Astellas Pharma Assistant Director, Project and Product Management in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose & Scope:
The Assistant Director is responsible for the planning and coordination of the Pharmaceutical Technology Division activities with minimal guidance from management. Leads and coordinates the conduct and timely completion of assigned projects, including internal input regarding project strategy and strategic plans with development collaboration partners.
This role provides leadership and substantial input to the identification, selection, and supervision of contract organizations including contract formulation, manufacturing and/or analytical method development labs as for both drug substances and drug products. Prepares budgets and other strategic forecasts for and provides limited input to departmental and divisional management.
Essential Job Responsibilities:
Plans and coordinates activities (drug substance and drug product development, commercialization and product management activities) on either a global or regional basis.
Represents the Pharmaceutical Technology Division on global and regional project teams to contribute divisional input on product development or commercialization strategy and tactics.
Leads strategic and tactical project teams and plans and tracks activities, identifies technical or resource issues, and takes independent remedial action if needed to prevent delays in timelines.
Leads and coordinates the evaluation and selection of appropriate organizations for development and commercial manufacturing activities and recommends selections to senior Pharmaceutical management. This includes both intra-divisional evaluation/selection activities (Technical, Supply Chain) and those of other divisions (QA, Procurement, Legal. Provides substantial input into the selection decision and the preparation and negotiation of resultant development and supply agreements.
Sees opportunities for improvement of business and technical processes within the regional or global PPM function and provides leadership of intra-divisional task teams.
Provides assessment of new external development collaboration opportunities, including participation on due diligence activities and preparation of due diligence reports.
Works closely with regional and global resources (including Clinical Supply Chain) for timely delivery of drug product for clinical studies, and to resolve technical questions or issues related to clinical supply packaging and labeling.
Provides short term and long-term budget forecasts to departmental management. Tracks project expenses and identifies/resolves discrepancies and remediation plans to ensure Divisional and Company financial objectives are met.
Working with global Regulatory Affairs, coordinates CMC submission preparation process for regional and/or global regulatory submissions. Interacts with QA and RA to resolve issues and questions pertaining to deliverables for such submissions.
Reviews CMC protocols and works with internal resources, contract organizations and/or development partners.
Reports to the Senior Director or Executive Director, PPM.
For assigned projects, collaborates closely with colleagues from regional and global Pharmaceutical Technology Division functions (CMC Laboratories, Supply Chain, Global and Regional PPM including Clinical Supply Chain, Product Security, internal manufacturing sites) and regional or global functions external to Pharmaceutical Technology Division (Development, Quality Assurance, Regulatory Affairs, Latin America business, Sales and Marketing, external manufacturing sites, development partners, GMS, GMA).
Interacts with functional management and senior management to drive decision-making and issue resolution.
M.S. or Ph.D. in Pharmacy, Pharmaceutics, life sciences or Chemistry plus five (5) years of experience in the pharmaceutical development of investigational drug candidates. OR
A B.S. in Pharmacy or Chemistry with additional relevant experience (7-10 years) can be considered.
Experience with the process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (oral solids, parenteral, topicals).
Working knowledge of current pharmaceutical industry processes and practices, and the ability to leverage this knowledge to optimize group and departmental processes.
Excellent communication and project management skills.
Ability to manage multiple projects and to work well within a team environment.
Solid understanding of GMP requirements and FDA/ICH guidance, as well as facility with commonly available computer tools used for project management and data evaluation.
Expertise in process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products).
Prior management of technical personnel (1-2 people).
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
401(k) Match and Annual Company Contribution
Company Paid Life Insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
Category Pharmaceutical Technology
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans