Formulation Technician III M-F 3PM to 11:30 PM

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 Formulation Technician III mentors others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety Guidelines of PCI. With general supervision, the technician performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding activities for biopharma and medical device products. The incumbent must possess the ability to address non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with Master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors.

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 safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action
• Trains and mentors both peers and less experienced staff in the performance of proper formulation techniques
• Has ownership for the daily formulation activities to ensure all scheduled tasks/events are completed
• Is responsible for 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 of errors that could lead to product and or finical loss
• Troubleshoots and resolve problems with equipment or processes in the course of performing job duties
• Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
• Prepares equipment and components for sterilization and Lyophilization
• Operates processing equipment including autoclaves, depyrogenation ovens, vial washers, homogenizers, and others
• Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs
• Collaborates with Supervisor and MTS during drafting of new manufacturing batch records and protocols.
• Completes Batch Records accurately and completely prior to submission to supervision for review
• Complies with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
• Initiate and support revisions to SOPs and FORMs as needed
• Participates in investigations, and contribute to identifying corrective and preventative actions
• Cross trains to increase technical skills across the department
• Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements
• As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed
• Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients
• 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)

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc.

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 education, AS degree or BS degree in related field of study is preferred

• Experience and knowledge of formulation/compounding tools and equipment
• Minimum 4 years formulation/compounding work experience in a GMP environment, preferably in fill finish pharmaceutical operations
• 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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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.