Process Manager (m/w/d) Process Science DSP

Process Manager (m/w/d) Process Science DSP

Apply locations Laupheim, Germany time type Full time posted on Posted 11 Days Ago job requisition id JR2027

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1,400 employees from 25 nationalities. What unites us at Rentschler Biopharma is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

As part of our group Process Science DSP, we are seeking a Process Manager. The Process Manager will be in charge of the upstream/downstream processes of our customers’ APIs throughout the complete product lifecycle. This comprises the following key responsibilities:

Tasks and responsibilities

• Design and development of scalable downstream processes from bench to commercial scale for a wide range of biopharmaceuticals.
• Transfer of customer downstream processes to the Rentschler process format.
• Design of late stage process optimization and process characterization / robustness studies by risk-based strategies in preparation of process validation at manufacturing scale.

These responsibilities will be assumed by actively carrying out and managing the following tasks:

• Direct communication and representation towards our customers in “face-to-face meetings”, conference calls, etc.
• Consulting our customers in subject matter-specific project strategy within the product lifecycle.
• Ensure compliance with international technological and regulatory standards.
• Responsible for compliance of timelines and milestones according to overall project plans.
• Technical supervision of lab technicians and engineers in DSP development.
• Scientific advice for manufacturing science and technology team (scale up to internal and external production sites, deviations, changes, process validation).
• Subject matter expert in an interdisciplinary and cross-functional team with colleagues from production, USP, quality control, QA/RA, and Innovation.
• Compile and review protocols and reports in a timely manner.
• Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA).
• Participate in customer audits and authority inspections.
• Participate in innovation and internal projects for driving progress of the group/company.

What is important to us

• PhD or relevant experience in biotechnology, biochemistry or comparable scientific/technical field.
• Several years of active experience in the field of DSP development preferably using scalable technologies in context of industrial pharmaceutical manufacturing.
• Deep knowledge and understanding of chromatographic processes, filtration techniques, protein chemistry, and analytical methods.
• Knowledge of typical biopharmaceutical lifecycles and regulatory guidelines as well as experience in the topics of Quality-by-Design (QbD), process control strategies, Critical Quality Attributes (CQA), and Critical Process Parameters (CPP) are beneficial.
• Deep knowledge and experience with Design-of-Experiments (DoE), statistical modelling, and corresponding software (JMP).
• Application-oriented basics in statistics (TOST test, p-value, trend & outlier analysis, etc).
• Basic knowledge in upstream processing.
• Basic knowledge in project management.
• High level of initiative and excellent organizing ability.
• Entrepreneurial mindset, economic and analytical thinking.
• Strong and collaborative communication skills, team spirit, flexibility, and outcome-oriented working.
• Fluency in German and English.

What we offer

• Work in a company that offers real value and manufactures medicines for critically ill patients.
• Contagious joy in the job as well as a collegial working environment.
• Access to exclusive, personalised training through the Rentschler Academy.
• 30 days of holiday.
• Flexible working hours, flexitime account, and mobile working.
• Responsibility, initiative, further development.
• Team and company events.
• Company health management and pension scheme.
• Various employee discounts.
• Company child-care centre.
• Future-proof industry.
• Indefinite contract.