External Manufacturing Operations (EMO), Senior Manager

Description

Company Overview

Creating a Healthier World through Accessible Biologics:

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Position Summary - 

The Senior Manager, External Manufacturing Operations (EMO) is the primary operational contact for assigned contract manufacturing organizations (CMOs/CDMOs), products, and manufacturing programs. This hands-on role coordinates routine manufacturing execution, technology transfer, campaign readiness, issue resolution, and partner performance to support reliable supply and compliant delivery of biologic drug substance and/or drug product.

The Senior Manager works through a matrix and partners closely with Manufacturing, Quality, MSAT, Supply Chain, Regulatory, CMC Development, Procurement, Legal, and Finance. The role executes approved external-manufacturing strategy for an assigned portfolio, recommends improvements, and escalates decisions that require broader network, contractual, financial, or product-disposition authority. During critical campaigns, the Senior Manager may provide on-site person-in-plant support at external manufacturing facilities.

What You Will Own

• Day-to-day operational governance of assigned CMO/CDMO relationships, products, and manufacturing campaigns.
• Manufacturing schedules, readiness milestones, action tracking, risk visibility, and cross-functional follow-through for the assigned portfolio.
• Routine partner meetings, operational reviews, escalation coordination, and performance reporting.
• Operational support for technology transfer, validation, process changes, investigations, and continuous improvement.
• Clear communication of manufacturing status, supply risks, decisions, and required actions to internal stakeholders and leadership.

Essential Duties & Responsibilities:

CMO Operations and Partner Performance

• Serve as the primary operational contact for assigned external manufacturing partners and maintain productive, accountable working relationships.
• Coordinate day-to-day manufacturing activities against approved production schedules, supply priorities, quality requirements, and program objectives.
• Lead routine operating meetings and contribute to quarterly or periodic business reviews using agreed metrics, risks, actions, and decisions.
• Monitor partner performance, including schedule adherence, on-time delivery, yield, right-first-time execution, deviation closure, and action-item completion.
• Identify execution risks early, develop practical mitigation plans with internal and external teams, and escalate issues through the appropriate governance pathway.
• Provide on-site person-in-plant support during selected engineering, validation, clinical, or commercial manufacturing campaigns when needed.

Technology Transfer and Manufacturing Execution

• Coordinate operational readiness for technology transfers, scale-up, process validation, PPQ, new-product introductions, and lifecycle changes at assigned CMOs.
• Partner with MSAT, CMC Development, Engineering, Quality, and Regulatory colleagues to confirm that technical deliverables, documentation, materials, equipment, training, and facility readiness are aligned before execution.
• Track transfer plans, validation milestones, dependencies, risks, and decisions; maintain clear ownership and due dates across the project team.
• Support manufacturing troubleshooting and facilitate timely resolution of technical and operational issues without replacing the accountable Quality, MSAT, Regulatory, or product-disposition functions.
• Capture lessons learned and implement repeatable tools, templates, and operating practices across the assigned portfolio.

Quality, Compliance, and Regulatory Support

• Ensure assigned manufacturing activities are planned and executed in accordance with cGMP, approved procedures, quality agreements, and applicable regulatory requirements.
• Partner with Quality to support deviations, investigations, CAPAs, change controls, complaints, audits, and inspection-readiness activities.
• Monitor the operational impact of quality events and coordinate recovery plans that protect patients, product quality, compliance, and supply continuity.
• Participate in audits and regulatory inspections as an operations representative or subject-matter contributor when requested.

Supply, Cost, and Cross-Functional Coordination

• Partner with Supply Chain to align demand, production, release, shipment, inventory, and material-readiness requirements for assigned products.
• Provide timely visibility to capacity constraints, schedule changes, material risks, and potential supply interruptions.
• Track costs, purchase-order or statement-of-work milestones, and budget impacts within the assigned portfolio; partner with Finance, Procurement, and Legal on commercial decisions and contract changes.
• Identify practical opportunities to improve cost, efficiency, cycle time, quality, and partner performance, and develop recommendations for leadership approval when required.
• Communicate clearly across Manufacturing, Quality, Regulatory, Supply Chain, MSAT, R&D, CMC Development, Finance, Procurement, and Legal.

