Cronus Pharma is an integrated animal health pharmaceutical company with R&D;, manufacturing, and marketing capabilities, headquartered in East Brunswick, NJ. The company focuses on delivering high-quality, cost-effective pharmaceuticals for companion animals, equine, and production animals. Cronus India has an integrated manufacturing and R&D; setup in GMR Airport SEZ.

- About the RoleWe are hiring for a Sr. Manager, Project Management. This is a senior leadership role within the R&D; Department, responsible for driving the end-to-end project management of pharmaceutical product development programs across multiple dosage platforms. The position demands a high degree of scientific acumen, operational discipline, and the ability to orchestrate complex multi-functional teams in a quick-paced development environment.

Reporting directly to the Chief Scientific Officer (CSO), the Project Manager will serve as the central nerve of the formulation pipeline — translating scientific objectives into executable project plans, managing timelines and resources with precision, interfacing with all Cross functional team both at in-house facility and Contract Manufacturing and Development Organisations (CMO/CDMOs), and ensuring programs are delivered in full compliance with GMP and regulatory expectations for regulated markets including the USA and Europe.

Location: Hyderabad, India Function: R&D; Department Reports to: Chief Scientific Officer (CSO) Employment type: Full-time, On-site Experience: ~15 years Designation - Sr. Manager, Project Management

Key dosage form scope

OSD | Injectables | Complex Injectables | Liquid Orals | Pour-On Solutions | Semisolids | Animal Health Products (Advantage)

- Key Responsibilities2.1 DEVELOPMENT PROJECTS LEADERSHIP
- Own and drive end-to-end project management for all R&D; programs — from pre-formulation, prototype development, pilot batches, scale-up, and tech transfer through to commercial manufacturing readiness.
- Develop comprehensive integrated project plans with milestone schedules, resource matrices, risk registers, and budget tracking for each program across all dosage platforms.
- Lead stage-gate reviews at each development phase with structured go/no-go decision frameworks aligned to business priorities and regulatory requirements.
- Monitor execution of formulation feasibility studies, prototype screening, pre-formulation characterization, excipient compatibility, and stability programs — ensuring timely completion and documentation.
- Oversee preparation and quality review of development reports, batch manufacturing records (BMRs), master batch records, and technical packages for regulatory submission.

2.2 CROSS-FUNCTIONAL COORDINATION

- Lead cross-functional project teams spanning Formulation Development, Analytical Development, Process Development, Quality Assurance, Regulatory Affairs, and Manufacturing.
- Facilitate weekly project team meetings, monthly program reviews,



and quarterly portfolio governance sessions; maintain action trackers and ensure accountability across all functions.
- Proactively identify and resolve inter-departmental bottlenecks, resource conflicts, and schedule risks; escalate to the CEO with options and recommendations.
- Collaborate with Analytical Development to ensure method development, validation timelines, and stability-indicating methods are aligned to the formulation development schedule.
- Work with QA to ensure all formulation activities comply with GMP requirements and that deviations, CAPAs, and change controls are resolved without impacting program timelines.

2.3 TECHNOLOGY TRANSFER & SCALE-UP

- Plan and execute technology transfer activities from lab scale to pilot scale and commercial manufacturing — for internal facilities and external CMO sites.
- Author or coordinate tech transfer protocols, process descriptions, equipment comparability assessments, and site-specific adaptation documents.
- Resolve scale-up challenges by liaising between formulation scientists and manufacturing teams; track open items to closure with defined owners and due dates.
- Support process validation planning (PPQ), cleaning validation alignment, and manufacturing readiness reviews prior to commercial launch.

