Process Development Scientist

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.

Key Responsibilities:

• 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.

Qualifications:

Education & Experience

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

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: $90k-$120k 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.