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.
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