Senior Specialist, External Manufacturing

Job Description

Primary responsibilities for this position include, but are not limited to, the following: Lead and act as the primary interface on technical issues between technical operations and the external partner. Provide technical leadership within the technical operations group for the commercialization and manufacture of drug substance. Provides technical guidance to the external partner, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound. Collaborates with external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) performance, fostering pro-active risk management mindset and continuous improvement Executes technical due diligence assessments at external partner(s). Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities. Executes validation strategies for new and existing products. Provides manufacturing process support to external partner(s) to resolve production issues and to provide guidance on process and capacity optimization. Supports/coordinates/managescomplex investigations, with appropriate interface with other impacted manufacturing sites. Provides a technical review of external partner process change requests, deviations, and master batch record changes. Minimizes duplication of efforts between external partner and our systems. Drives and supports continuous process verification and process performance monitoring program for all products under his/her responsibility. Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements. Education and Minimum Requirements: Bachelor s degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer. Required Skills and Experience: Minimum of 5 of experience in drug substance with experience in leading Drug Substance new product introduction, technical transfers, commercial manufacturing. Demonstrated knowledge and experience in process development, scale up and process robustness, including shop floor (person in plant) support. Strong problem-solving skills, root cause analysis and riskassessment/mitigation. Ability to work effectively across boundaries to build strong collaborative relation with internal and external teams, to drive alignment and results. A high level of effectiveness in professional and interpersonal communication skills, including stakeholder management, are required. Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture. Must be able to work under own initiative, priorities appropriately based on business need and work within tight deadlines. Flexibility and the ability to work independently as well as excellent organizational skills. Strong knowledge of quality systems, drug substance manufacturing and validation. Excellent command of English (both written and oral). Travel will be a requirement of this position at approximately 25%. Preferred Experience and Skills: Knowledge and experience of flow chemistry, enzyme manufacture and bio-catalysis are desirable but not essential. Lean Manufacturing / Six Sigma Experience. Project management experience. Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.