Drug Product Manufacturing Associate I - Formulations 2nd Shift

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 30,000 - 33,000; Full time

Benefits offered by this job

Health insurance (dental & vision)

401(k) plan

Paid time off

Flexible spending account

Job summary

PCI Pharma Services is seeking a Drug Product Manufacturing Associate I - Formulations to support routine production in a GMP environment. You will work with the Drug Product team to execute sterile formulation tasks and in-process testing, ensuring compliance with SOPs and regulatory requirements.

The role covers equipment operation, documentation of batch records, and collaboration across production planners and quality teams. It is a 2nd shift position with competitive benefits.

Qualifications

• High School Diploma required.
• Bachelor’s degree in life sciences preferred.
• 0-2 years of relevant experience in manufacturing or a lab environment.
• Detail oriented with strong written and verbal communication.
• Ability to work independently or as part of a team.
• Familiarity with cGMP and manufacturing data entry.

Responsibilities

• Performs manufacturing tasks including sterile filtration, formulation, in-process testing, and preparation of components.
• Supports implementation of procedures and production schedules.
• Assists personnel with technical issues arising during shift.
• Updates Master Batch Records and SOPs as needed.
• Maintains production resources and aids product development.
• Operates equipment such as TFF, Rotavap, and CIP systems.
• Maintains cGMP compliance in clean rooms A–D.
• Documents batch records accurately and timely.
• Coordinates sterilization material prep for autoclave or ovens.
• Collaborates with engineers on troubleshooting.
• Handles lab waste per SHE procedures.
• Maintains production environment and interacts with clients/vendors as needed.
• Works with Production Planner on QAD work orders and materials.
• Expects regular full-time attendance.

Skills

Detail oriented

Verbal and written communication

Ability to work independently

Team collaboration

Education

High School Diploma

Bachelor’s degree in life sciences

Tools

Microsoft Office

Job description

Summary

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Drug Product Manufacturing Associate I - Formulations is responsible for the implementation of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Associate I will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Associate I will develop a strong understanding of both the technical aspects of the role as well as the quality systems that govern cGMP manufacturing.

Shift

2nd Hours: 2:00PM-10:30 PM

Responsibilities

• Performs various manufacturing tasks, including sterile filtration, formulation, in-process testing, preparation of formulation components, and product development projects, in accordance with established Standard Operations Procedures (SOPs) and cGMP regulations.
• Supports the implementation of manufacturing procedures and production schedules.
• Effectively assists other personnel with technical issues and problems that may arise during the shift.
• Initiates revisions to current Master Batch Records, SOPs, and department desktop aids.
• Supports the maintenance of group production resources and assists with product development projects.
• Expected to operate production equipment, including the TFF system, Rotavap, Microfluidizer, Homogenizer, chiller, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven, and CIP system.
• Maintains qualification to execute aseptic operations in GMP production facilities comprised of Grade A, B, C, and D manufacturing clean room areas.
• Supports routine maintenance and troubleshooting of production equipment.
• Accurately documents, completes, and reviews batch records, as needed.
• Coordinates and leads preparation of materials and components for sterilization in autoclave or dehydrogenation oven.
• Collaborates with other technical personnel on troubleshooting and engineering activities.
• Collects and disposes of lab waste according to established Safety, Health, and Environment (SHE) procedures.
• Maintains cGMP environment according to the production needs of the Drug Product group.
• May be required to interact and collaborate with clients and third-party vendors.
• Works closely with Production Planner to manage QAD work orders and ensure production materials are obtained according to the manufacturing schedule.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].

Qualifications

• High School Diploma required.
• Bachelor’s degree in a life sciences discipline or equivalent preferred.
• Minimum of zero to two (0-2) years of relevant experience in a manufacturing or laboratory environment.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
• Familiarity with cGMP, manufacturing, machine operations, and data entry.
• Must be familiar with Microsoft Office applications.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Salary & Benefits

• The hiring rate for this position is $21.69 - 24.41 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.
• PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

Equal Employment Opportunity Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity– at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.