Formulation Technician II, Sun to Wed 6:30 AM to 5PM
Bedford, New Hampshire, United States · On-site
Mid level
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…
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…
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…
Skills: GMP Compliance, Labeling, Packaging, Batch Record Documentation, Regulatory Compliance
Supervisor, Drug Product Manufacturing - 2nd Shift
San Diego, California, United States · On-site
$85k–$96k/yr
Senior
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…
Skills: Drug Product Manufacturing, cGMP Compliance, Fill-Finish Equipment, Batch Record Authoring, Strategic Planning
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…
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…
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…
Skills: Project Management, Device Design, Process Optimization, Risk Mitigation, MS Project
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…
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…
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…
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…
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…
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…
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…
Drug Product Manufacturing Technician I/II/II M-F 4PM to 12:30 AM
Madison, Wisconsin, United States · On-site
Entry level
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…
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…
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…
Skills: Executive Support, Calendar Management, Travel Coordination, Microsoft PowerPoint, Microsoft Excel
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…
Director, Technical Solutions Development and Manufacturing (Oral Solid Dose / Sterile Fill Finish)
Bedford, New Hampshire, United States · On-site
Senior+
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…
Skills: Technical Sales, Proposal Development, Sterile Fill Finish, Oral Solid Dose, Business Development
Senior Director, Sustainable Procurement and Process Excellence
Philadelphia, Pennsylvania, United States · On-site
Senior+
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…
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Full-time
high school, associate degree, bachelor degree
Posted 29d ago
~35 hrs/week
Responsibilities
Responsible for daily formulation activities, including lab setup, API dissolution, and maintaining batch integrity to ensure scheduled tasks are completed. Provides troubleshooting expertise for internal and external manufacturing processes and maintains critical production documentation.
Requirements
Requires a high school diploma or GED, with a STEM degree preferred and 1-3 years of experience in a GMP environment. Candidates must be able to lift 30lbs, stand for long periods, and adhere strictly to safety and regulatory guidelines.
Full job description
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.
This position will have the primary responsibility for daily formulation activities to ensure scheduled activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Maintains and adheres to safe work habits and all applicable PCI PHARMA SERVICES safety procedures and guidelines
Has ownership for the daily formulation activities to ensure all scheduled tasks/events are completed
Performs critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss with minimum to no supervision.
Initiate the production of batch documentation used for engineering and cGMP production.
Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes
Completes Batch Records accurately and completely prior to submission to supervision for review
Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
Initiate quality system events when these occur within the department
Cross train in the Fill department to increase technical skills including but not limited to Fill/Cap in room 148
Able to complete prep work, including operation of autoclave and depyrogenation oven
Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements.
Complete gowning qualification to perform aseptic operations in the manufacturing area
Work with enabling groups to improve/implement processes.
Other duties as assigned.
Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
Able to stand for long periods of time, the majority of the work shift
Able to lift 30lbs repeatedly
Able to wear PPE (mask, gloves, respiratory)
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
High school Diploma, GED, or equivalent credential required; AS degree or BS degree in a STEM field (Science, Technology, Engineering, or Mathematics), such as Computer Science, Engineering, Mathematics, Physics, or a related discipline is preferred.
•Minimum 1-3 year’s work experience in a GMP environment preferably in fill finish pharmaceutical operations; equivalent combination of education and experience will be considered.
Experience and knowledge of formulation/compounding tools and equipment
Demonstrated ability to prioritize multiple projects and activities
Strong interpersonal skills
Strong working knowledge of MS Office suite is preferable
Strong communication skills
Attention to detail and positive attitude are key attributes
Able to follow rules and regulations perfectly
Resilient as well as flexible
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) 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.
We are PCI Pharma Services. CDMO.
Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow.
We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
Clinical Trial ManufacturingPackagingStorageand Global DistributionAnalytical Development and TestingCommercial PackagingQP ServicesFormulation Development and Drug ManufacturingSterile Fill-FinishLyophilization Manufacturing Services
We are PCI Pharma Services. CDMO.
Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow.
We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
Clinical Trial ManufacturingPackagingStorageand Global DistributionAnalytical Development and TestingCommercial PackagingQP ServicesFormulation Development and Drug ManufacturingSterile Fill-FinishLyophilization Manufacturing Services