Production Process Chemist - 21189

Job Description

Job Description

Production Process Chemist - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a Production Process Chemist in San Diego, CA who possesses:

• Bachelor's degree in Chemistry, Biochemistry, or a related science field
• Strong organizational skills and attention to detail
• cGMP, peptide manufacturing, or batch support experience is a plus

FULL DESCRIPTION: We are seeking a Production Process Chemist to support peptide manufacturing processes from technology transfer through commercial production. This 3-month temporary role will provide floor-side technical support, assist with investigations and troubleshooting, support equipment qualification, and contribute to process documentation, PPQ, and CPV activities. The ideal candidate will have a science background, strong organizational skills, and an interest in learning manufacturing processes, cGMP documentation, and batch support within a peptide manufacturing environment.

The selected candidate will be responsible for:

• Providing floor-side technical support during peptide manufacturing operations, including SPPS, cleavage, purification, and lyophilization
• Assisting with investigations and troubleshooting of critical manufacturing issues
• Collecting data and performing technical assessments
• Supporting deviation investigations, root cause analysis, and CAPA implementation
• Supporting technology transfers between Process Development and Manufacturing, as well as across manufacturing sites
• Helping ensure strong process understanding, reproducibility, and complete GMP documentation during transfer and production activities
• Assisting with Process Performance Qualification activities, including protocol execution support, data collection, data review, and reporting
• Supporting Continued Process Verification through process monitoring, trend analysis, and identification of potential process variability
• Supporting qualification of new manufacturing equipment, including IQ, OQ, and PQ protocol execution
• Preparing and maintaining related GMP documentation
• Helping improve manufacturing workflows and batch documentation to reduce human error, strengthen data integrity, and improve operational consistency
• Collaborating cross-functionally with Manufacturing, Process Development, Quality Control, and Quality Assurance
• Supporting routine operations, investigations, and new production introductions
• Learning and supporting peptide manufacturing processes, paperwork, and batch-related documentation as needed

The selected candidate will also possess:

• Bachelor's degree in Chemistry, Biochemistry, or a related field required
• Minimum of 1 year of experience in pharmaceutical manufacturing or a cGMP environment preferred
• Peptide manufacturing experience preferred
• Foundational understanding of cGMP manufacturing principles
• Familiarity with peptide manufacturing processes, including SPPS, cleavage, purification, and lyophilization preferred
• Familiarity with equipment qualification, including IQ, OQ, and PQ preferred
• Hands-on exposure to process validation activities, including PPQ execution and CPV support, preferred
• Understanding of cleaning validation principles, residue risk assessment, and contamination control preferred
• Familiarity with quality systems, including deviations, investigations, CAPAs, and change controls
• Strong verbal and written communication skills
• Ability to communicate technical information clearly to operators, peers, and cross-functional partners
• Hands-on, proactive mindset with willingness to work directly on the manufacturing floor
• Developing problem-solving and troubleshooting skills
• Ability to collaborate effectively across Manufacturing, Process Development, Quality Control, and Quality Assurance
• Strong attention to detail and commitment to compliance, data integrity, and operational excellence
• Ability to balance process robustness, compliance, and manufacturing efficiency
• Ability to work onsite in San Diego, CA
• Ability to work a temporary 3-month assignment
• Ability to work Monday through Friday, 8:00 AM to 5:00 PM or 7:30 AM to 4:30 PM

Physical Requirements:

• Ability to sit, stand, and walk throughout the workday, including time on the manufacturing floor
• Ability to use hands and fingers for documentation, computer work, data entry, and handling materials or equipment as needed
• Ability to review batch records, GMP documentation, technical data, reports, and computer screens for extended periods
• Ability to communicate by phone, email, video meeting, and in person throughout the workday
• Ability to occasionally bend, reach, lift, carry, or move standard laboratory, manufacturing, or office materials as needed
• Ability to work in a cGMP manufacturing environment while following applicable safety, gowning, documentation, and quality procedures
• Ability to wear required personal protective equipment as needed for manufacturing or production floor support

Salary Range: $28 to $30/hour

More information can be found at

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.

Company Description

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.