Job Summary:

The Production Chemist I is responsible for manufacturing Active Pharmaceutical Ingredients (APIs) in a cGMP-regulated environment. This role plays a critical part in supporting PolyPeptide’s mission to deliver high-quality pharmaceutical products on time to our customers. The ideal candidate is detail-oriented, safety-conscious, and committed to maintaining compliance with industry regulations.

Key Responsibilities:

General:

1. Under general supervision and direction: ensure proper execution of the BPR (batch production record).
   
   
2. Ensures proper GxP processes are carried out as per SOP or BPR
   
   
3. Reports any problems or issues regarding equipment used in processing to supervision and/or senior Production Chemist personnel.
   
   
4. Reports any nonconformities discovered to supervision and/or senior Production Chemist
   
   
5. Is responsible for maintaining high safety, housekeeping and cleanliness standards. Including but not limited to proper PPE use and enforcement, 5s adherence, etc.
   
   
6. Ensures proper material usage and inventory management through ERP system.
   
   
7. Performs daily review of BPR and ERP to ensure AlCOA+ is followed.
   
   
8. Communicates effectively between departments (I.E. QA, Maint, QC, SC, etc.)
   
   
9. Ensures compliance with Site KPI goals
   
   
10. Performs any and all additional duties as required for this position.
    
11. Be able to work in the team
    
12. Ability to work independently and manage one’s time

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 general direction of supervision and/or senior Production Chemist personnel responds with appropriate actions to ensure proper processing.
   
   
3. Using established procedures (safety and process) and under general 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 general 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. High School Diploma with 3 years of GMP manufacturing experience in peptides and oligonucleotides.
• Experience: 0-2 years of relevant experience, peptide manufacturing experience preferred.

Skills & Competencies

• Technical Skills: Sample preparation, using fume hoods and biosafety cabinets, safe handing of hazardous chemicals and reagents
• 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):

• Demonstrate full compliance by completing all assigned training within the first 6 months, positioning yourself for independent operation in the production environment.
• Maintain continuous adherence to cGMP requirements, contributing to zero operator-related findings during audits and inspections.
• Identify and drive at least one meaningful process improvement project per year, resulting in measurable benefits such as time savings, reduced waste, or improved yield.

Salary: $28-$33/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.