Lead Associate / Lead External Manufacturing

We are seeking a Lead Associate / Senior Manager External Manufacturing to lead operations for North America, to ensure reliable supply of commercial products and support new product launches. The position manages relationships with Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs), driving operational excellence, compliance, and cost efficiency while collaborating with internal stakeholders across Quality, Supply Chain, Regulatory, Technical Services, and Commercial teams.

Responsibilities:

Supply Assurance & Operations

Coordinate with CMOs/CPOs to ensure on-time, in-full (OTIF) delivery of cGMP compliant , and quality reviewed and released FG and Bulk drug products to customers and markets

Determine supply priorities through interaction with the Global Supply chain and External Manufacturing (EM) team members on a regular basis and communication of these priorities and changes to the relevant CMO/CPO

Understand CMO’s capacity constraints , bottlenecks, material shortages etc. in the short medium and long term, aid resolution of these constraints & escalate to the supply chain management as needed

Manage the commercial product lifecycle , including raw material changes, artwork updates, process revalidations, packaging changes, and shelf-life extensions

Prepare and provide accurate monthly forecasts, purchase orders, and stock-transfer orders to the CMO’s manufacturing sites in-order to meet forecasted demand and target inventory/MOH levels

Lead/participate in cross-functional due diligence teams to assess new business opportunities and potential capabilities of a new CMO

Review, approve, and submit CMOs invoices for timely payments

Compliance & Documentation

Ensure all compliance-related documents, such as batch records, COC/COA, etc., for each order are accurate and available for Quality Assurance review and release

Arrange permits, state licenses, quality agreements, and service agreements to maintain GMP/GDP compliance

Review of CMO related change controls to understand the supply chain impact. Work closely with QA, regulatory, commercial and packaging teams to facilitate risk assessment & impact, along with approval process for the changes proposed/implemented at the CMO

Ensure the complete set of shipping documents is provided by the CMO/CPO including packing list, commercial/custom invoice, certificate of origin, BOL/AWB/HWB, EPICS file and all approved copies of COC’s and COA’s at the time of shipment

Data & Systems

Facilitate set up and validate material and vendor master data in SAP and related systems

Support the entire order-to-commercial cycle with proactive issue resolution

Liaison and support DSCSA compliance and serialization requirements with CMO’s Serialization team, collaborate with internal IT, and 3PL warehouse to ensure complete and timely implementation of GS1 EPCIS process to meet FDA requirements for new product launches and CMO’s on-boarded

Continuous Improvement

Lead cost optimization projects with partners to improve throughput and efficiency

Drive initiatives to mitigate supply chain risks and enhance operational resilience

Participate and drive Alternate Vendor Development (AVD) projects for evaluating and validating new API, excipients and RM vendors for dual-sourcing, cost savings and reliability optimization

Educational qualification: Postgraduate degree with specialization in Operations Management, Supply Chain Management or related field

Minimum work experience: 5-10 years of experience in cGMP pharmaceutical manufacturing or supply chain operations

Skills & attributes:

Proven experience in contract manufacturing management in an international environment

Strong operational expertise in pharmaceutical supply chain and generics business model

Proficiency in SAP, MS Office, and MS Project

Demonstrated ability to work with urgency, meet timelines, and ensure compliance

Excellent leadership and relationship-building skills across multicultural, multilingual environments

Strategic thinking with strong execution capability

Negotiation and alliance management skills

Problem-solving and proactive risk mitigation

Ability to influence across functions and geographies

Incumbent m ust be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring visa transfer or sponsorship, now or in the future.

Incumbent should be willing to work in person from our Princeton, NJ office

Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process.

Our Work Culture

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