Scientist II - Process Development

Job description

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 DUTIES Lead Process Development projects, serving as the technical lead and SME for formulation and process design activities. Supports more complex Process Development projects as a collaborator, working with a senior scientist to achieve project milestones Execute and analyze experiments to achieve project milestones with minimal supervision. Develop and implement phase-appropriate process development strategies aligned with program objectives and regulatory expectations. Act as a Process Development representative on internal and client-facing project calls, providing technical updates and strategic input. Demonstrate proficiency in formulation design, sterile filtration, lyophilization, and post-processing for both small molecules and biologics. Develop and optimize processes for high-potency compounds, including antibody-drug conjugates (ADCs) and other complex modalities. Support technology transfer activities and assist in scale-up or manufacturing transitions. Perform in-process and finished product testing within the Process Development laboratory, such as HPLC/UPLC, UV-Vis spectroscopy, Flowcam, Karl Fischer titration, DSC/FDM, and other related assays to confirm acceptance criteria. Troubleshoot analytical or process challenges and propose scientifically sound corrective actions. Responsible for proper maintenance, calibration, and cleanliness of laboratory instruments and equipment. Perform or assist in routine facilities cleaning and equipment upkeep as required. Author and review Process Development batch records, protocols, and reports to ensure technical accuracy and compliance with quality standards and client demand. Review executed documentation for accuracy and completeness prior to submission to management. Draft and maintain Standard Operating Procedures (SOPs) and related controlled documents for Process Development operations. Provide training, technical guidance, and mentorship to junior scientists and laboratory staff. 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 exemplary 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. Experience with lyophilization cycle design preferred. Works independently with little direction; demonstrates a proven track record of leading tasks to completion. Ability to learn new technologies and concepts and drive implementation in the laboratory 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 Advanced Degree in (PhD) in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 0-3 years’ experience in pharmaceutical development or CDMO industry. BS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 5+ years’ experience in pharmaceutical development or CDMO industry A strong foundation in clinical-phase development and analytical characterization of drug products, including biologics and other complex modalities In depth knowledge of biopharmaceutical and/or medical product regulation, formulation, filtration, filling, and lyophilization operations 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. #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, 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.