Lead Process Scientist, Drug Product

Job Title

Sterile/fill-finish/lyo expert. (Vials, parenteral, biologics are areas that will have this) Writes dossiers Develops fill/finish validation strategies Can lead the technical portion of technology transfer. I don’t need a solid dose. It’s nice to have, but really need the put sterile powders and liquids into a vial piece.

Provide technical expertise within the GMSci DP/Pkg organizations relating to manufacturing technology and sciences for drug product manufacturing. Serves as the SME for leading major technology transfer or validation projects relating to new product introduction or life cycle management of existing products Provides leadership for regulatory interactions including CMC content for dossiers Ensures process knowledge is shared and leveraged across sites and functions Serves as Client’s global DP SME for issue resolution as needed

Serves as Client’s expert parenteral process and technologies, sterile, lyophilization Lead the following activities, along with Pharmaceutical Sciences and/or Operation Units: I) Technology Transfer to both CMOS and internal manufacturing facilities, ii) Drug Product manufacturing and packaging process validation – SME to develop a strategy iii) Write dossier sections and ensures fit for filing. iv) Serves as the experts for deployment as rapid response teams to serve all local manufacturing Operating Units Manage projects within Client product portfolio, both developments, and commercial, to support Manufacturing Sciences DP and Packaging Science activities Implement (AD/Sr Mgr) or provide input (Sr Professional) for strategies for the continuous improvement on the manufacturing of Marketed Products (a.k.a. matured products) in the late phase of the product life cycle.

Implement (AD/Sr Mgr) or provide input (Sr Professional) the manufacturing strategy for key Client products at internal manufacturing network and CMOS. Accountable for successful collaboration with a) Other functions within GMS b) Manufacturing Operating Unit Site leads c) Local Technical Services functions d) Pharmaceutical Sciences counterparts e) Other key functional groups such as Global Quality, Regulatory CMC, etc. AD level Provides above leaderships for multiple Client key products.

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application, and complexity of technical knowledge) SME for Client drug product manufacturing organization and network In-depth and broad (AD), solid (Sr Mgr), basic (Sr Professional) understanding of drug product manufacturing technologies for solid oral dosage form or injectable products Knowledge of industry’s best practices and innovative/emerging technology with the manufacturing of drug products (AD).

Good grasp (Sr Professional) of industry’s standard practices.

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change) Ability to influence within the organization, specifically with Pharmaceutical Sciences, GMS Operating Units and CMOs to drive decisions, alignment, and conflict resolution for complex cross-functional issues Effectively communicate and implement innovative and emerging technology for drug products within the Manufacturing Sciences organization. Able to communicate and influence decisions of Pharmaceutical Sciences development organization

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving) Able to independently make complex and key decisions impacting drug product manufacturing organizations (AD). Able to make decisions impacting the organization upon consultation with senior management (Sr. Mgr). With appropriate guidance, able to implement the decisions (Sr Professional)

Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships) Active engagement with development product implementation prior to commercialization to ensure the successful commercialization of key Client products. Actively…