Affinity Chromatography, Biochemistry, Chemical Engineering, Chromatographic Systems, Chromatography, Commissioning, Communication Skills, Continuous Improvement, Cross-Functional, GMP (Good Manufacturing Practices), Identify Issues, Manufacturing, Manufacturing Equipment, Manufacturing Systems, Mentoring, Process Development, Process Engineering, Process Improvement, Process Manufacturing, Process Validation, Regulations, Regulatory Requirements, Startup, Support Documentation, System Start-Up, Team Player, Technical Leadership, Technical Writing, Validation Plan, Validation Testing, Writing Skills
Job Title: Senior Process Engineer Downstream (Biologics & Peptides)
Location: Boulder, CO (100% Onsite)
Duration: 6 Months + Extensions
Start Date: ASAP
Job Summary
We are seeking a Senior Process Engineer with strong expertise in downstream processing to support the development, scale-up, and commercialization of biologics and peptide-based therapeutics. This role will focus on designing, optimizing, and implementing purification processes and manufacturing systems within a GMP-regulated environment.
The ideal candidate will have hands-on experience with chromatography and tangential flow filtration (TFF) technologies, along with a proven track record supporting process scale-up, equipment qualification, and manufacturing startup activities.
Key Responsibilities
- Lead downstream process development and optimization activities for biologics and peptide products
- Design, specify, and support implementation of purification systems including chromatography and TFF skids
- Support process scale-up from development through pilot and commercial manufacturing
- Drive startup, commissioning, qualification, and troubleshooting of downstream manufacturing equipment
- Develop and execute process validation and verification strategies aligned with GMP and regulatory requirements
- Collaborate with MSAT, Upstream, Manufacturing, and Quality teams to ensure process robustness and consistency
- Author and review technical documentation including process descriptions, validation protocols, and regulatory support documents
- Serve as a technical SME for downstream purification operations and technologies
- Mentor junior engineers and support continuous improvement initiatives
Required Qualifications
- Bachelor s, Master s, or PhD in Chemical Engineering, Biochemical Engineering, or related field
- 8+ years of experience in biopharmaceutical process engineering with strong downstream processing expertise
- Hands-on experience with:
- Chromatography systems (affinity, ion exchange, HIC, etc.)
- Tangential Flow Filtration (TFF) systems
- Experience supporting equipment startup, commissioning, and qualification activities
- Strong understanding of process validation and GMP manufacturing environments
- Experience supporting or leading tech transfer and process scale-up activities
- Strong troubleshooting, communication, and cross-functional collaboration skills
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Stark Pharma Solutions Inc