Production Process Specialist - Temporary

Production Process Specialist - Temporary

PolyPeptide is seeking a Manufacturing Process Specialist to provide technical support for peptide manufacturing processes from technology transfer through commercial production. This role is ideal for someone who enjoys being close to the manufacturing floor, solving technical process challenges, and helping ensure processes are robust, compliant, and consistently executed.

As a Manufacturing Process Specialist, you will support SPPS, cleavage, purification, and lyophilization operations while partnering with Manufacturing, Process Development, Quality Control, Quality Assurance, and external stakeholders. You will play an important role in technology transfer, equipment qualification, process validation, PPQ, CPV, investigations, and continuous improvement.

Your work will directly support PolyPeptide's commitment to quality, compliance, operational excellence, and reliable delivery to customers.

What you will do:

• Provide floor-side technical support during peptide manufacturing operations, including SPPS, cleavage, purification, and lyophilization
• Investigate and troubleshoot critical manufacturing issues
• Contribute technical expertise to deviation investigations, root cause analysis, and CAPA implementation
• Lead or support technology transfers between Process Development and Manufacturing, as well as across manufacturing sites
• Ensure transferred processes are well understood, reproducible, and supported by complete documentation
• Support Process Performance Qualification, PPQ, activities, including protocol drafting, execution support, data collection, data review, and reporting
• Support Continued Process Verification, CPV, through process monitoring, trend analysis, and identification of potential process variability
• Introduce and qualify new manufacturing equipment
• Draft and execute IQ, OQ, and PQ protocols and prepare associated GMP documentation
• Standardize and improve manufacturing workflows and batch documentation
• Help reduce human error, improve data integrity, and increase operational consistency
• Collaborate cross-functionally with Manufacturing, Process Development, Quality Control, and Quality Assurance
• Support routine operations, investigations, and new production introductions
• Serve as a technical subject matter expert for process-related topics with clients, regulatory teams, and internal stakeholders

What you bring:

• Bachelor's degree in Chemistry, Biochemistry, Engineering, or a related field
• Minimum of 3 years of experience in pharmaceutical manufacturing or a cGMP environment
• Peptide manufacturing experience preferred
• Strong understanding of cGMP manufacturing principles
• Technical knowledge of SPPS, cleavage, purification, and lyophilization preferred
• Working knowledge of equipment qualification, including IQ, OQ, and PQ
• Hands-on experience supporting process validation activities, including PPQ execution and CPV
• Familiarity with cleaning validation principles, residue risk assessment, and contamination control
• Experience authoring or reviewing GMP documentation
• Strong understanding of quality systems, including deviations, investigations, CAPAs, and change controls

What makes you successful in this role:

You are a hands-on technical problem solver who can work effectively on the manufacturing floor and communicate clearly with cross-functional teams. You are comfortable reviewing data, identifying trends, investigating issues, and translating technical concepts for different audiences.

You bring a structured, data-driven approach to root cause analysis and process improvement. You understand how to balance process robustness, compliance, and operational efficiency in a regulated manufacturing environment.

Key competencies:

• Process troubleshooting and technical problem solving
• Root cause analysis and data-driven decision making
• cGMP manufacturing knowledge
• Technology transfer support
• Process validation and equipment qualification
• PPQ and CPV support
• GMP documentation accuracy
• Cross-functional collaboration
• Clear verbal and written communication
• Client-facing and audit communication confidence
• Proactive, floor-focused technical support

Work environment and physical demands:

This role is primarily office-based, with intermittent work in the GMP manufacturing environment to provide floor-side technical support. Office-based work includes computer-based documentation, data review, and technical coordination. Manufacturing floor support requires appropriate gowning and PPE.

Physical demands may include:

• Prolonged sitting and/or standing
• Movement between work areas when supporting GMP manufacturing activities
• Occasional lifting of up to 25 pounds
• Use of hands for data entry, equipment operation, or laboratory tasks
• Exposure to chemicals, equipment noise, or temperature-controlled environments in lab or production settings
• Occasional evening, weekend, or overtime hours to support production or testing deadlines
• Reasonable accommodations will be made as needed.

Why join PolyPeptide:

At PolyPeptide, you will be part of a quality-driven organization supporting important pharmaceutical and peptide-based programs. As a Manufacturing Process Specialist, your technical expertise will help ensure manufacturing processes are reliable, scalable, compliant, and ready to meet customer needs.

If you are looking for a role where you can combine technical process knowledge, floor-side manufacturing support, validation, investigations, and continuous improvement, we encourage you to apply.

Salary: $28-$32 per hour

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.