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

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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.