Development Scientist II, Analytical Development and Clinical QC (ADQC)

BioCT; New Haven (CT); On-site; USD 112,000 - 168,000; Full time

Job summary

BioCT is seeking a Development Scientist II to provide scientific and operational oversight of external analytical laboratories supporting biologic drug substances and products. You will lead investigations, review data and documentation, and collaborate across QA, stability, manufacturing, and regulatory teams to ensure timely, compliant outcomes.

You will drive continuous improvement of external laboratory oversight, contribute to regulatory submissions, and support audits with scientifically

Qualifications

• Ph.D. in Biochemistry, Chemistry or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands-on biological analytical development experience.
• Experience supporting GMP analytical testing for biologic products.
• Experience leading or supporting lab investigations (OOS, OOT, atypical) with root-cause analysis.
• Strong data evaluation, report writing, and technical documentation skills.
• Knowledge of GMP, FDA, ICH, USP, and EP expectations.

Responsibilities

• Provide scientific and operational oversight of external analytical labs.
• Lead investigations from initiation to closure, including OOS/OOT, with justified strategies.
• Coordinate testing activities and timelines with contract laboratories and internal partners.
• Review protocols, raw data, COAs, and stability data for disposition and regulatory commitments.
• Drive continuous improvement in external lab oversight and documentation processes.
• Support audit, inspection, and regulatory readiness with complete and traceable records.

Skills

Analytical oversight

Lab investigations

Scientific writing

Cross-functional collaboration

Quality control

Education

Ph.D. in Biochemistry/Chemistry or related

M.S. with 10+ years hands-on experience

Tools

Veeva Vault Quality

LIMS systems

ValGenesis

Kneat

Job description

This is what you will do:

The Development Scientist II will play a highly visible role in ensuring that analytical quality control testing performed by external laboratories is scientifically sound, compliant, and delivered to ultimately serve patients.

As a member of the External Analytical Development and Quality Control team, you will provide end-to-end scientific and operational oversight of Good Manufacturing Practice analytical activities supporting biologic drug substance and drug product programs. You will work directly with contract laboratories and internal partners to manage analytical testing, investigate unexpected results, evaluate scientific data, and deliver the documentation needed to support batch release, stability programs, regulatory submissions, and product lifecycle activities.

This is an opportunity to become a trusted scientific partner across a global external laboratory network. You will have the autonomy to lead complex analytical investigations, solve challenging laboratory problems, influence how external testing is performed, and improve the systems used to bring important therapies to patients.

You will be responsible for:

• Providing scientific and operational oversight of external analytical laboratories performing release, stability, characterization, verification, validation, and investigational testing for biologic drug substance and drug product programs.
• Leading laboratory investigations from initiation through closure, including Out-of-Specification, Out-of-Trend, and atypical analytical results. You will develop scientifically justified investigation strategies, evaluate potential root causes, assess product impact, and support appropriate corrective and preventive actions according to current compliance guidance.
• Serving as a primary technical liaison with contract laboratories, translating internal program requirements into clear testing requests, deliverables, timelines, and documentation expectations while resolving scientific, quality, and operational issues that could affect critical program milestones.
• Reviewing analytical data and technical documentation, including protocols, raw data, investigation reports, method verification and validation reports, stability data, Certificates of Analysis, and other records needed to support material disposition and regulatory commitments.
• Coordinating external testing activities across multiple programs, proactively tracking testing status, laboratory investigations, analytical reports, sample requirements, documentation, and critical-path deliverables. You will communicate risks early and establish practical plans to keep work moving.
• Partnering with Quality Assurance, Stability, Manufacturing, Analytical Development, Regulatory, and program teams to align investigation strategies, evaluate analytical risks, resolve documentation gaps, and ensure timely delivery of compliant analytical data.
• Driving continuous improvement of external laboratory oversight, including development of investigation checklists, templates, tracking tools, performance measures, and standardized ways of working that improve investigation quality, documentation consistency, and cycle time.
• Supporting audit, inspection, and regulatory readiness by ensuring that external analytical records are complete, traceable, scientifically defensible, and readily available for health authority requests, internal audits, and regulatory submissions.

You will need to have:

• Advanced (Ph.D.) degree in Biochemistry, Chemistry or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands on biological analytical development experience in pharmaceutical industry.
• Demonstrated experience supporting Good Manufacturing Practice analytical testing for biologic drug substance, drug product, or other complex pharmaceutical products.
• Experience leading or supporting laboratory investigations involving Out-of-Specification, Out-of-Trend, atypical, invalid, or unexpected analytical results, including root-cause analysis, impact assessment, result disposition, and corrective or preventive action development.
• Demonstrated strong mental acuity, high attention to detail, ability to evaluate analytical data, recognize unexpected assay behavior, develop scientifically justified investigation plans, and communicate conclusions through clear technical documentation.
• Working knowledge of current Good Manufacturing Practice requirements and applicable United States Food and Drug Administration, International Council for Harmonisation, United States Pharmacopeia, and European Pharmacopoeia expectations.
• Experience managing multiple analytical activities, investigations, and documentation deliverables concurrently while maintaining quality and meeting time-sensitive program commitments.
• Effective scientific writing, presentation, and communication skills, with the ability to lead technical discussions involving external laboratories and cross-functional stakeholders. Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, Teams, and collaborative document-management tools is required.
• The duties of this role are generally conducted in an office and laboratory environment. Candidates must have the ability to bend, reach and stand, with lifting up to 15 pounds and carry over short distances.
• Ability to travel up to 10%, if needed.

We would prefer for you to have:

• Experience providing technical oversight of testing performed by external contract laboratories or contract development and manufacturing organizations.
• Experience with analytical methods used to evaluate biologic products, such as chromatography, electrophoresis, potency or binding assays, particulate testing, compendial testing, and microbiological methods.
• Experience generating, reviewing, or approving Certificates of Analysis and analytical documentation supporting batch release and stability programs.
• Experience with electronic quality and document-management systems such as Veeva Vault Quality, Laboratory Information Management Systems, ValGenesis, Kneat, or comparable validated platforms.
• Experience supporting analytical method transfer, method verification, method validation, stability testing, process performance qualification, or clinical-to-commercial program transitions.
• Experience preparing analytical data packages or technical documentation for regulatory submissions, health authority responses, audits, or inspections.
• Experience using data-analysis and visualization tools such as JMP, Tableau, or comparable statistical software.
• Experience improving laboratory investigation processes, external laboratory governance, analytical tracking systems, or standardized technical workflows.

The annual base pay (or hourly rate of compensation) for this position ranges from $112,304.00 - $168,456.00 USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

05-Nov-2026

Closing Date

12-Nov-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.