Pharmaceutical Alliance and Manufacturing Development Lead
7 days ago
About Rubicon Research
Rubicon Research Limited is a leading pharmaceutical formulation company delivering value to our customers and investors through the development, manufacturing, and marketing of branded specialty and generic prescription pharmaceutical products in regulated markets.
Our portfolio comprises over 250 SKUs across more than 70 product families, with an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma and Validus Pharmaceuticals.
We have two FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India, with multiple accreditations from regulatory agencies such as the US FDA, WHO-GMP, and Health Canada.
Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms, ensuring compliance with industry standards.
The External Manufacturing and Alliance Manager plays a pivotal role in identifying, evaluating, and managing strategic partnerships with Contract Development and Manufacturing Organizations (CDMOs) to support our 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.
Key Responsibilities:
- Gather and analyze product details from R&D to define manufacturing requirements.
- Receive demand forecasts from Business Development to align with sourcing strategies.
- Identify and evaluate CMOs offering required services, ensuring regulatory compliance and technical capabilities.
- Initiate communication with prospective CMOs to assess fitment.
- 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.
- Build and maintain strategic relationships with CMOs to ensure long-term collaboration.
- Establish a structured repository of identified CDMOs globally, including key contacts, capabilities, and past performance records.
- Act as the key liaison between internal teams and external manufacturing partners to ensure smooth execution of projects.
- Participate in Steering Committee meetings to report on project progress, challenges, and strategic recommendations.
- Ensure accurate billing and payables for CMO engagements, coordinating with Finance for timely payments.
- 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.
Key Qualifications & Skills:
- 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.
- 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.
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Mumbai, Maharashtra, India Rubicon Research Limited Full timeAbout Rubicon Research Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product...
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Mumbai, Maharashtra, India Rubicon Research Limited Full timeAbout Rubicon Research Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product...
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Mumbai, Maharashtra, India Rubicon Research Limited Full timeAbout Rubicon ResearchRubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.Our product portfolio comprises over 250 SKUs across more than 70 product...
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Mumbai, Maharashtra, India Rubicon Research Limited Full timeAbout Rubicon Research Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product...
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Mumbai, Maharashtra, India Rubicon Research Limited Full timeAbout Rubicon ResearchRubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.Our product portfolio comprises over 250 SKUs across more than 70 product...
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Mumbai, Maharashtra, India Rubicon Research Limited Full timeAbout Rubicon Research Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product...
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Mumbai, Maharashtra, India Rubicon Research Limited Full timeRole OverviewThe External Manufacturing and Alliance Manager is responsible for identifying, evaluating, and managing strategic partnerships with Contract Development and Manufacturing Organizations (CDMOs) to support the company's pharmaceutical development and manufacturing needs.This role involves coordinating with internal stakeholders, scouting for...
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