Intern, GMP Production

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

Job Duties:

• Maintain a clean working environment and contribute to the overall lab cleanliness.
• Perform daily miscellaneous tasks (daily balance check, storage chamber check, pipette calibration, magnehelic gauge recording, etc.)
• Perform and document miscellaneous equipment cleaning as per Standard Operating Procedures.
• Assist in GMP Production by preparing buffers, collecting analytical HPLC samples, in-process rinse of glasswares, and to properly dispose of hazardous waste.
• Assist in the lyophilization process of peptides.
• Request for raw materials as per Standard Operating Procedures.
• Execute GMP Work Area Preparation.
• Assist in inventory of solvents and reagents.
• Able to follow instructions per Batch Production Records and using the correct materials/chemicals.
• Assist in GMP Production by dissolving amino acids, performing in process checks, refilling solvents, and proper operation of fume hoods when working with chemicals.

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

• Efficient - good time management; able to execute and complete multiple tasks.
• Communication skills: able to understand and follow verbal instructions. Able to consistently update supervisors regarding progression of tasks.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed.
• Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is frequently required to reach with hands and arms and may regularly lift and/or move up to 35 pounds.

Requirements

• Ability to work effectively and efficiently as part of a team within a fast paced environment.
• High School diploma or equivalent required.
• Motivated self-starter
• Work effectively with diverse departmental groups
• Capable of basic math skills

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities