Director, Drug Product Technology Transfer

BioMarin

Technical Development Services (TDS) are hiring for a Director of Drug Product Technology Transfer (Sterile) with the following remit.

Provide technical and scientific leadership to the Drug Product Internal and External manufacturing network through partnerships with global functions and third-party Commercial Manufacturing Organisation’s (CMOs) to introduce new products and technologies;
Provide technical leadership in onboarding new commercial assets across all modalities and ensure their successful integration into the BioMarin Operating Model;
Accountable for the project execution and delivery of successful process characterisation, engineering, process performance and support to regulatory filing for drug product;
Driving excellence in Tech Transfer execution for Sterile Drug Product;
Project Portfolio Ownership.

Being the primary interface between GEO Manufacturing Operations, Internal Drug Product manufacturing and TDS for Technology Transfer and LCM;
The delivery of Technology Transfer across the Global External Operations and internal Manufacturing Network and successful handover to operations team;
Development and implementation of Tech Transfer best practices and standardisation across the Internal and external manufacturing network;
Supporting the development and execution of the Network Operations Strategy through Tech Transfer;
Successful delivery of the product development pipeline and commercialisation strategy;
The role will combine scientific, engineering, and operational leadership. This position requires a high degree of familiarity with cGMP and Quality Systems involved with commercial manufacturing processes.

Lead a team of scientists and engineers in the delivery of TT for Drug Product across our Global Manufacturing Network;
Manage and communicate the project portfolio to key stakeholders;
Identify, recruit, develop and retain qualified individuals to lead Tech Transfer;
Experienced in authoring, reviewing, and coaching of staff in regulatory filing submissions;
Create and maintain an environment of teamwork and collaboration while developing and motivating a high performing team that models the organisation values and attributes;
Serve as an influential member of the Drug Product and Packaging Development leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions;
Partner with Drug Product and Packaging Development leadership to provide technical expertise and discussion during GMP audits from regulatory authorities;
Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums;
Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools;
Participate in Global Partner Teams and CMC team as required.

Experience in the Biopharma, experience in Process Development and MSAT/Technical Development organizations is desirable;
10+ years of professional experience in the pharmaceutical industry, including managerial experience;
Demonstrated to lead and develop an effective team of scientists and engineers;
A broad understanding of Drug Productand a keen sense of business acumen;
Experience collaborating effectively with other functional groups to achieve business objectives;
Effective decision-making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders;
Demonstrated initiative; results oriented, initiative to institute change;
Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network;
Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.