Production Chemist II- 3rd Shift

Job Summary:

The Chemist II plays a critical role in the manufacturing of Active Pharmaceutical Ingredients (APIs) in a cGMP-regulated environment. Building upon foundational experience, this role involves executing complex synthesis processes, troubleshooting production challenges, mentoring junior staff, and supporting continuous improvement efforts. The Chemist II contributes directly to PolyPeptide’s mission of delivering high-quality products on time and in full compliance with regulatory standards

Key Responsibilities:

General:

1. Under occasional or necessary supervision and direction: ensure proper execution of the BPR (batch production record).
   
   
2. Ensures proper GxP process are carried out as per SOP or BPR
   
   
3. Reports any problems or issues regarding equipment used in processing to supervision
   
   
4. Is responsible for maintaining high safety, housekeeping and cleanliness standards. Including but not limited to proper PPE use and enforcement, 5s adherence, etc.
   
   
5. Ensures proper material usage and inventory management through ERP system.
   
   
6. Ensures proper ordering of raw materials necessary for processing.
   
   
7. Ensures proper return of all materials not used during processing.
   
   
8. Performs daily review of BPR and ERP to ensure AlCOA+ is followed.
   
   
9. Communicates effectively between departments (I.E. QA, Maint, QC, SC, etc.)
   
   
10. If required, training of new operators; act as a resource for Chemist I
    
    
11. Make Basic “Go-No Go” decisions with supervisor and/or senior chemist
    
    
12. Assist Production scientist with BPR revision/update
    
    
13. Initiates and ensures completion in timely manner of deviations/CAPAs in quality system
    
    
14. Initiate PCC/ECR/and other quality documents when required for processing
    
    
15. Assist in generating data and updates to scientist for customer TCs.
    
    
16. Ensures compliance with Site KPI goals
    
    
17. Performs any and all additional duties as required for this position.
    
18. Identify and resolve process deviations, equipment malfunctions, or material inconsistencies in a timely manner.
    
19. Mentor and train junior chemists (Chemist I) and new team members on processes, safety protocols, and compliance standards.
    
20. Work closely with Quality Assurance (QA), Engineering, and R&D teams to ensure smooth transitions during tech transfers, scale-ups, and troubleshooting efforts.
    
21. Assist in implementing corrective and preventive actions based on audit findings.

Upstream:

1. Checks reactor system for proper operation in accordance with SOP and/or operation manual.
   
   
2. During processing, monitors chemical reactions (IPC tests, Ninhydrin, HPLC analysis, etc) and under occasional or necessary direction of supervision, chemist personnel responds with appropriate actions to ensure proper processing.
   
   
3. Using established procedures (safety and process) and under occasional or necessary supervision, performs intermediate chemical processing steps.
   
   
4. Performs drying processes in accordance with established processes and procedures.
   
   
5. Performs analytical IPCs where necessary.

Downstream:

1. Prepares buffers/solutions for purification processes.
   
   
2. Under occasional or necessary supervision, purifies crude peptide by using HPLC’s.
   
   
3. Conducts lyophilization process according to established guidelines.
   
   
4. Performs in-process checking of the fractions by using analytical HPLC and reports results to supervision and/or Sr. Production Chemist personnel.

Qualifications:

Education & Experience

• Required Education: Bachelor’s degree in science degree or equivalent.

• Experience: Minimum 3 years of relevant experience, peptide manufacturing experience preferred.

Skills & Competencies

• Technical Skills: Advanced knowledge of chromatography techniques HPLC for analyzing and purifying compounds. Skilled in identifying and improving bottlenecks in production processes to enhance efficiency and quality.
• Soft Skills: Clearly communicates with team members and cross-functional departments, works effectively in a team-oriented production environment, prioritizes tasks to meet production deadlines without sacrificing quality, takes responsibility for own work and adheres to compliance requirements, always prioritizes personal and team safety.
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