Manager, Quality Control - Analytical Development

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 key member of QC team, the QC- Analytical Development Manager will be responsible for providing leadership, management, and oversight to QC Development functions such as owning the analytical method lifecycle (qualification, validation, transfer activities), QC Projects, and
Investigations. This position will provide support site and ensure test methods are in a compliant state.

Duties and Responsibilities

• Oversees and manages the activities involved with development, transfer, qualification, and validation of analytical test methods for existing product line and potential additions.
• Guide development of transfer protocols and reports.
• Responsible for design, development, execution, statistical analysis of validation protocols for analytical, bioanalytical, and compendial methods used for the analysis of product and process impurities.
• Provides technical expertise for method optimization, verification, qualification and validation. This includes analyzing and interpreting data, writing protocols and reports, investigating analytical problems and developing approaches to rectify those problems.
• Preparation and oversight of methods, protocols, trend reports and summaries for cGMP testing as required in support of tech transfer activities.
• Interact with contract, corporate, and regulatory agency representatives, and auditors. Regularly present to and interact with senior management to set and modify goals, budget and operations related to the functional area.
• Perform regular technical presentations to senior management; participate in departmental senior staff meetings and decisions.
• Review current laboratory practices to identify alternative strategies or cost saving measures for laboratory improvement.
• Provides scientific review and approval of protocols, reports, study design and standard operating procedures.
• Performs managerial duties, as assigned, in support of QC operations such as resource management and failure investigation review.
• Project planning of analytical work packages (method developments, qualifications, validations, specification development, sampling plans)
• Investigate, troubleshoot, and resolve test method related deviations and CAPA’s, as well as provide SME support as needed.
• Demonstrated strong organizational and technical writing skills.

Qualifications

• Bachelor’s degree in Analytical Chemistry, Biochemistry, Microbiology or closely related scientific discipline with 8+ years of relevant experience; Masters or PhD
• Prior supervisory experience is preferred
• Must possess skills and knowledge of general immunological, bioanalytical, and chemical test methods such as ELISA, qPCR, IEF, Cell-based assays, gel electrophoresis, Western Blot, DNA sequencing, HPLC with multiple modes of detection, capillary gel electrophoresis, and UV spectroscopy
• Advanced knowledge of cGMPs, safety and data integrity
• Experience in executing phase appropriate method qualifications and validations
• Experience in assay method validation, equipment validation, and analytical investigation for biotherapeutic products
• Ability to apply statistical analysis to QC monitoring and trending
• Ability to partner and influence across a matrixed environment
• Excellent communication skills; verbal and written
• Able to work in a fast-paced environment and adapt based on business needs
• Must be a team player and be able to mentor and develop others

Working Conditions

• Laboratory environment working with chemical reagents and analytical equipment
• Normal office working conditions: computer, phone, files, fax, copier.
• Personal Protective Equipment must be worn as required
• Minimum travel required.

Physical Requirements

• Frequent lifting up to 10 lbs.; frequent standing/walking.
• Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods.
• PPE as required

____________________________________________________________________________
Base Pay Range
$130,000 - $160,000
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.