Scientist I - Process Development

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JOB SUMMARY

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

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

• •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

• •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), SmartSheets, LabX, and Empower

QUALITIES

• •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

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

• •Works directly with Process Development personnel
• •Works closely with QCAD, VAL, MTS, and Operations
• •Will interact with Customers on a regular basis

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

Required to lead and train junior level Process Development Scientists positions.

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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.