Job Summary:

The Production Chemist III plays a key role in leading the manufacturing of Active Pharmaceutical Ingredients (APIs) in a cGMP-regulated environment. This position requires advanced knowledge of chemical processes, problem-solving, and leadership skills. The Production Chemist III ensures high-quality production, operational efficiency, and compliance with industry standards, while also driving continuous improvement initiatives. As a senior member of the team, you will also be responsible for mentoring junior chemists and leading process optimization efforts to support PolyPeptide’s commitment to exceptional quality and on-time delivery.

Key Responsibilities:

General:

1. Under minimal 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. Anticipates and reports any problems or issues regarding equipment used in processing to supervision
   
   
4. Assist supervisors with scheduling and forecast needs beyond the immediate project.
   
   
5. Interprets test results and takes appropriate action when required to ensure proper and acceptable processing.
   
   
6. Is responsible for maintaining high safety, housekeeping and cleanliness standards. Including but not limited to proper PPE use and enforcement, 5s adherence, etc.
   
   
7. Ensures proper material usage and inventory management through ERP system.
   
   
8. Ensures proper ordering of raw materials necessary for processing.
   
   
9. Ensures proper return of all materials not used during processing.
   
   
10. Performs daily review of BPR and ERP to ensure AlCOA+ is followed.
    
    
11. Self sufficient with communications between departments (I.E. QA, Maint, QC, SC, etc.)
    
    
12. Act as SME for process: performs training and mentoring of new operators
    
    
13. Make general “Go-No Go” decisions with supervisor and/or quality
    
    
14. Assist Production scientist with BPR revision/update
    
    
15. Initiates and ensures completion in timely manner of deviations/CAPAs in quality system
    
    
16. Initiate and ensures closure of PCC/ECR/and other quality documents when required for processing
    
    
17. Assist in generating data and updates to scientist for customer TCs.
    
    
18. Assist in investigations resulting from processing deviations
    
    
19. Ensures compliance with Site KPI goals
    
    
20. Performs any and all additional duties as required for this position.
    
21. Provide mentorship and training to junior chemists (Chemist I & II), sharing technical knowledge and fostering their growth within the team. Lead by example in adhering to safety, quality, and compliance standards.
    
22. Ensure strict adherence to safety protocols when handling hazardous chemicals and reagents. Promote a safety-first culture and conduct regular safety training sessions for the team.

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 minimal direction of supervision, chemist personnel responds with appropriate actions to ensure proper processing.
   
   
3. Using established procedures (safety and process) and under minimal 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 minimal 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 of 5 years relevant experience in manufacturing or a regulated environment; peptide manufacturing experience preferred.

Skills & Competencies

List the key skills and competencies needed to succeed in the role. Separate technical skills from soft skills.

• 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. Advanced troubleshooting of chemical and mechanical processes during production, identifying root causes of issues and implementing corrective actions quickly. Skilled in operating advanced production equipment, including reactors, centrifuges, vacuum pumps, rotary evaporators, and other large-scale manufacturing systems.

• 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.

Work Environment & Physical Demands:

• Physical Requirements: This position requires the employee to regularly stand, walk, sit and talk or hear. The employee must also be capable of writing, using a computer keyboard. The ability to lift up to 25 lbs..
• Work Environment: Work with hazardous materials and chemicals. Ability to wear a respirator and other PPE as required for specific tasks.

• Performance Metrics (KPIs):

• Maintain ≥ 95% on-time production completion for scheduled batches with minimal deviations.
• 100% adherence to documentation protocols (e.g., batch records, SOPs, and logbooks) with no significant deviations or documentation errors.
• Improve team performance by mentoring colleagues to achieve ≥ 90% of their key performance indicators (KPIs).

Salary: $37-$48/hr

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.