a scientific/technical discipline a plus
- Experience in microbiological methods and contamination control
- Subject matter experiment in laboratory equipment qualification and data management
- Ability to apply GMP regulations and international guidelines to all aspects of the position
- Experience with regulatory inspections and client audits specifically within a startup/early phase and commercial QC laboratories
- Extensive experience with writing and managing investigations and risk assessments
- Proficient in MS Office application suite as well GMP electronic applications such as LIMS
- Outstanding leadership abilities with demonstrated analytical and critical thinking skills while managing high performing teams
- Proven leader, delegator, and decision maker with the ability to interact with all levels
- Executive presence with strong interpersonal and communication skills, verbal and written
Working Conditions
- Manufacturing environment with potential chemical, electrical and physical hazards
- Personal protective equipment must be worn in the laboratories according to Rentschler safety requirements
- Exposure to cool/hot storage conditions
- May be working in a loud area at times, that requires hearing protection and other protective equipment to be worn
- Working around chemicals such as solvents, acids, bases and reactive or flammable materials
- May require immunization before performing work within the manufacturing area
- Pace may be fast and job completion demands may be high
- Some international travel (no more than 5% time)
Physical Requirements
- May be required to stand for long periods of time while performing physical duties
- May be required to lift up to 10 lbs
- Must be able to work safely with materials and equipment
- PPE as required
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Base Pay Range
$180,000 - $220,000
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.
