JOB SUMMARY:

The Development Scientist is responsible for designing, executing, and optimizing synthetic processes for peptide and/or oligonucleotide API development. This role supports the transition of laboratory processes into scalable, cGMP-compliant manufacturing operations. The Development Scientist plays a key role in cross-functional project teams and contributes technical expertise to ensure robust, efficient, and cost-effective processes. This role contributes directly to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers.

EDUCATION & EXPERIENCE

• Required Education:
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• Ph.D. in chemistry or chemical engineering with 1 year relevant experience or Masters with 5 years of relevant experience

• Experience:
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• 4 years of industry experience in with a focus on organic chemistry and preferably peptide chemistry/ downstream purification.

Skills & Competencies

• Technical Skills:

• • Strong knowledge of synthetic organic chemistry, process development, and analytical techniques.
• Experience with scale-up and tech transfer into manufacturing environments is a plus.
• Familiarity with cGMP requirements and regulatory expectations for clinical and commercial manufacturing.
• Soft Skills:
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• Excellent analytical thinking, problem-solving, and communication skills.

• Ability to work independently and in collaborative, multidisciplinary teams.
• Competencies:
• Process Development and Scale-Up Expertise
• Analytical and Problem-Solving Skills
• Technical Proficiency in Organic and Peptide Chemistry
• Cross-Functional Collaboration and Tech Transfer
• GMP and Regulatory Compliance

• Plans and coordinates Technology Transfer from Development to Production on-site and across-sites
• Using established procedures (safety and process) and under minimal supervision, performs intermediate chemical processing steps.
• Checks reactor system for proper operation in accordance with SOP and/or operation manual.
• During processing, monitors chemical reactions (color and completeness of chemical reactions) and under minimal direction of supervision responds with appropriate actions to ensure proper processing.
• Prepares solutions for purification.
• Interprets test results and takes appropriate action when required to ensure proper and acceptable processing.
• Under minimal supervision, purifies crude peptide by using HPLC’s.
• Conducts lyophilization process according to established guidelines.
• Performs drying processes in accordance with established processes and procedures.
• Performs in-process checking of the fractions by using analytical HPLC and reports results to supervision and/or Sr. Development Chemist personnel.
• Reports any significant and unresolvable problems or issues regarding equipment used in processing to supervision. May perform general machine/equipment troubleshooting.
• Is responsible for maintaining high safety, housekeeping and cleanliness standards.
• Conducts and observes daily development activity and reports any deviations to supervision.
• Performs any and all additional duties as required for this position.