Payrate: $45.00- $46.50/hr

Summary: The Contract Development and Manufacturing (ACDM) organization is seeking a highly qualified candidate to support synthetic-related outsourcing associated with execution of external development, commercial and clinical supply of drug substance (DS). The position will be focused on synthetic small molecule drug substance/process chemistry and serve as a key enabling role in a high-performing cross-functional organization. Individual projects may span development, sourcing (e.g., requests for proposal and site selection), supplier onboarding, manufacturing, and continuous improvement activities for both non-GMP and GMP commercial / clinical deliverables.

Responsibilities:

• Overseeing and supporting ongoing activities at selected sites along with any subcontracted sites to ensure project deliverables, including compliance, timelines, product quality, and cost
• Working closely with the ACDM team, Process Development, External Quality, Supply Chain, and other internal stakeholders to support sourcing activities, including managing scope of work (SoW) and quotation request documents
• Coordinating requests for shipment of materials/samples between sites
• Managing purchase orders, invoices, and project-related budget
• Overseeing deviations investigations and changing management as needed
• Maintain and update business-related trackers as needed
• Support continuous improvement projects and operational excellence within ACDM
• Performing other related duties and tasks as necessary or as assigned

Basic Qualifications:

• Bachelor’s degree in engineering, Chemistry, or Science-related field
• 4+ years of Manufacturing or Operations experience

Preferred Qualifications:

• Knowledge of synthetic drug development and manufacturing
• Experience in Project Management
• Understanding of cGMP, Operations and Regulatory/CMC policies and requirements, especially in the Pharmaceutical Industry
• Experience with interfacing and managing CRO and CDMO relationships
• Experience with change management, deviation investigations and implementation of corrective/preventive actions
• Understanding of tech transfer, drug development and commercialization of synthetic therapeutics
• Experience working in cross-functional settings, as part of cross-functional team or matrix team
• Strong interpersonal relationships and communication skills both written and verbal

Must Have Skills:

• Chemistry related industry/environment experiences
• Knowledge of synthetic drug development and manufacturing
• Experience in Project Management
• Understanding of cGMP, Operations and Regulatory/CMC policies and requirements, especially in the Pharmaceutical Industry

Pay Transparency: The typical base pay for this role across the U.S. is: $45.00- $46.50/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, life insurance benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

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