Job Title - Scientist l-II, QC Functional Lead
Work Location - Cranbury NJ
Job SummaryThe QC Functional Lead Training Program develops scientifically strong M.S. and Ph.D. candidates into Quality Control functional leads who can coordinate analytical strategy, testing execution, timelines, documentation, and client deliverables across biologics programs. The program supports both recent graduates and experienced hires through an initial competency assessment and a role-specific development plan.
The Scientist I or Scientist II serves as the QC functional lead for assigned projects and works closely with QC testing functions, Analytical Development, Process Development, MSAT, Manufacturing, Quality Assurance, Project Management, CMC leaders, and client teams. The role supports method transfer and qualification strategy, in-process, release, and stability testing, investigations, documentation, and delivery of complete QC data packages in accordance with approved procedures and cGMP requirements.
Training Program StructureTraining is organized into required and assignment-specific modules. Each module combines scientific theory, data or case-based instruction, supervised practice, and mentored application to active or simulated QC projects.
- Required scientific and QC foundation: All participants complete training in biotechnology and protein therapeutics, critical quality attributes, analytical control strategy, product lifecycle, and the purpose of in-process, release, stability, characterization, and comparability testing.
- Required compliance and documentation foundation: All participants complete cGMP, Good Documentation Practices, ALCOA+ data integrity, laboratory safety, controlled records, investigation fundamentals, and applicable regulatory and compendial training.
- Assignment-specific technical modules: PCT, BIT, separation-assay, bioassay, impurity-testing, method-transfer, qualification, and other special-topic modules are assigned according to the candidate's project scope and technical responsibilities at hiring.
- Functional lead practice and qualification: Recent graduates complete the full curriculum and progress from shadowing to ownership of defined deliverables. Experienced hires complete a structured gap assessment and accelerated training where appropriate. All participants must demonstrate readiness through reviewed work products and a mentored QC project before independent assignment.
Job Responsibilities- Complete the assigned training curriculum, technical modules, supervised activities, and functional lead qualification; maintain current training status for applicable procedures and systems.
- Serve as the QC functional lead for assigned biologics projects and coordinate integrated or standalone QC deliverables, priorities, timelines, risks, and communications.
- Lead matrix teams across Analytical Development and QC testing functions to establish and execute method-transfer, qualification, and analytical lifecycle strategies.
- Prepare or coordinate sampling plans, specifications, release and stability protocols, technical summaries, certificates, and other project documentation in a timely and compliant manner.
- Manage in-process, release, stability, and assigned cell-bank testing; coordinate external laboratory selection, sample shipment, oversight, and result integration when required.
- Lead or participate in OOS, OOT, laboratory-deviation, and other investigations; support root-cause analysis, impact assessment, CAPA, change control, and effective closure.
- Ensure that training, testing, documentation, laboratory-management, and data-integrity activities meet approved procedures, industry standards, and applicable regulatory expectations.
- Communicate effectively with internal and external clients, lead technical discussions, prepare project updates, and support audits, inspection readiness, and laboratory operational-excellence activities
Technical Training and Functional Lead ScopeScientific and QC Operations- Biologics QC, protein therapeutics, critical quality attributes, and analytical control strategy
- In-process, release, stability, characterization, comparability, and cell-bank testing
- Sampling plans, specifications, test protocols, certificates, and data-package readiness
- Method transfer, qualification, validation support, lifecycle management, and change control
- Scientific data review, result trending, OOS/OOT assessment, deviations, CAPA, and risk evaluation
- Sample, stability-sample, reference-standard, inventory, LIMS, equipment, and record-management fundamentals
Project and Client Leadership- Project scope, schedules, priorities, risk registers, action tracking, and on-time delivery
- Cross-functional leadership across QC, AD, PD, MSAT, Manufacturing, QA, PM, and CMC teams
- Client communication, technical discussions, written updates, recommendations, and issue escalation
- External CRO selection and oversight, sample shipment, testing coordination, and result integration
- Audit and inspection readiness, project metrics, management reporting, and laboratory operational excellence
- Mentored ownership of a representative QC project or project phase before independent assignment
Required Qualifications- M.S. or Ph.D. in Biology, Cell Biology, Biochemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.
- Prior pharmaceutical or biotechnology industry experience is not required for program entry. Level placement and the development plan are based on education, relevant experience, demonstrated competencies, and role readiness.
- Strong scientific reasoning, problem-solving, organization, and the ability to interpret analytical data and connect results to product quality and project decisions.
- Ability to learn and apply regulated laboratory practices, cGMP requirements, Good Documentation Practices, data-integrity principles, and controlled project procedures.
- Effective written and verbal communication, attention to detail, learning agility, and the ability to manage multiple priorities in a fast-paced matrix environment.
Preferred Qualifications- Experience with biologics analytical development, QC operations, method transfer, qualification or validation, release or stability testing, or laboratory investigations.
- Familiarity with protein or cell-based analytical methods, chromatography or plate-reader data systems, LIMS, electronic laboratory systems, or electronic quality-management systems.
- Experience supporting clinical or commercial manufacturing, external laboratories, regulatory submissions, audits, inspection readiness, or client-facing project work.
- Demonstrated project leadership, technical writing, mentoring, decision-making, or cross-functional coordination experience.
Core Competencies- Scientific and quality judgment
- Quality and compliance mindset
- Data integrity and documentation excellence
- Project ownership and on-time delivery
- Technical problem solving and sound decision-making
- Client communication and influence
- Cross-functional collaboration and team leadership
- Adaptability, learning agility, and continuous improvement
The anticipated salary range for this position is $60,000 - $105,000 