2.4 CMO MANAGEMENT & EXTERNAL COORDINATION

- Act as the primary project interface with Contract Manufacturing Organisations (CMOs) for outsourced formulation development, scale-up, and manufacturing campaigns.
- Establish joint project governance with CMOs: structured meeting cadences, shared milestone trackers, escalation paths, and change control procedures.
- Monitor and hold CMOs accountable to agreed timelines, batch outputs, quality standards, and regulatory compliance obligations.
- Coordinate CMO qualification and audit activities with the QA team; track gap closure post-audit and ensure readiness for regulatory inspections at CMO sites.
- Manage scope changes, budget impacts, and contractual deliverables arising from CMO program modifications in coordination with procurement and legal.

2.5 REGULATORY & QUALITY ALIGNMENT

- Ensure all formulation development programs comply with US FDA 21 CFR Parts 210/211, EU GMP (EudraLex Vol. 4), and ICH Q8/Q9/Q10/Q11 guidelines.
- Coordinate with Regulatory Affairs to align development activities with ANDA/NDA/505(b)(2)/MAA submission strategies and timelines.
- Ensure CMC (Chemistry, Manufacturing, and Controls) sections are well-supported by development data and are submission-ready on schedule.
- Support inspection readiness for US FDA, EMA,



and other regulated market agency visits — including documentation audits and mock inspection participation.

2.6 CEO REPORTING & STRATEGIC PLANNING

- Prepare concise, decision-ready portfolio status reports and dashboards for the CEO covering milestone status, risk flags, resource utilisation, and financial burn vs. plan.
- Support the annual R&D; portfolio planning cycle — evaluating pipeline priorities, capacity constraints, and investment allocation in collaboration with the CEO.
- Contribute to make-vs.-buy decisions for new programs by evaluating internal capability gaps and CMO landscape options.

2.7 ANIMAL HEALTH PROJECTS (ADDED ADVANTAGE)

- Manage development programs for veterinary pharmaceutical products including Pour-On solutions, injectable veterinary formulations, oral liquids, and Oral Pastes, Soft Chews across companion animal and livestock species.
- Coordinate with regulatory teams on USDA/FDA-CVM (US) and EMA-CVMP (EU) submission strategies and development data requirements specific to animal health products.
- Liaise with veterinary science and animal health business teams to align product development priorities with market and registration timelines.
- Qualifications & Experience Requirements

Education: B.Pharm / M.Pharm / M.Sc. Pharmaceutical Sciences or Chemistry

Higher qualification: Ph.D. in Pharmaceutical Sciences preferred; MBA (Operations) is a plus

PM certification: PMP (PMI) / PRINCE2 preferred

Total experience: ~15 years in pharmaceutical industry quirem

- Core CompetenciesTECHNICAL KNOWLEDGE
- Pharmaceutical formulation science across multiple dosage forms (solid, liquid, sterile)
- CMC development strategy and regulatory data package preparation
- GMP, GDP, and quality systems in pharmaceutical R&D;
- Quality by Design (QbD) principles — QTPP, CQA, CPP, DoE
- Technology transfer and process validation lifecycle (IQ/OQ/PQ/PPQ)
- Stability study design per ICH Q1A/Q1B requirements

PROJECT & PROGRAMME MANAGEMENT

- Integrated project planning, milestone management, and critical path analysis
- Risk identification, assessment, and mitigation planning
- Resource planning and capacity management across concurrent programs
- Budget tracking, financial accountability, and cost-to-complete forecasting
- Stage-gate and portfolio governance framework design and execution
- Change control and scope management in development environments

LEADERSHIP & STAKEHOLDER MANAGEMENT

- Executive communication and C-suite / CEO-level reporting
- Cross-functional leadership without direct authority
- CMO and vendor relationship management
- Conflict resolution, negotiation, and stakeholder alignment

BEHAVIOURAL ATTRIBUTES

- High ownership and accountability mindset
- Structured analytical thinking and problem solving under ambiguity
- Detail-oriented while maintaining strategic perspective
- Strong written and verbal communication in English

📌 Senior Manager - Project Management, R&D (Hyderabad)
🏢 Cronus Pharma
📍 Hyderabad