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 IV leads 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 leads and 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. Addresses 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, reviews and revises master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors.

• 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
• Maintains weekly/daily schedule up to date and provides direction to the team
• Works with management to provide a positive culture within operations
• Has ownership for the daily formulation activities to ensure scheduled 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 or errors that could lead to product and or finical loss
• Initiates the production of batch documentation used for engineering and cGMP production
• Prepares and updates Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation updates
• Completes executed 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
• Authors process deviations when these occur within the department, participates in investigations, and contributes to identifying corrective and preventative actions
• Cross trains to increase technical skills across the department
• Trains others on the team, and ensures proper training completion within the team prior to assigning tasks
• 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, perform other manufacturing tasks for example filling, capping etc., as needed.
• Works with enabling groups to improve/implement processes.
• Other duties as assigned.

• High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred

EXPERIENCE -

• Experience and knowledge of formulation/compounding tools and equipment
• Minimum 3 year's work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations
• Leadership experience as a team lead or supervisor type role preferred
• Demonstrated ability to prioritize multiple projects and activities

PROFESSIONAL SKILLS

• Strong interpersonal skills
• Strong working knowledge of MS Office suite is preferable

QUALITIES -

• Attention to detail and positive attitude are key attributes
• Able to follow rules and regulations perfectly
• Detail oriented with strong mechanical aptitude
• Strong interpersonal skills to resolve and de-escalate issues
• Honesty, integrity, respect and courtesy with leadership and peers
• Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services
• Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment

• 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)

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

TRAVEL - < 10%

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Join us and be part of building the bridge between life changing therapies and patients.

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.