Process Development Senior Scientist

Job Summary:

The Senior Development Scientist is responsible for designing, developing, and optimizing synthetic processes for peptides and/or oligonucleotides to support both clinical and commercial manufacturing. This role plays a key part in the technical execution of development projects, leading experimental design, process scale-up, and transfer activities while working closely with cross-functional teams to ensure regulatory and quality standards are met. This role contributes directly to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers.

Key Responsibilities:

1. Lead the design and development of robust, scalable synthetic routes for peptides and/or oligonucleotides.
2. Plan and execute laboratory studies for process optimization, scale-up, and technology transfer to GMP manufacturing.
3. Develop and evaluate purification and isolation strategies including HPLC, preparative chromatography, and lyophilization techniques.
4. Interpret analytical data and collaborate with Quality Control and Analytical Development teams to support characterization and release testing.
5. Draft and review technical reports, batch records, development protocols, and regulatory documentation.
6. Mentor junior scientists and provide technical leadership within the Development group.
7. Identify and troubleshoot issues in synthesis, purification, or scale-up processes.
8. Contribute to continuous improvement initiatives and innovation in synthetic methodologies.
9. Participate in cross-functional meetings with Project Management, Manufacturing, QA, and Regulatory teams to align on project goals and timelines.
10. Support customer audits and regulatory inspections as a subject matter expert.

Qualifications:

Education & Experience

Required Education:

• Ph.D. in Organic Chemistry, Biochemistry, Chemical Engineering, or a related field; or Master’s degree in the same fields with equivalent industry experience.

Experience

• Minimum 3 years of relevant industry experience with a Ph.D.
• Minimum 6 years of relevant industry experience with a Master’s degree
• Experience in peptide or oligonucleotide synthesis, process development, scale-up, and technology transfer
• Familiarity with GMP manufacturing and regulatory requirements for clinical and commercial API production

Skills & Competencies

Technical Skills:

• Proven experience in peptide or oligonucleotide synthesis, process development, and scale-up.
• Strong knowledge of solid-phase and/or solution-phase synthesis techniques.
• Familiarity with GMP manufacturing and regulatory expectations for clinical and commercial API production.
• Hands-on experience with analytical tools such as HPLC, LC-MS, NMR, and UV-Vis

Soft Skills:

• Excellent problem-solving, documentation, and communication skills.
• Ability to manage multiple priorities in a fast-paced, collaborative environment.

Competencies:

• Analytical Thinking & Problem Solving
• Technical Leadership & Mentorship
• Collaboration & Cross-Functional Communication
• Initiative & Innovation
• Attention to Detail & Documentation Rigor

Work Environment & Physical Demands:

This role may be based in an office, laboratory, or GMP manufacturing environment, depending on the position. Office-based employees primarily work at a computer in a standard office setting, while lab and manufacturing roles may require work in controlled environments with appropriate gowning and PPE.

Physical demands may include:

• Prolonged sitting or standing, depending on the role.
• Frequent movement between work areas and occasional lifting of up to 25 pounds.
• Performing repetitive tasks, including pipetting, weighing, and data entry.
• Use of hands for data entry, equipment operation, or laboratory tasks.
• Exposure to chemicals, equipment noise, or temperature-controlled environments in lab or production settings.
• Occasional evening, weekend, or overtime hours to meet production or testing deadlines.
• Reasonable accommodations will be made as needed.

Salary: $120k-$135k per year

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.