Scientist - Process Development

Position: Scientist I - Process Development
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.
** _JOB SUMMARY
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* ** The Scientist I position supports the efforts of the Process Development department within a fast-paced, expanding CDMO. This job will require extensive laboratory work, testing, and strategic client support of pharmaceutical development projects.*
* ** _JOB DUTIES
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* ** Support Process Development projects, serving as a SME and collaborator for formulation and process design activities.*
* ** Support senior scientists in performing experiments to achieve project milestones.*
* ** Act as a Process Development representative on internal and client-facing project calls, providing technical updates and strategic input.*
* ** Support the formulation design, sterile filtration, lyophilization, and post-processing for both small molecules and biologics, including antibody-drug conjugates (ADCs) and other complex modalities.*
* ** Support technology transfer activities and assist in scale-up or manufacturing transitions.*
* ** Executor of in-process and finished product testing within the Process Development laboratory, utilizing methods such as HPLC/UPLC, UV-Vis spectroscopy, Flowcam, Karl Fischer titration, DSC/FDM, and other related assays to confirm acceptance criteria.*
* ** Ensure proper maintenance, calibration, and cleanliness of laboratory instruments and equipment.*
* ** Perform or assist in routine facilities cleaning and equipment upkeep as required.*
* ** Draft and review Process Development batch records, protocols, and reports to ensure technical accuracy and compliance with internal quality standards.*
* ** Draft and maintain Standard Operating Procedures (SOPs) and related controlled documents for Process Development operations.*
* ** Collaborate cross-functionally with internal stakeholders including Quality Control (QC), Manufacturing Technical Services (MTS), and Operations, as well as external client teams, to ensure alignment and successful project execution.*
* ** _PROFESSIONAL SKILLS
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* ** Requires proficient laboratory and wet chemistry skills*
* ** Knowledge of current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing, as well as bulk intermediate and medical device manufacturing.*
* ** Works independently with little direction; demonstrates a proven track record of leading tasks to completion.*
* ** Must consistently exhibit positive, effective interpersonal skills with internal and external teams, including relationship management of clients.*
* ** Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines*
* ** Demonstrates excellent oral and written communication skills and can provide detailed project updates (PowerPoint) to clients and other internal departments efficiently and concisely.*
* ** Requires excellent organizational and interpersonal skills, team-player*
* ** _EDUCATION/EXPERIENCE
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* ** BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 0-5 years' experience in pharmaceutical development or CDMO industry*
* ** A desire to work in clinical-phase development and analytical characterization of drug products, including biologics*
* ** Experience with MS Office (Word/Excel/Teams/PowerPoint/SharePoint), Smart Sheets, LabX, and Empower*
* ** _QUALITIES
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* ** Detail oriented and a results driven team player*
* ** Ability to work in a dynamic, fast paced work environment*
* ** Honesty, integrity, respect and courtesy with all colleagues*
* ** Creative with the ability to work with minimal supervision and balanced with independent thinking*
* ** Resilient through operational and organizational change*
* ** _PHYSICAL REQUIREMENTS
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* ** Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.*
* ** Ability to gown and gain entry to controlled manufacturing areas.*
* ** Ability to lift, pull or push equipment requiring up to 25-50 lbs of force*
* ** Ability to stand for prolong periods in a production suite and work extended hours.*
* ** _COMMUNICATIONS & CONTACTS
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* ** Works directly with Process Development personnel*
* ** Works closely with QCAD, VAL, MTS, and Operations*
* ** Will interact with Customers on a regular basis** + _TRAVEL
-_ < 10%
** _MANAGERIAL &

SUPERVISORY RESPONSIBILITIES
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* ** Required to lead and train junior level Process Development Scientists positions.*
* ** LI-AK2
** 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,…