We are seeking a proactive, strategic, and hands-on DSP Process Manager. They will demonstrate flexibility, adaptability, and can effectively work in a fast paced, rapidly changing CDMO environment. They are self-motivated, accountable, inquisitive, and have excellent organizational and communication skills. They can multi-task while delivering excellent customer service.

The Process Manager in the Downstream Process Development group is a functional project(s) lead, who independently designs, executes, and support biologics downstream purification processes including technology transfer activities both from the client(s) and internally to the GMP manufacturing facility.

Duties and Responsibilities

• Develop scale-able and robust downstream processes for clinical and commercial GMP manufacturing.
  • Design experiments related to development, optimization, scale-up of all steps of various recombinant protein formats (e.g., antibodies, bispecific and enzymes) inclusive of viral clearance studies.
  • Lead lab team members in the execution of experiments.
  • Apply DoE and other advanced statistical techniques to design and evaluate late-stage development activities and process characterization studies in preparation for process qualification and validation at manufacturing scale.
  • Define the control strategy for commercial manufacturing.
• Interface with clients.
  • Analyze, prepare, and formally present data.
  • Author and collaborate on client-approved documents.
  • Provide technical consulting as a Subject Matter Expert.
• Transfer programs to Manufacturing.
  • Provide process descriptions and gap analyses.
  • Collaborate with MSAT on change controls, deviations, and investigations.
  • Support Manufacturing and MSAT as process Subject Matter Expert, including on floor support.
• Author high-quality documents.
  • Experimental protocols, technical reports, risk/gap assessments, SOPs, and facility fit assessments.
  • Assist with and review relevant chapters of CMC dossier sections for IND/IMPD and BLA/MAA.
  • Process and Subject Matter Expert review on batch records.
• Lead, train, and mentor junior lab staff.
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
  • Contribute to the overall operations of process sciences lab and infrastructure improvements.
• Active contributor/connector on harmonization and alliance of concepts, procedures, techniques, and documentation within international sites of the company
• Serve as Process Science representative and participate in cross functional meetings.

Qualifications

• Years of experience and education (one of the following):
• A university degree and 5-8+ years of related experience
• A Master's degree and 3-5+ years
• A PhD and 1-3+ years of experience
• Expertise in chromatographic processes, filtration techniques, protein chemistry, and associated analytical methods
• Expertise in scale-up/scale-down principles as well as the use of statistical tools for data analysis and DoE
• Experience in process characterization, qualification/validation (PPQ) and/or continued process verification (CPV) is preferred
• Experience in viral clearance validation and scale down validation is preferred
• Advanced proficiency with required software - Unicorn, JMP/MODDE, Word, Excel, PowerPoint
• The candidate must demonstrate critical thinking, be self-motivated, accountable, inquisitive, 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
• Basic knowledge of project management
• 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

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-paced environment with job completion deadlines

Physical Requirements

• Frequent lifting up to 10 lbs
• Sitting for extended periods for computer-based work
• Standing/walking to work in lab environment for extended periods

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.