{"id":1929478,"url":"https://alion.io/job/pci-scientist-ii-process-development","title":"Scientist II - Process Development","company":{"id":1987116,"name":"PCI Pharma Services","domain":"pci.com","url":"https://alion.io/company/pci-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":20,"ghost_share":0,"stale_share":0.85,"repost_share":0,"time_to_fill_p50_days":30,"computed_at":"2026-10-26T05:57:25Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":52000,"max_usd":108000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":638},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Microsoft Office","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-09-23T00:00:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-10-26T04:15:10Z","board_verified":true,"closed_at":null,"days_open":33,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":33},"description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\nWe are PCI.\nOur 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.\nJOB DUTIES\nLead Process Development projects, serving as the technical lead and SME for formulation and process design activities.\nSupports more complex Process Development projects as a collaborator, working with a senior scientist to achieve project milestones\nExecute and analyze experiments to achieve project milestones with minimal supervision.\nDevelop and implement phase-appropriate process development strategies aligned with program objectives and regulatory expectations.\nAct as a Process Development representative on internal and client-facing project calls, providing technical updates and strategic input.\nDemonstrate proficiency in formulation design, sterile filtration, lyophilization, and post-processing for both small molecules and biologics.\nDevelop and optimize processes for high-potency compounds, including antibody-drug conjugates (ADCs) and other complex modalities.\nSupport technology transfer activities and assist in scale-up or manufacturing transitions.\nPerform 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.\nTroubleshoot analytical or process challenges and propose scientifically sound corrective actions.\nResponsible for proper maintenance, calibration, and cleanliness of laboratory instruments and equipment.\nPerform or assist in routine facilities cleaning and equipment upkeep as required.\nAuthor and review Process Development batch records, protocols, and reports to ensure technical accuracy and compliance with quality standards and client demand.\nReview executed documentation for accuracy and completeness prior to submission to management.\nDraft and maintain Standard Operating Procedures (SOPs) and related controlled documents for Process Development operations.\nProvide training, technical guidance, and mentorship to junior scientists and laboratory staff.\nCollaborate 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.\n\nPROFESSIONAL SKILLS\nRequires exemplary laboratory and wet chemistry skills\nKnowledge 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.\nWorks independently with little direction; demonstrates a proven track record of leading tasks to completion.\nAbility to learn new technologies and concepts and drive implementation in the laboratory\nMust consistently exhibit positive, effective interpersonal skills with internal and external teams, including relationship management of clients.\nAbility to prioritize multiple ongoing projects and activities to meet customer and company timelines\nDemonstrates excellent oral and written communication skills, and can provide detailed project updates (PowerPoint) to clients and other internal departments efficiently and concisely.\nRequires excellent organizational and interpersonal skills, team-player\nEDUCATION/EXPERIENCE\nAdvanced 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.\nBS/MS in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or other related fields with 5+ years’ experience in pharmaceutical development or CDMO industry\nA strong foundation in clinical-phase development and analytical characterization of drug products, including biologics and other complex modalities\nIn depth knowledge of biopharmaceutical and/or medical product regulation, formulation, filtration, filling, and lyophilization operations\nExperience with MS Office (Word/Excel/Teams/PowerPoint/SharePoint), SmartSheets, LabX, and Empower\nQUALITIES\nDetail oriented and a results driven team player\nAbility to work in a dynamic, fast paced work environment\nHonesty, integrity, respect and courtesy with all colleagues \nCreative with the ability to work with minimal supervision and balanced with independent thinking\nResilient through operational and organizational change\nPHYSICAL REQUIREMENTS\nAbility to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.\nAbility to gown and gain entry to controlled manufacturing areas.\nAbility to lift, pull or push equipment requiring up to 25-50 lbs of force\nAbility to stand for prolong periods in a production suite and work extended hours.\nCOMMUNICATIONS & CONTACTS\nWorks directly with Process Development personnel\nWorks closely with QCAD, VAL, MTS, and Operations \nWill interact with Customers on a regular basis\nMANAGERIAL & SUPERVISORY RESPONSIBILITIES\nRequired to lead and train junior level Process Development Scientists positions.\nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI 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.\nAt 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. 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