PurposeThe External Manufacturing and Alliance Manager is responsible for identifying, evaluating, and managing strategic partnerships with Contract Development and Manufacturing Organizations (CMOs) to support the company's pharmaceutical development and manufacturing needs. This role involves coordinating with internal stakeholders, scouting for potential CDMOs, negotiating contracts, and ensuring seamless execution of manufacturing agreements to align with business objectives. We are seeking demonstrated expertise in placing / awarding products to CMOs and successful commercialization track record.
Position / Job TitleManager - External Manufacturing and Alliance
DepartmentBusiness Development / External Manufacturing
Reporting ToHead Business Development
LocationThane
Years of ExperienceMinimum 10 years
Dosage Form-NA-
Job Responsibilities / Deliverables
CDMO Identification & Evaluation
- Gather and analyze all relevant product details from R&D to define manufacturing requirements.
- Receive demand forecasts from Business Development (BD) to align with sourcing strategies.
- Identify and evaluate CMOs offering the required services, ensuring regulatory
compliance and technical capabilities.
- Initiate communication with prospective CMOs to assess fitment.
Contractual & Financial Management
- Facilitate the execution of Confidentiality Disclosure Agreements (CDA) to enable data sharing.
- Compile Request for Quotation (RFQ) documents in collaboration with R&D, ensuring all technical and commercial requirements are captured.
- Share RFQ with selected CMOs and request competitive quotes.
- Obtain key background documents such as FDA audit reports, EIRs, and other
regulatory compliance details.
- Negotiate best pricing, payment terms, and service levels to optimize costs and
efficiency.
- Compare and contrast at least three proposals to facilitate data-driven decision-
making.
- Facilitate contract negotiations, term sheets, and formal agreements in coordination
with Legal and Finance teams.
Alliance & Relationship Management
- Build and maintain strategic relationships with CMOs to ensure long-term collaboration.
- Establish a structured repository of all identified CDMOs globally, including key
contacts, capabilities, and past performance records.
- Act as the key liaison between internal teams (R&D, BD, Finance, Regulatory) and external manufacturing partners to ensure smooth execution of projects.
- Participate in Steering Committee (SteerCo) meetings to report on project progress, challenges, and strategic recommendations.
Operational & Compliance Oversight
- Ensure accurate billing and payables for CMO engagements, coordinating with Finance for timely payments.
- Share Management Information System (MIS) reports with Project Management Head, R&D Head, and Business Finance on a fortnightly basis, tracking key performance indicators (KPIs).
- Monitor CMO performance, adherence to quality and compliance standards, and escalate any concerns to relevant stakeholders.
- Track industry trends, regulatory changes, and competitive landscape to refine the CMO selection strategy.
- Support Business Development and Supply Chain teams in aligning external
manufacturing capabilities with long-term growth plans
Qualifications & Pre-Requisites
- Education: Bachelor's/Master's degree in Pharmacy, Chemistry, Business
Administration, or a related field.
- Experience: 10+ years of experience in external manufacturing, business development, or alliance management within the pharmaceutical industry.
- Technical Knowledge: Strong understanding of pharmaceutical manufacturing
processes, CMO operations, and regulatory requirements (FDA, EMA, cGMP, etc.).
- Negotiation Skills: Proven experience in contract negotiation, cost optimization, and vendor management.
Feb 2025
- Analytical Abilities: Ability to evaluate proposals, compare pricing structures, and
make strategic decisions.
- Communication & Collaboration: Excellent stakeholder management skills to
coordinate cross-functional teams and external partners.
- Project Management: Strong organizational skills to manage multiple engagements, timelines, and deliverables effectively.
- Tech-Savvy: Proficiency in Microsoft Office, ERP systems, and contract management tools
Additional Notes
- Opportunity to work with leading pharmaceutical manufacturing partners worldwide.
- Strategic role in shaping external manufacturing alliances to drive business growth.
- Exposure to cross-functional teams and leadership discussions in a dynamic industry.