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Pharmaceutical Manufacturing Services Manager
1 week ago
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.
We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US.
We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms.
The External Manufacturing and Alliance Manager plays a critical role in 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 potential CDMOs, negotiating contracts, and ensuring seamless execution of manufacturing agreements to align with business objectives.
### Key Responsibilities:
- Gather and analyze all relevant product details from R&D to define manufacturing requirements
- Identify and evaluate CMOs offering the 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
- Negotiate best pricing, payment terms, and service levels to optimize costs and efficiency
- Build and maintain strategic relationships with CMOs to ensure long-term collaboration
- 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
Requirements:
- Bachelor's/Master's degree in Pharmacy, Chemistry, Business Administration, or a related field
- 10+ years of experience in external manufacturing, business development, or alliance management within the pharmaceutical industry
- Strong understanding of pharmaceutical manufacturing processes, CMO operations, and regulatory requirements (FDA, EMA, cGMP, etc.)
- Proven experience in contract negotiation, cost optimization, and vendor management
