Scientist I - Process Development

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.
• 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.
• 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
• Able to prioritize multiple ongoing projects and activities to meet customer and company timelines
• 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

• MS/PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 0-5 years’ experience in pharmaceutical development or CDMO industry.
• BS in relevant degree with 5+ years’ experience.
• 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 QC, AD, 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.
• Join us and be part of building the bridge between life changing therapies and patients.
• Let’s talk future

EQUAL EMPLOYMENT OPPORTUNITY (EEO)

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.