Senior Manager, CMC & Development – Biosimilars

Adalvo is looking for a Senior Manager, CMC & Development – Biosimilars to join our team.

The selected candidate will lead the technical coordination and execution of CMC development activities for assigned biosimilar programs, spanning cell line development, drug substance and drug product processes, analytical development and biosimilarity assessment. Working with internal functions and external partners, the role will drive scientifically robust development, timely delivery and readiness for clinical supply, regulatory submission and commercial manufacturing.

We are flexible with the location of candidate selected for this role (within Europe and India) and we can accommodate home-based options.

ORGANIZATION STRUCTURE

Reporting line to be confirmed within the Biosimilars organization. The role will work closely with Regulatory Affairs, Quality, Clinical Development, Supply Chain and external development and manufacturing partners.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

· CMC planning: Lead biosimilar technical workstreams, plans, budgets and milestones; challenge study designs, partner data and conclusions, and close technical gaps.

· Cell line development: Oversee expression system/clone selection against productivity, stability and reference quality targets; review genetic stability and master/working cell bank establishment, characterization and manufacturing suitability.

· Drug substance: Oversee upstream/downstream development, scale-up/down models and characterization; assess process–CQA links, impurity clearance and viral safety; support control strategies and validation readiness.

· Drug product: Guide formulation, stability, container-closure compatibility, fill-finish and applicable device interfaces; review development/manufacturing data for quality, clinical supply and commercial readiness.

· Analytical development: Oversee orthogonal physicochemical/structural characterization, glycosylation, variants, impurities, potency and mechanism-relevant assays; review method qualification/validation/transfer, reference standards, specifications and stability.

· Biosimilarity/comparability: Coordinate reference sourcing, characterization and critical quality attribute (CQA) assessment to guide clone/process/analytical strategies; review risk-based similarity studies, statistics, differences and comparability after process/scale/site changes.

· Partners/manufacturing: Support partner/CDMO selection, technical scopes and on-time/on-budget deliverables; oversee transfer and site readiness; review transfer packages, manufacturing documents and deviations with Quality; support GMP batches and validation planning.

· Regulatory CMC: Review reports and contribute to CMC dossiers, scientific advice and authority responses with Regulatory Affairs; align development evidence, similarity conclusions and controls with submission commitments.

· Technical governance/risk: Resolve challenges through data and cross-functional collaboration; support investigations/change assessments; present options, comparability risks, costs and readiness recommendations at milestones; escalate promptly.

QUALIFICATIONS

· Education: Master’s in biotechnology, biochemistry, biochemical engineering, pharmaceutical sciences or related field, or equivalent scientific training/experience; PhD advantageous, not required.

· Experience: Typically 7+ years in biologics CMC/development, with direct biosimilar involvement and technical workstream delivery; submission, approval or commercial transfer experience advantageous.

· CMC breadth/depth: Knowledge of cell lines, upstream/downstream processing, drug product and analytical characterization; substantial hands-on depth in one area. Mammalian/microbial platform experience advantageous where relevant.

· Biosimilarity/comparability: Practical reference characterization, CQA assessment, analytical similarity and process-change comparability experience; interpret structural/functional/statistical data, challenge conclusions and inform development decisions.

· Regulatory/quality: Knowledge of EU/US biosimilar CMC expectations, relevant ICH guidelines, GMP, quality risk management and CMC documentation; submission, scientific advice or authority-response experience advantageous.

· External partners: Effective technical collaboration and deliverable assessment essential; third-party development/manufacturing management—including CDMO selection, scopes/budgets, transfer, site readiness, GMP manufacturing and validation—a strong advantage.

· Leadership/communication: Cross-functional workstream leadership, project management and scientific judgment; people management not required. Strong scientific writing, stakeholder communication and English; willingness to travel to partners as needed.

CORE COMPETENCIES

· Scientific rigor and sound, risk-based technical judgment

· Practical problem-solving

· Self-driven ownership and adaptability to work in a highly entrepreneurial environment

· Clear communication, timely escalation and results-oriented execution