Role Scope and Decision Boundaries  

• The initial scope is a defined portfolio of assigned CMO/CDMO partners, products, or programs, with the opportunity to expand as the external-manufacturing portfolio grows.
• The Senior Manager executes approved strategy and recommends changes. Network strategy, major capital decisions, final contract authority, and enterprise portfolio prioritization remain with senior leadership and the appropriate functional owners.
• The role leads primarily through matrix influence. Direct supervisory responsibility may be added as the organization and portfolio grow.
• Quality retains independent authority for quality-system decisions and product disposition. The Senior Manager coordinates operational response and supply recovery in partnership with Quality and other accountable functions.

Requirements

Position Requirements and Qualifications

Minimum Qualifications:

Education:

• Bachelor's degree in engineering, biotechnology, biology, biochemistry, pharmaceutical sciences, life sciences, or a related discipline.

Experience:

• At least 10 years of experience in biomanufacturing, pharmaceutical manufacturing, technical operations, MSAT, supply operations, or another regulated life-sciences environment.
• At least 8 years of experience working in a GMP-regulated environment.
• Meaningful experience supporting or managing external manufacturing, CDMO/CMO relationships, outsourced manufacturing programs, or sponsor-CDMO operations.
• Working knowledge of biomolecule manufacturing, including one or more of the following: cell culture, fermentation, purification, formulation, aseptic processing, fill-finish, or biologic drug-product manufacturing.
• Experience coordinating manufacturing schedules, campaign readiness, technology transfer, validation, change control, deviations, CAPAs, or lifecycle activities.
• Demonstrated ability to lead cross-functional work through influence, establish accountability, resolve issues, and communicate effectively with technical and business stakeholders.
• Ability to travel occasionally and provide on-site support at external manufacturing facilities during critical activities.

Preferred Qualifications: 

• Master's degree, MBA, or other relevant advanced degree.
• Three or more years of direct experience coordinating or managing one or more biologics CMO/CDMO relationships or outsourced manufacturing programs.
• Experience supporting clinical and/or commercial biologics, biosimilars, vaccines, cell and gene therapies, or other complex sterile products.
• Experience with partner scorecards, operational reviews, supply-risk mitigation, statements of work, purchase orders, cost tracking, or capacity planning.
• Experience serving as a technical or operational lead during CMO manufacturing campaigns, technology transfers, validation, PPQ, inspections, or major investigations.
• People leadership, mentoring, or team-development experience. Formal direct-report management is helpful but not required if strong matrix leadership is demonstrated.

Compensation:

• ·External Manufacturing Operations (EMO), Senior Manager – Base Salary Range and Yearly Cash Bonus – 10 years or more of manufacturing biologics/biosimilars experience - $160,000 to $180,000 (dependent on years of experience and fit for the position) with up to a 15% yearly (discretionary) cash bonus

Benefits/Perks:

• Medical Insurance - Aetna
  • Prescription Drug Converge | Rx
  • Virtual Visits - Aetna/Teladoc
  • Health Savings Accounts (HSA)
  • Flexible Spending Accounts (FSA)
• Dental Insurance - Aetna
• Vision Insurance - VSP
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits
  • Legal Services
  • ID Theft Protection
  • Travel Assistance
• Value Added Benefits & Services
  • Health Advocate
  • Life Assistance Program (LAP)
  • Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance

Hours:

This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• Work is performed in office and operational manufacturing environments.
• The position requires movement through manufacturing facilities and the ability to lift at least 25 pounds.
• Occasional travel is required. Additional on-site presence may be necessary during selected manufacturing campaigns, technology transfers, investigations, or inspections.
• The role operates in a fast-paced environment with time-sensitive manufacturing, quality, and supply priorities.

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.