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.
