Process Manager, Upstream Process Development

Rentschler Biopharma Inc.; Milford (CT); On-site; USD 120,000 - 145,000; Full time

Job summary

Rentschler Biopharma Inc. is seeking a senior process expert to advance upstream development at our Milford site. You will design experiments, apply QbD for PPQ campaigns, and collaborate with MSAT and manufacturing to ensure smooth tech transfers.

Strong bioreactor and DoE expertise are essential. Ideal candidates bring 10+ years in biotech process development, solid data-analysis skills, and a track record of cross-functional leadership, enabling delivery of high-quality documentation for

Qualifications

• University degree with 10+ years related experience or graduate degrees with commensurate experience.
• Expertise in bioreactor operation, scale-up/scale-down, DoE, and CMC dossier sections.
• Strong communication, planning and cross-functional collaboration skills.
• Ability to work independently and in global teams with client interfaces.

Responsibilities

• Develop clinical and commercial upstream processes including harvest.
• Design experiments to optimize, characterize, or scale processes.
• Apply QbD principles for PPQ campaigns and CAPA-based improvements.
• Collaborate with MSAT, other departments, and clients; prepare technical data and reports.
• Transfer programs to manufacturing and author necessary documents.

Skills

Bioreactor operation

Scale-up/scale-down

DoE

CMC dossier knowledge

Statistical data analysis

Cross-functional collaboration

MS Office proficiency

Education

University degree + 10+ years

Master’s degree + 7+ years

PhD + 5+ years

Tools

MS Office

Job description

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.

Duties and Responsibilities

• Develop clinical and commercial processes for Upstream unit operations including harvest
• Design and evaluate experiments to develop, optimize, characterize, or scale-up/ scale down processes
• Employ QbD principles when using univariate and multivariate studies in preparation for PPQ campaigns
• Align and harmonize methods and approaches with international colleagues
• Lead, train, and mentor junior lab staff
• Identify and evaluate new and existing technologies for more efficient processing, improved control, and increased process knowledge
• Contribute to process science ways-of-working and infrastructure improvements
• Transfer programs to manufacturing.
• Provide process descriptions and gap analysis
• Collaborate with MSAT on change controls
• Support Manufacturing and MSAT as the process Subject Matter Expert
• Support Manufacturing and Quality with deviation closures and appropriate CAPAs
• Interface with clients.
• Analyze, prepare, and formally present data
• Collaborate on client approved documents
• Provide technical consulting as a Subject Matter Expert
• Author documents
• Experimental protocols, technical reports, risk assessments, gap assessments, SOPs, facility fit assessments
• Process Subject Matter Expert review on batch records CMC dossier sections for IND/ IMPD and BLA/ MMA

Qualifications

• Years of experience and education (one of the following):
  • A university degree and 10+ years of related experience
  • A Master’s degree and 7+ years
  • A PhD and 5+ years of experience
• Expertise in bioreactor operation, scale-up/ scale-down principles, the use of statistical tools for data analysis and DoE, CMC dossier sections relating to process definitions, and working effectively with other departments
• The candidate must demonstrate critical thinking, be self-motivated, accountable, inquisitive, and have excellent organization and communication skills, and demonstrates the ability to work both independently and as a member of local and global teams
• Excellent customer service skills and ability to meet client project deadlines
• Flexibility of hours to support process development or MFG floor activities over weekends and holidays. Weekend and holiday hours are compensated per company policies
• Flexibility to switch between projects
• Advanced ability with Microsoft Office (Word, Excel, and PowerPoint)

Preferred Qualifications

• Late-stage development and process characterization
• AMBR and single-use vessels
• Clarification (Harvest) unit operations and principles
• Process Qualification/ Process Validation (PPQ)
• QbD principles
• Continued Process verification (CPV)
• Regulatory requirements
• Experience with audits

Working Conditions

• Laboratory and manufacturing clean-room environments working with chemical reagents and processing equipment
• Compliance with Personal Protective Equipment, clean room gowning, and EH&S requirements
• Normal office working conditions: computer, phone, files, printer, etc
• Interaction with people in the lab, other departments, and clients
• Fast-pace environment with job completion deadlines

Physical Requirements

• Lifting up to 25 lbs
• Standing/walking in lab environment for extended periods
• Sitting in office environment for extended periods for computer-based work

Base Pay Range

$120,000 - $145,000

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.