Analytical LCM Product Lead - Biologics

BioLife Plasma; Lexington (MA); On-site; USD 220,000 - 320,000; Full time

Job summary

BioLife Plasma is seeking a Senior Director to lead Biologics Analytical LCM Oversight, driving strategy across development and lifecycle management. You will manage program leads, align with QA/QC/Regulatory/IT, and push AQbD and risk-based decisions to ensure robust control strategies for monoclonal antibodies, ADCs, and related biologics.

You will foster cross-functional collaboration, advance analytical technology, and build a leadership network to deliver scalable, compliant solutions

Qualifications

• BS/MS in Biochemistry, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, or related discipline; PhD preferred.
• 12+ years in pharma/biotech with depth in Analytical Development and/or QC, leading multiple biologics analytical programs.
• Experience developing analytical and holistic control strategies and supporting regulatory submissions (IND/IMPD/BLA/MAA).
• Strong understanding of AQbD, risk-based validation/verification, robustness, and method lifecycle management.
• Broad oversight across biologics analytical modalities and enabling systems (CDS/LIMS/ELN).
• Experience supporting regulatory submissions and approvals.
• Strong communication and stakeholder management.
• Platform modernization and scaling new analytical approaches.

Responsibilities

• Own the global Analytical LCM Biologics Portfolio Strategy from late development through commercial.
• Maintain program roadmaps and Method Risk Registers with cross-functional alignment.
• Collaborate with QA, QC, Regulatory, IT to ensure integrated control strategies.
• Directly lead and develop Analytical LCM program leads and establish accountability.
• Drive analytical technology innovation and platform embedding in LCM plans.

Skills

Strategic leadership

Cross-functional collaboration

Regulatory submissions

AQbD / risk-based thinking

Analytical method development

Communication skills

Project management

Education

BS/MS in Biochemistry/related field

PhD preferred

Tools

CDS

LIMS

ELN

Job description

# **About the role:** * **Biologics Portfolio LCM Analytical Oversight:** Single point of accountability for all Analytical LCM Biologics programs. Direct people management of individual analytical LCM program leads to provide deep technical, quality, and regulatory insights that drive consistent and scientifically sound decisions.* **Owns and drives Analytical LCM Portfolio Program Strategies for Biologics programs:** Deep understanding of individual biologics product control strategies, working with individual biologics analytical LCM program leads to ensure all analytical LCM activities are covered and on track with clearly defined roles and responsibilities, schedules, and resources. Creates and maintains Analytical LCM program roadmaps and method risk registers in alignment with overall CMC program roadmaps, and provides direct line-functional leadership for all Analytical LCM program representatives — ensuring consistent scientific direction, portfolio prioritization, capability building, and clear accountability for program deliverables.* **Analytical LCM Functional & Enterprise Leader:** Works in strong collaboration and communication with the Analytical LCM Portfolio Leader, other Analytical LCM Modality Leads, MSAT Manufacturing Leads, Pharm Sci Analytical, QC sites, and internal and external analytical labs and services to align on ways of working, biologics analytical prioritization, network strategy, CMC biologics initiatives/roadmaps, and analytical lab work resourcing.* **Tech Forward:** Drives digital-forward analytical technology innovation and platform embedment in analytical methodology. Works in collaboration with key stakeholders from Pharm Sci to QC labs — including Quality, Regulatory, and IT — to pull the latest analytical methodology through into LCM control strategies.* **Strategic and technical people leader** for biologics portfolio analytical development technical and product strategies, roadmaps, and initiatives. Embeds AQbD and risk-based thinking in method development, qualification/validation, and lifecycle management to improve robustness, reduce investigations, and accelerate tech transfer and comparability. # **How you will contribute:** * Single point of accountability for the global Analytical LCM portfolio of Biologics, including monoclonal antibodies, bispecific/multispecific antibodies, fusion proteins, recombinant proteins/enzymes, and antibody-drug conjugates (ADCs).* Owner of the Analytical LCM Biologics Portfolio Strategy from late development through commercial. Maintains deep analytical engagement with, and understanding of, product control strategies. Works with individual Analytical LCM program leads to create and maintain overarching program plans that meet overall CMC program plans. Provides oversight of each program’s Analytical LCM Roadmap and Method Risk Registers, driving communication and proactive planning to ensure appropriate analytical control strategies are in place for the lifetime of the commercial product.* Strong interface and communication with enterprise leaders across MSAT Analytical, MSAT Manufacturing, Pharm Sci, Quality, Regulatory, GSQ, QC sites, and IT to ensure program plans and needs are well integrated and resourced into existing and future control strategies.* Accountable for the integrated planning of ALL biologics program-specific analytical LCM activities to ensure continuity of control strategies — including methods, regulatory filings, justification of specifications, tech transfer, methods remediation planning, process changes, seamless supply, and bridging of control strategies for reference standards and key materials. Serves as analytical change control and comparability strategy owner and is ultimately accountable for biologics program-related analytical plans and execution of activities.* Coordination with Pharm Sci and Business Development to ensure incoming biologics program analytical strategies are consistently pulled through into commercial lifecycle management. Ensures analytical LCM plans and methods have appropriate quality management across the network, including standards, training, and inspection-readiness expectations for data integrity and documentation practices.* Oversight of biologics program method risk registers to monitor method performance and proactively implement measures to ensure products and methods remain in control for the lifetime of use.* Partner with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain, Pharm Sci, and IT to ensure submission-ready analytical sections, inspection readiness, and governance for change control and lifecycle management.* Contributes to driving analytical technology innovation into biologics analytical LCM program plans — in collaboration with Pharm Sci, the QC lab network, and other key stakeholders — ensuring appropriate product control, efficiency, compliance, and quality outcomes.* Builds and maintains a strong enterprise leadership network internally and externally to drive sound technical biologics program strategies, embedding AQbD, new technology, and risk-based thinking in method development, qualification/validation, and lifecycle management to improve robustness, reduce investigations, and accelerate tech transfer and comparability. # **Minimum Requirements/Qualifications:** * **Education:** BS/MS in Biochemistry, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, or a related discipline (PhD preferred).* **Experience:** 12+ years in pharma/biotech with depth in Analytical Development and/or QC, with emphasis on leading multiple biologics analytical programs in development and/or lifecycle management. Proficient across the breadth of biologics analytical technology applied to drug substance and drug product — especially cell-based bioassay/potency methods, separation sciences, mass spectrometry, and deep biophysical and biochemical characterization. Significant people and matrix leadership experience and accountability for strategy, governance, and delivery across multiple programs, including BLA or MAA filings.* **Control strategy & filings:** Demonstrated experience developing analytical and holistic control strategies and supporting regulatory submissions (IND/IMPD/BLA/MAA), including specifications/justifications, stability, and comparability strategies.* **AQbD / validation & lifecycle:** Strong understanding of ICH expectations and practical execution of AQbD, risk-based validation/verification, robustness, and method lifecycle management.* **Analytical platforms & informatics:** Strong technical oversight across key biologics analytical modalities and enabling systems (CDS/LIMS/ELN), including standardization and qualification in regulated environments.* **Analytical development breadth:** Understanding of analytical development supporting discovery through manufacturing and regulatory submissions.* **Regulatory support:** Experience supporting regulatory submissions and approval processes.* **Scientific leadership & stakeholder management:** Strong communication/collaboration; able to manage complex priorities and stakeholders.* **Platform modernization:** Track record modernizing analytical platforms or scaling new ways of working.