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.
Skills Required
- PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field, with 0–3 years of pharmaceutical development or CDMO experience
- Alternatively, BS or MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field, with 5+ years of pharmaceutical development or CDMO experience
- Strong laboratory and wet chemistry skills
- Knowledge of cGMP, regulatory guidelines, aseptic manufacturing, bulk intermediates, and medical device manufacturing
- Foundation in clinical-phase development and analytical characterization of drug products, including biologics and complex modalities
- Knowledge of biopharmaceutical and medical product regulation, formulation, filtration, filling, and lyophilization operations
- Experience with HPLC/UPLC, UV-Vis spectroscopy, FlowCam, Karl Fischer titration, DSC/FDM, and related assays
- Experience with Microsoft Office, SmartSheets, LabX, and Empower
- Experience with lyophilization cycle design
- Ability to work independently, lead tasks, prioritize multiple projects, and communicate effectively with clients and internal teams
- Ability to wear PPE, gown into controlled manufacturing areas, lift or move equipment requiring 25–50 pounds of force, stand for prolonged periods, and work extended hours
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
